Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ACRIN-6664 | Other Identifier | CIP | |
| U01CA079778 | U.S. NIH Grant/Contract | View source | |
| U01CA080098 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection.
PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Participants receive an oral laxative, oral bisacodyl, and three doses of oral barium sulphate 24 hours before imaging. After cathartic cleansing, participants undergo computed tomographic colonography followed by colonoscopy.
Participants are followed up for approximately 4 weeks.
PROJECTED ACCRUAL: A total of 2,607 participants will be accrued for this study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT Colonography | Experimental | CT colonography conducted during the same assessment as colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT Colonography | Procedure | CT colonography performed for comparison with colonoscopy results performed during the same screening assessment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=10mm (as measured at pathology) RS-: No Advanced adenomas >=10mm found by colonoscopy (as measured at pathology) | within 30 days |
| Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=9mm (as measured at pathology) RS-: No Advanced adenomas >=9mm found by colonoscopy (as measured at pathology) | within 30 days |
| Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=8mm (as measured at pathology) RS-: No Advanced adenomas >=8mm found by colonoscopy (as measured at pathology) | within 30 days |
| Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=7mm (as measured at pathology) RS-: No Advanced adenomas >=7mm found by colonoscopy (as measured at pathology) | within 30 days |
| Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | within 30 days |
Not provided
Inclusion Criteria
Exclusion Criteria
Symptoms of disease of the lower gastrointestinal tract, including
Inflammatory bowel disease and/or familial polyposis syndrome
Serious medical conditions that would increase the risk associated with colonoscopy or are so severe that screening would have no benefit
Pregnancy
Previous colonoscopy within the past five years
Anemia (hemoglobin less than 10 gm/dl)
Positive fecal occult blood test (FOBT)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| C. Daniel Johnson, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | United States | ||
| Moores UCSD Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21813740 | Background | Vanness DJ, Knudsen AB, Lansdorp-Vogelaar I, Rutter CM, Gareen IF, Herman BA, Kuntz KM, Zauber AG, van Ballegooijen M, Feuer EJ, Chen MH, Johnson CD. Comparative economic evaluation of data from the ACRIN National CT Colonography Trial with three cancer intervention and surveillance modeling network microsimulations. Radiology. 2011 Nov;261(2):487-98. doi: 10.1148/radiol.11102411. Epub 2011 Aug 3. | |
| 22361006 | Result | Johnson CD, Herman BA, Chen MH, Toledano AY, Heiken JP, Dachman AH, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon R, Fidler JL, Zimmerman P, Horton KM, Coakley KJ, Iyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Blevins M, Burgart LJ, Limburg PJ, Gatsonis CA. The National CT Colonography Trial: assessment of accuracy in participants 65 years of age and older. Radiology. 2012 May;263(2):401-8. doi: 10.1148/radiol.12102177. Epub 2012 Feb 23. |
| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
Not provided
Researchers may request data from the ACRIN data access committee by reviewing the information at:
https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
Not provided
Not provided
Not provided
Not provided
Of the 2607 registration events, 7 were registration errors [duplicate registrations due to system errors] and were cancelled. Therefore, a total of 2600 unique participants were enrolled to the study.
2600 asymptomatic, out-patients, 50 years or older and prescheduled for screening colonoscopy were recruited for CTC between February 2005 and December 2006.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CT Colonography | CT colonography conducted during the same assessment as colonoscopy. CT Colonography: CT colonography performed for comparison with colonoscopy results performed during the same screening assessment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CT Colonography | CT colonography conducted during the same assessment as colonoscopy. CT Colonography: CT colonography performed for comparison with colonoscopy results performed during the same screening assessment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=10mm (as measured at pathology) RS-: No Advanced adenomas >=10mm found by colonoscopy (as measured at pathology) | Posted | Count of Participants | Participants | within 30 days |
|
The adverse event reporting period for this protocol is defined as the period from the initiation of the Computed Tomography Colonography (CTC) procedure and self-reported events were collected for 30 days after the last primary intervention. All participants were monitored for 30days.
Grade 3 Expected and Unexpected AEs with attribution of possible, probable, or definite - Routine Grade 4 Expected AEs with attribution of possible, probable, or definite - Routine Grade 4 Unexpected AEs with attribution of possible, probable, or definite Expedited Report.
Grade 5 AEs, or Deaths with attribution of possible, probable, or definite Telephone Report and Expedited Report
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT Colonography | CT colonography conducted during the same assessment as colonoscopy. CT Colonography: CT colonography performed for comparison with colonoscopy results performed during the same screening assessment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hemorrhage with surgery | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | Hospitalization for observation of post-polypectomy bleeding. No transfusion required. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donna Harfeil, Director of Protocol Management | ACRIN | 215-717-2765 | dhartfeil@acr.org |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=6mm (as measured at pathology) RS-: No Advanced adenomas >=16mm found by colonoscopy (as measured at pathology) |
| within 30 days |
| Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=5mm (as measured at pathology) RS-: No Advanced adenomas >=5mm found by colonoscopy (as measured at pathology) | within 30 days |
| Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | within 30 days |
| Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | within 30 days |
| Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | within 30 days |
| Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | within 30 days |
| Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | within 30 days |
| Interobserver Sensitivity Variability | Evaluate interobserver variability in Sensitivity (P(T+|D+)) and 95% CI) when interpreting CTC examinations Each study was randomly assigned to be read independently using either a primary 2D search method (conventional 2D image display with 3D endoluminal problem solving), or a primary 3D search method (including the capability of displaying multiplanar 2D) and without prior knowledge of the colonoscopy results. A second trained radiologist of similar skill was assigned to read the images using the other modality Readers were then classified as high performing or not high performing | at baseline |
| La Jolla |
| California |
| 92093-0658 |
| United States |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States |
| Veterans Affairs Medical Center - San Francisco | San Francisco | California | 94121 | United States |
| Invision/Radiology Imaging Associates - Englewood | Englewood | Colorado | 80112 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06520-8028 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Clinical Radiologists, S.C. at Memorial Medical Center | Springfield | Illinois | 62781 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Mallinckrodt Institute of Radiology at Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| M.D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| 21364081 | Result | Hara AK, Blevins M, Chen MH, Dachman AH, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley KJ, Iyer RB, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Johnson CD. ACRIN CT colonography trial: does reader's preference for primary two-dimensional versus primary three-dimensional interpretation affect performance? Radiology. 2011 May;259(2):435-41. doi: 10.1148/radiol.11100250. Epub 2011 Mar 1. |
| 21512073 | Result | Hara AK, Kuo MD, Blevins M, Chen MH, Yee J, Dachman A, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Halvorsen RA Jr, Casola G, Johnson CD. National CT colonography trial (ACRIN 6664): comparison of three full-laxative bowel preparations in more than 2500 average-risk patients. AJR Am J Roentgenol. 2011 May;196(5):1076-82. doi: 10.2214/AJR.10.4334. |
| Result | Siewert B, Gareen I, Vanness D, et al.: ACRIN 6664: patient acceptance and preferance of CT colonography compared to optical colonoscopy for colon cancer screening. [Abstract] J Clin Oncol 27 (Suppl 15): A-4034, 2009. |
| 18799557 | Result | Johnson CD, Chen MH, Toledano AY, Heiken JP, Dachman A, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Burgart LJ, Limburg PJ. Accuracy of CT colonography for detection of large adenomas and cancers. N Engl J Med. 2008 Sep 18;359(12):1207-17. doi: 10.1056/NEJMoa0800996. |
| Withdrawal by Subject |
|
| Missing/incomplete CTC exam |
|
| Missing Reference Standard (Colonoscopy) |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=9mm (as measured at pathology) RS-: No Advanced adenomas >=9mm found by colonoscopy (as measured at pathology) | Posted | Count of Participants | Participants | within 30 days |
|
|
|
|
| Primary | Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=8mm (as measured at pathology) RS-: No Advanced adenomas >=8mm found by colonoscopy (as measured at pathology) | Posted | Count of Participants | Participants | within 30 days |
|
|
|
|
| Primary | Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=7mm (as measured at pathology) RS-: No Advanced adenomas >=7mm found by colonoscopy (as measured at pathology) | Posted | Count of Participants | Participants | within 30 days |
|
|
|
|
| Primary | Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=6mm (as measured at pathology) RS-: No Advanced adenomas >=16mm found by colonoscopy (as measured at pathology) | Posted | Count of Participants | Participants | within 30 days |
|
|
|
|
| Primary | Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=5mm (as measured at pathology) RS-: No Advanced adenomas >=5mm found by colonoscopy (as measured at pathology) | Posted | Count of Participants | Participants | within 30 days |
|
|
|
|
| Secondary | Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | Posted | Count of Units | lesions | within 30 days | lesions | lesions |
|
|
|
|
| Secondary | Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | Posted | Count of Units | lesions | within 30 days | lesions | lesions |
|
|
|
|
| Secondary | Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | Posted | Count of Units | lesions | within 30 days | lesions | lesions |
|
|
|
|
| Secondary | Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | Posted | Count of Units | lesions | within 30 days | lesions | lesions |
|
|
|
|
| Secondary | Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | Posted | Count of Units | lesions | within 30 days | lesions | lesions |
|
|
|
|
| Secondary | Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion) | Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | Posted | Count of Units | lesions | within 30 days | lesions | lesions |
|
|
|
|
| Secondary | Interobserver Sensitivity Variability | Evaluate interobserver variability in Sensitivity (P(T+|D+)) and 95% CI) when interpreting CTC examinations Each study was randomly assigned to be read independently using either a primary 2D search method (conventional 2D image display with 3D endoluminal problem solving), or a primary 3D search method (including the capability of displaying multiplanar 2D) and without prior knowledge of the colonoscopy results. A second trained radiologist of similar skill was assigned to read the images using the other modality Readers were then classified as high performing or not high performing | 15 readers read the 2531 case and their sensitivity was calculated as well as the variability (95% CI) in Sensitivity within 2 reader groups: High performing (HP) and not high performing (NHP). HP readers had both a sensitivity and specificity of > 85% for detecting polyps 10 mm and larger, NHP did not. | Posted | Mean | 95% Confidence Interval | probability of (test+ given disease+) | at baseline | Readers | Readers |
|
|
|
| 0 |
| 2,600 |
| 0 |
| 2,600 |
| 0 |
| 2,600 |
| EG001 | Colonoscopy | Colonoscopy conducted during the same assessment as CT colonography | 0 | 2,600 | 1 | 2,600 | 0 | 2,600 |
|
Not provided
Not provided
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| Sensitivity: P(T+|D+) |
| 0.9 |
| 2-Sided |
| 95 |
| 0.832 |
| 0.96 |
Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC |
| Other |
| Specificity CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | P(T-|D-) | 0.86 | 2-Sided | 95 | 0.817 | 0.902 | Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC. | Other |
| Positive Predictive Value (PPV) CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | P(D+|T+) | 0.25 | 2-Sided | 95 | 0.209 | 0.292 | Other |
| Negative Predictive Value (NPV) CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected" | P(D-|T-) | 0.99 | 2-Sided | 95 | 0.990 | 0.998 | Other |
| Sensitivity: P(T+|D+) |
| 0.87 |
| 2-Sided |
| 95 |
| 0.803 |
| 0.929 |
Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC |
| Other |
| Specificity | P(T-|D-) | 0.87 | 2-Sided | 95 | 0.825 | 0.909 | Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC. | Other |
| Positive Predictive Value (PPV) | P(D+|T+) | 0.31 | 2-Sided | 95 | 0.256 | 0.355 | Other |
| Negative Predictive Value (NPV) | P(D-|T-) | 0.99 | 2-Sided | 95 | 0.984 | 0.994 | Other |
| Sensitivity: P(T+|D+) |
| 0.84 |
| 2-Sided |
| 95 |
| 0.776 |
| 0.912 |
Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC |
| Other |
| Specificity | P(T-|D-) | 0.87 | 2-Sided | 95 | 0.831 | 0.914 | Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC. | Other |
| Positive Predictive Value (PPV) | P(D+|T+) | 0.35 | 2-Sided | 95 | 0.299 | 0.397 | Other |
| Negative Predictive Value (NPV) | P(D-|T-) | 0.99 | 2-Sided | 95 | 0.980 | 0.992 | Other |
| Sensitivity: P(T+|D+) |
| 0.78 |
| 2-Sided |
| 95 |
| 0.711 |
| 0.849 |
Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC |
| Other |
| Specificity | P(T-|D-) | 0.88 | 2-Sided | 95 | 0.840 | 0.92 | Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC. | Other |
| Positive Predictive Value (PPV) | P(D+|T+) | 0.4 | 2-Sided | 95 | 0.335 | 0.463 | Other |
| Negative Predictive Value (NPV) | P(D-|T-) | 0.98 | 2-Sided | 95 | 0.971 | 0.984 | Other |
| Sensitivity: P(T+|D+) |
| 0.65 |
| 2-Sided |
| 95 |
| 0.579 |
| 0.727 |
Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC |
| Other |
| Specificity | P(T-|D-) | 0.89 | 2-Sided | 95 | 0.851 | 0.923 | Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC. | Other |
| Positive Predictive Value (PPV) | P(D+|T+) | 0.45 | 2-Sided | 95 | 0.389 | 0.513 | Other |
| Negative Predictive Value (NPV) | P(D-|T-) | 0.95 | 2-Sided | 95 | 0.941 | 0.965 | Other |