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| Name | Class |
|---|---|
| University Hospitals Cleveland Medical Center | OTHER |
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A clinical study to determine the adequacy and efficacy of the InPath e2TM Collector compared to the FDA-approved spatula/cytobrush when used as the cell collection device in screening for cervical cancer.
The InPath e2TM Collector name has been changed to the CytoCore SoftPAP(R) Collector
The e2TM (SoftPAP) Collector collects only cells that have been exfoliated from the cervix whereas spatulas, brushes and broom-style collection devices collect cells by scraping or abrading the cervix. THis trial is to determine whether the purely exfoliated sample collected using the e2TM Collector is equivalent to samples obtained by scraping or abrading the cervix for purposes of cervical cancer screening and HPV detection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Experimental | e2 Cell Collector [SoftPAP(R)] |
| |
| Arm 2 - Control | Brush/spatula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e2 Cell Collector [SoftPAP(R)] | Device | Cervical cells collected using the e2 Cell Collector [SoftPAP(R)] |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cell Collection Efficacy | True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient. | At the time of cell collection. |
| Specimen Adequacy | Number and percentage of samples classified as adequate for diagnosis | At time of cell collection |
| Measure | Description | Time Frame |
|---|---|---|
| Human Papilloma Virus (HPV) Detection Frequency | Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay | At the time of cell collection. |
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Inclusion Criteria:
Exclusion Criteria:
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Women > 18 years of age with an abnormal pap within 30 days to 1 year for whom a colposcopy is scheduled.
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| Name | Affiliation | Role |
|---|---|---|
| Jay S. Pinkerton, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visions Clinical Research | Wellington | Florida | 33414 | United States | ||
| Comprehensive Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12571259 | Background | Munoz N, Bosch FX, de Sanjose S, Herrero R, Castellsague X, Shah KV, Snijders PJ, Meijer CJ; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003 Feb 6;348(6):518-27. doi: 10.1056/NEJMoa021641. | |
| 11693978 |
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Patients presenting for a previously scheduled colposcopy subsequent to an abnormal Pap result were recruited for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | SoftPAP | Samples collected using the SoftPAP Collector |
| FG001 | Brush/Spatula | Samples collected using an endocervical brush and cervical spatula |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Cervical cells
| Spatula/Brush | Device | Cervical cells collected using a combination of a cervical spatula and an endocervical brush |
|
| West Palm Beach |
| Florida |
| 33409 |
| United States |
| St. Louis University | St Louis | Missouri | 63106 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45206 | United States |
| University of Pittsburgh Medical Centers | Pittsburgh | Pennsylvania | 15213 | United States |
| Baylor Research Institute | Fort Worth | Texas | 75246 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23510 | United States |
| Sankaranarayanan R, Budukh AM, Rajkumar R. Effective screening programmes for cervical cancer in low- and middle-income developing countries. Bull World Health Organ. 2001;79(10):954-62. Epub 2001 Nov 1. |
| 15725861 | Background | Waxman AG. Guidelines for cervical cancer screening: history and scientific rationale. Clin Obstet Gynecol. 2005 Mar;48(1):77-97. doi: 10.1097/01.grf.0000151590.08451.26. No abstract available. |
| 10451450 | Background | Holowaty P, Miller AB, Rohan T, To T. RESPONSE: re: natural history of dysplasia of the uterine cervix. J Natl Cancer Inst. 1999 Aug 18;91(16):1420A-1421. doi: 10.1093/jnci/91.16.1420a. No abstract available. |
| 11966386 | Background | Solomon D, Davey D, Kurman R, Moriarty A, O'Connor D, Prey M, Raab S, Sherman M, Wilbur D, Wright T Jr, Young N; Forum Group Members; Bethesda 2001 Workshop. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA. 2002 Apr 24;287(16):2114-9. doi: 10.1001/jama.287.16.2114. |
| 10819705 | Background | Nanda K, McCrory DC, Myers ER, Bastian LA, Hasselblad V, Hickey JD, Matchar DB. Accuracy of the Papanicolaou test in screening for and follow-up of cervical cytologic abnormalities: a systematic review. Ann Intern Med. 2000 May 16;132(10):810-9. doi: 10.7326/0003-4819-132-10-200005160-00009. |
| 7702044 | Background | Fahey MT, Irwig L, Macaskill P. Meta-analysis of Pap test accuracy. Am J Epidemiol. 1995 Apr 1;141(7):680-9. doi: 10.1093/oxfordjournals.aje.a117485. |
| 11401314 | Background | Clavel C, Masure M, Bory JP, Putaud I, Mangeonjean C, Lorenzato M, Nazeyrollas P, Gabriel R, Quereux C, Birembaut P. Human papillomavirus testing in primary screening for the detection of high-grade cervical lesions: a study of 7932 women. Br J Cancer. 2001 Jun 15;84(12):1616-23. doi: 10.1054/bjoc.2001.1845. |
| 15774236 | Background | Willis BH, Barton P, Pearmain P, Bryan S, Hyde C. Cervical screening programmes: can automation help? Evidence from systematic reviews, an economic analysis and a simulation modelling exercise applied to the UK. Health Technol Assess. 2005 Mar;9(13):1-207, iii. doi: 10.3310/hta9130. |
| 8942687 | Background | Buntinx F, Brouwers M. Relation between sampling device and detection of abnormality in cervical smears: a meta-analysis of randomised and quasi-randomised studies. BMJ. 1996 Nov 23;313(7068):1285-90. doi: 10.1136/bmj.313.7068.1285. |
| 10577637 | Background | Martin-Hirsch P, Lilford R, Jarvis G, Kitchener HC. Efficacy of cervical-smear collection devices: a systematic review and meta-analysis. Lancet. 1999 Nov 20;354(9192):1763-70. doi: 10.1016/s0140-6736(99)02353-3. |
| 10796736 | Background | Martin-Hirsch P, Jarvis G, Kitchener H, Lilford R. Collection devices for obtaining cervical cytology samples. Cochrane Database Syst Rev. 2000;2000(2):CD001036. doi: 10.1002/14651858.CD001036. |
| 10907927 | Background | Selvaggi SM, Guidos BJ. Specimen adequacy and the ThinPrep Pap Test: the endocervical component. Diagn Cytopathol. 2000 Jul;23(1):23-6. doi: 10.1002/1097-0339(200007)23:13.0.CO;2-K. |
| 16218317 | Background | Marchand L, Mundt M, Klein G, Agarwal SC. Optimal collection technique and devices for a quality pap smear. WMJ. 2005 Aug;104(6):51-5. |
| 11214608 | Background | Koss LG. Evolution in cervical pathology and cytology: a historical perspective. Eur J Gynaecol Oncol. 2000;21(6):550-4. No abstract available. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SoftPAP | Samples collected using the SoftPAP Collector |
| BG001 | Brush/Spatula | Samples collected using an endocervical brush and cervical spatula |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Cell Collection Efficacy | True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient. | 79/348 (Arm 1) and 81/355 (Arm 2) participants were excluded from the sensitivity/specificity analysis due to biopsy (Bx) and/or endocervical curettage (ECC) results not being reported | Posted | Number | Participants | At the time of cell collection. |
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| Secondary | Human Papilloma Virus (HPV) Detection Frequency | Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay | Posted | Number | Participants | At the time of cell collection. |
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| Primary | Specimen Adequacy | Number and percentage of samples classified as adequate for diagnosis | Includes all cytology specimens | Posted | Number | Participants | At time of cell collection |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SoftPAP | Samples collected using the SoftPAP Collector | 0 | 348 | 0 | 348 | ||
| EG001 | Brush/Spatula | Samples collected using an endocervical brush and cervical spatula | 0 | 355 | 0 | 355 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Domanik, Ph.D. | CytoCore, Inc. | 312-222-9550 | rdomanik@cytocoreinc.com |
| ID | Term |
|---|---|
| D014099 | Toothbrushing |
| ID | Term |
|---|---|
| D009910 | Oral Hygiene |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
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| >=65 years |
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| Male |
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| False Positive (FP) (Cytology Dx vs (Bx + ECC)) |
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| False Negative (FN) (Cytology Dx vs (Bx + ECC)) |
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| Excluded - Bx/ECC results not reported |
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