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Low accrual
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Colorectal cancer arises from the mucosal layer of the colon. Current screening is performed by flexible endoscopy, which involves visual inspection of the mucosal lining of the colon and rectum with an optical camera mounted on the endoscope, with abnormal areas being biopsied. This method is somewhat limited in that there are no readily available surface pattern or morphological classification systems with adequate sensitivity or specificity to evaluate extent of submucosal invasion (deep, superficial, or none). Optical coherence tomography (OCT) using pattern recognition is a high-resolution imaging modality. There is currently an unmet need to predict depth of invasion for colonic tumors to decide on applicability of endoscopic (endoscopic submucosal dissection or endoscopic mucosal resection) vs. surgical therapy. The investigators' hypothesis is that OCT will have a higher diagnostic accuracy for determining depth of submucosal invasion compared to existing modalities. The investigators will first aim to assess the procedural feasibility and safety of using an OCT probe during routine colonoscopy with an early feasibility study. This study will identify appropriate modifications to the device and help with development of subsequent clinical study protocols. The eventual goal is to assess the diagnostic accuracy of OCT imaging for predicting depth of invasion of colonic tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optical coherence tomography (OCT) probe | Experimental | After consent, the endoscopist will perform a standard of care colonoscopy. If a polyp is found, then OCT will be used to image that polyp. Patients with polyps, regardless of number found, will have either one tubular adenoma (NICE type 2) imaged OR one hyperplastic polyp (NICE type 1) imaged. If no polyps are found, then one area of normal mucosa will be imaged. If on the rare chance a malignant appearing colonic tumor (NICE type 3) is found, this and no other polyps will be imaged with OCT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical coherence tomography probe | Device | The OCT probe is attached to an approximately 3-meter wire that is attached to the OCT fiber probe system setup. This setup consists of a power supply unit, and a control platform that controls fiber probe rotation and retraction. The OCT probe will be advanced through the colonoscope instrument channel |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Whose Procedure Length Using an OCT Probe During Routine Colonoscopy is Within 5 Minutes | If the proportion of the patients whose procedure length using an OCT probe during routine colonoscopy is within 5 minutes is greater than 75%, then the feasibility is defined in this study. | Within 5 minutes during standard of care colonoscopy - Day 1 (average length 3:40 minutes (full range 1:54-8:20 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events Related to OCT Imaging During Routine Colonoscopy | The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting. | From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Kushnir, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Optical Coherence Tomography (OCT) Probe | After consent, the endoscopist will perform a standard of care colonoscopy. If a polyp is found, then OCT will be used to image that polyp. Patients with polyps, regardless of number found, will have either one tubular adenoma (NICE type 2) imaged OR one hyperplastic polyp (NICE type 1) imaged. If no polyps are found, then one area of normal mucosa will be imaged. If on the rare chance a malignant appearing colonic tumor (NICE type 3) is found, this and no other polyps will be imaged with OCT. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2023 |
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| Number of Participants Who Have a Successfully Captured OCT Image Using Machine Learning Algorithm | Whether OCT image is successfully captured using machine learning algorithm, coded as "good" or "noisy". | During colonoscopy (Day 1) |
| Cohen's Weighted Kappa Score | Overall agreement (OCT probe yielding results consistent with clinical pathology biopsy results) as measured by Cohen's Kappa. Overall Cohen's Kappa is a statistical measure for assessing the reliability of agreement between the two results by taking into account the element of chance. Cohen's kappa can range from 0 to 1 with 1 indicating perfect agreement and 0 indicating an agreement equivalent to chance. Clinical pathology is the gold standard for diagnosis. Diagnosis from both OCT and clinical pathology will be assigned as normal mucosa, hyperplastic polyp, tubular adenoma, sessile serrated adenoma, or colorectal cancer. | During colonoscopy (Day 1) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Optical Coherence Tomography (OCT) Probe | After consent, the endoscopist will perform a standard of care colonoscopy. If a polyp is found, then OCT will be used to image that polyp. Patients with polyps, regardless of number found, will have either one tubular adenoma (NICE type 2) imaged OR one hyperplastic polyp (NICE type 1) imaged. If no polyps are found, then one area of normal mucosa will be imaged. If on the rare chance a malignant appearing colonic tumor (NICE type 3) is found, this and no other polyps will be imaged with OCT. |
| 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, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | Proportion of Participants Whose Procedure Length Using an OCT Probe During Routine Colonoscopy is Within 5 Minutes | If the proportion of the patients whose procedure length using an OCT probe during routine colonoscopy is within 5 minutes is greater than 75%, then the feasibility is defined in this study. | Posted | Count of Participants | Participants | Within 5 minutes during standard of care colonoscopy - Day 1 (average length 3:40 minutes (full range 1:54-8:20 minutes) |
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| Secondary | Number of Participants With Adverse Events Related to OCT Imaging During Routine Colonoscopy | The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting. | Posted | Count of Participants | Participants | From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days) |
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| Secondary | Number of Participants Who Have a Successfully Captured OCT Image Using Machine Learning Algorithm | Whether OCT image is successfully captured using machine learning algorithm, coded as "good" or "noisy". | 4 participants were excluded due to absence of polyps (n=1), probe malfunction (n=1), and poor image quality (n=2). | Posted | Count of Participants | Participants | During colonoscopy (Day 1) |
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| Secondary | Cohen's Weighted Kappa Score | Overall agreement (OCT probe yielding results consistent with clinical pathology biopsy results) as measured by Cohen's Kappa. Overall Cohen's Kappa is a statistical measure for assessing the reliability of agreement between the two results by taking into account the element of chance. Cohen's kappa can range from 0 to 1 with 1 indicating perfect agreement and 0 indicating an agreement equivalent to chance. Clinical pathology is the gold standard for diagnosis. Diagnosis from both OCT and clinical pathology will be assigned as normal mucosa, hyperplastic polyp, tubular adenoma, sessile serrated adenoma, or colorectal cancer. | 4 participants were excluded due to absence of polyps (n=1), probe malfunction (n=1), and poor image quality (n=2). | Posted | Number | 95% Confidence Interval | proportion of agreement | During colonoscopy (Day 1) |
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From start of colonoscopy through 48 hours after colonoscopy (estimated time of 3 days).
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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 | Optical Coherence Tomography (OCT) Probe | After consent, the endoscopist will perform a standard of care colonoscopy. If a polyp is found, then OCT will be used to image that polyp. Patients with polyps, regardless of number found, will have either one tubular adenoma (NICE type 2) imaged OR one hyperplastic polyp (NICE type 1) imaged. If no polyps are found, then one area of normal mucosa will be imaged. If on the rare chance a malignant appearing colonic tumor (NICE type 3) is found, this and no other polyps will be imaged with OCT. | 0 | 35 | 6 | 35 | 0 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Potential statin myopathy | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Hematochezia | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Ileal hemorrhage | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Fever | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| Right arm pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Hemorrhagic shock | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vladimir Kushnir, M.D. | Washington University School of Medicine | 314-362-3685 | vkushnir@wustl.edu |
| Feb 24, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Counts |
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| Participants |
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