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Evaluating the Cologuard Test for Use in Lynch Syndrome

NCT ID: NCT04778566

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-09-30

Brief Summary

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This study is aiming to enroll 90 patients with genetically confirmed Lynch Syndrome (LS) from Geisinger's High Risk Colorectal Cancer Clinic (HRC). Upon enrollment in the study, a Cologuard test will be ordered and the results will be blinded until data analysis. Patients enrolled in the study will also undergo a colonoscopy as part of their routine HRC visit.

Detailed Description

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The primary aim is to perform a pilot study to gain information toward the implementation of a larger prospective study that will compare the performance of Cologuard with the gold-standard colonoscopy in identifying advanced adenomas and colorectal cancers in LS. Data regarding rate of consent, and adherence to the protocol will be recorded. Since patients with known genetic predisposition to cancers tend to view screening tests more positively than the general population, a second aim of the study is to evaluate patient satisfaction with bowel preparation, colonoscopies, and Cologuard testing. Up to 90 individuals with genetically confirmed LS will be recruited via Geisinger's HRC to complete a goal of 90 Cologuard studies. Upon enrollment, Cologuard will be ordered by the study team at no cost to the subject and will be completed according to the standard instructions for use. Results will be securely obtained and blinded until the time of data analysis. Subjects will undergo colonoscopy as part of their routine HRC visit. Results from the colonoscopy (and biopsy as indicated) will be retrieved from the Electronic Health Record (EHR) and documented in a research-associated spreadsheet. If repeat colonoscopy is clinically indicated, repeat Cologuard may be completed if the subject meets inclusion criteria.

Conditions

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Lynch Syndrome Colorectal Cancer Colonic Adenoma Colonic Polyp

Keywords

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Lynch Syndrome Colorectal Cancer Hereditary non-polyposis colon cancer High-Risk Colon Cancer Health-Related Quality of Life Bowel Prep Tolerability Colonoscopy Procedural anxiety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cologuard Study Group

Within 60 days of their already scheduled screening colonoscopy, participants will provide a stool sample to be tested by a Cologuard screening test kit. Participants will also complete surveys prior to their colonoscopy as well as post colonoscopy.

Cologuard test

Intervention Type DIAGNOSTIC_TEST

Cologuard is a stool-DNA screening test for detecting colon cancer

Interventions

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Cologuard test

Cologuard is a stool-DNA screening test for detecting colon cancer

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients age 18-89
* Diagnosis of genetically confirmed LS
* Scheduled for standard of care colonoscopy within 60 days of enrollment

* Participation in any interventional clinical study within the previous 30 days
* Personal history of CRC not in full remission (5 consecutive cancer-free years)
* Current active treatment with chemotherapy
* Treatment with chemotherapy within 12 months prior to consent date

Exclusion Criteria

* Diagnosis of other inherited genetic disorders that increase risk for Colorectal Cancer (CRC) (Familial Adenomatous Polyposis (FAP), Cowden's syndrome, Turcot syndrome, Gardner syndrome, and Peutz-Jeghers syndrome)
* Diagnosis of other inherited Inflammatory bowel disease (i.e. Crohn disease, ulcerative colitis)
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Geisinger Clinic

OTHER

Sponsor Role lead

Responsible Party

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Rajiv Panikkar

Sponsor - Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rajiv Panikkar, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

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Geisinger Health

Danville, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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2020-0239

Identifier Type: -

Identifier Source: org_study_id