Evaluating the Cologuard Test for Use in Lynch Syndrome

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Brief Title

Evaluating the Cologuard Test for Use in Lynch Syndrome

Official Title

Evaluating the Cologuard Test for Use in Lynch Syndrome

Brief Summary

      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

      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.
    


Study Type

Observational


Primary Outcome

Evaluate the feasibility of the Cologuard test for Lynch Syndrome

Secondary Outcome

 Evaluate patient satisfaction with Cologuard

Condition

Lynch Syndrome

Intervention

Cologuard test

Study Arms / Comparison Groups

 Cologuard Study Group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

90

Start Date

June 2021

Completion Date

September 2022

Primary Completion Date

May 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients age 18-89

          -  Diagnosis of genetically confirmed LS

          -  Scheduled for standard of care colonoscopy within 60 days of enrollment

        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)

          -  Others with elevated risk of CRC outside of the inclusion criteria (i.e. ≥2
             first-degree relatives who have been diagnosed with CRC without a defined inherited
             genetic disorder, Hereditary Non-Polyposis Colon Cancer (HNPCC) without genetic
             confirmation of LS)

          -  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
      

Gender

All

Ages

18 Years - 89 Years

Accepts Healthy Volunteers

No

Contacts

Rajiv Panikkar, MD, 5702716834, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04778566

Organization ID

2020-0239


Responsible Party

Principal Investigator

Study Sponsor

Geisinger Clinic


Study Sponsor

Rajiv Panikkar, MD, Principal Investigator, Geisinger Clinic


Verification Date

May 2021