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Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study (CRC-PREVENT)

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ClinicalTrials.gov Identifier: NCT04739722
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : June 4, 2021
Sponsor:
Information provided by (Responsible Party):
Geneoscopy, Inc.

Brief Summary:
This study will be a prospective analysis conducted by Geneoscopy Inc. to evaluate the ColonoSight test, which is a multi-target stool RNA test for colorectal screening.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Advanced Adenocarcinoma Adenoma Colon Polyp of Colon Diagnostic Test: Colonosight Stool Sample Collection Kit Not Applicable

Detailed Description:
Patients who are eligible for a colonoscopy (i.e., asymptomatic, average risk individuals 45-84 years of age who are not up-to-date with screening guidelines) will be enrolled in the study. Stool samples returned to Geneoscopy's Laboratories by the participant will be subjected to the ColonoSight test system, and a result will be generated. The result will be compared to an optical colonoscopy to determine: 1) sensitivity for colorectal cancer, advanced adenomas, and other precancerous adenomas and 2) specificity for hyperplastic polyps and no findings on a colonoscopy. This study will be used for the clinical validation of the ColonoSight test.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study will be a prospective analysis conducted by Geneoscopy Inc. to evaluate the ColonoSight test, which is a multi-target stool RNA test for colorectal screening. Patients who are eligible for a colonoscopy (i.e., asymptomatic, average risk individuals between 45-80 who are not up-to-date with screening guidelines) will be enrolled in the study. Stool samples returned to Geneoscopy's Laboratories by the participant will be subjected to the ColonoSight test system, and a result will be generated. The result will be compared to an optical colonoscopy to determine: 1) sensitivity for colorectal cancer, advanced adenomas, and other precancerous adenomas and 2) specificity for hyperplastic polyps and no findings on a colonoscopy. This study will be used for the clinical validation of the ColonoSight test.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Validation of the ColonoSight Test: a Multi-target Stool RNA (Mt-sRNA) Assay for Colorectal Neoplasia Screening in Average-risk Individuals Aged >45 Years Old
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: ColonoSight Test
All participants will be evaluated with the Colonosight Test system and a colonoscopy.
Diagnostic Test: Colonosight Stool Sample Collection Kit
The ColonoSight Collection Kit provides information on how to collect a stool swab using a fecal immunochemical test (FIT) and how to collect a stool sample using the ColonoSight Collection Kit. After a stool sample is produced, patients will swab the stool sample using the FIT tube according to instructions and return the stool sample via mail courier to Geneoscopy's Laboratories. Patients will then be directed to receive a colonoscopy. If a lesion is removed during the colonoscopy, the tissue sample will be sent for histopathology review. The colonoscopy report and the histopathology report will be reported to Geneoscopy. Stool samples returned to Geneoscopy's Laboratories will be subjected to the ColonoSight test system, which includes targeted nucleic acid enrichment and biomarkers quantification via droplet digital polymerase chain reaction. The FIT returned in the ColonoSight Collection Kit will also be read by laboratory technologists at Geneoscopy.




Primary Outcome Measures :
  1. ColonoSight sensitivity for subjects with CRC [ Time Frame: 1 year ]
    ColonoSight sensitivity for subjects with CRC, which is the percentage of individuals with a diagnosis of colorectal cancer that were detected as positive by the ColonoSight test.

  2. ColonoSight sensitivity for subjects with Advanced Adenoma (AA) [ Time Frame: 1 year ]
    ColonoSight sensitivity for subjects with AA, which is the percentage of individuals with a diagnosis of advanced adenoma that were detected as positive by the ColonoSight test.

  3. ColonoSight sensitivity for subjects with high-grade dysplasia [ Time Frame: 1 year ]
    ColonoSight sensitivity for subjects with high-grade dysplasia, which is the percentage of individuals with a diagnosis of carcinoma in situ or advanced adenoma with high grade dysplasia that were detected as positive by the ColonoSight test.

  4. ColonoSight sensitivity for subjects with Other Adenomas (OAs) [ Time Frame: 1 year ]
    ColonoSight sensitivity for subjects with Other Adenomas (OAs), which is the percentage of individuals with a diagnosis of a non-advanced precancerous adenoma that were detected as positive by the ColonoSight test.

  5. ColonoSight specificity for subjects with negative findings [ Time Frame: 1 year ]
    ColonoSight specificity for subjects with negative findings, which is the percentage of individuals with a diagnosis of benign polyps, or no findings on a colonoscopy that were detected as negative by the ColonoSight test.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is male or female, >45 years of age
  • Subject is able to understand the study procedures, and is able to provide consent to participate in the study and authorizes release of relevant protected health information through reviewing and consenting to a HIPAA medical release form
  • Subject is able and willing to provide stool samples within the 120 days prior to a colonoscopy procedure.
  • Subject is able and willing to undergo a colonoscopy after providing a stool sample

Exclusion Criteria:

  • Subject had any precancerous findings on most recent colonoscopy. This does not include benign, and/or hyperplastic polyps of any size (Note: Tissue biopsies that result in no histopathology findings are acceptable)
  • Subject has a history or diagnosis of colorectal cancer
  • Subject has a history of aerodigestive tract cancer
  • Subject has had a positive non-invasive screening diagnostic within the associated recommended intervals

    • Fecal occult blood test or fecal immunochemical test within the previous twelve (12) months
    • FIT-DNA test within the previous 36 months
  • Subject has had a colonoscopy in the previous nine (9) years.
  • Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
  • Indication for colonoscopy was due to overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)
  • Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:

    • Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease
    • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP)
    • Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome")
    • Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04739722


Contacts
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Contact: Erica Barnell, PhD 314-713-5102 erica.barnell@geneoscopy.com
Contact: Andrew Barnell, MBA 314-795-3265 andrew.barnell@geneoscopy.com

Locations
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United States, Missouri
Geneoscopy, Inc. Recruiting
Saint Louis, Missouri, United States, 63146
Contact: Erica Barnell, PhD    314-713-5102    erica.barnell@geneoscopy.com   
Contact: Andrew Barnell, MBA    314-795-3265    andrew.barnell@geneoscopy.com   
Principal Investigator: Faith Holmes, MD         
Sub-Investigator: Lori Mayer, DNP, NP-C         
Sub-Investigator: George Atiee, MD         
United States, Texas
Elligo Health Research Recruiting
Austin, Texas, United States, 78738
Contact: Faith Holmes, MD    512-580-4633    faith.holmes@elligodirect.com   
Contact: Lori Mayer, DNP, NP-C    512-619-0758    lori.mayer@elligodirect.com   
Principal Investigator: Faith Holmes, MD         
Sub-Investigator: Lori Mayer, DNP, NP-C         
Sub-Investigator: George Atiee, MD         
Sponsors and Collaborators
Geneoscopy, Inc.
Investigators
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Study Chair: Elizabeth Wurtzler, PhD Geneoscopy, Inc.
Principal Investigator: Faith Holmes, MD Elligo Health Research
Additional Information:
Publications of Results:
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Responsible Party: Geneoscopy, Inc.
ClinicalTrials.gov Identifier: NCT04739722    
Other Study ID Numbers: Pro00045815
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Geneoscopy, Inc.:
Adenoma
Polyp
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenoma
Colonic Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Polyps
Pathological Conditions, Anatomical
Intestinal Polyps