Pilot Study for Colorectal Cancer and Advanced Adenoma Detection With the Mainz Biomed Colorectal Cancer Test (eAArly DETECT)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The Mainz Biomed Colorectal Cancer Screening Test is being studied for its performance in the identification of the presence of colorectal cancer (CRC) or advanced adenoma (AA) in the colon in patients at average risk for colorectal cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Subject is any sex and ≥45 years of age

• Subject must be advised to have or be scheduled for a screening colonoscopy

• Subject is at average risk for colorectal cancer according to the United States Preventive Services Task Force (USPSTF) guidelines, including:

‣ no prior diagnosis of colorectal cancer, adenomatous polyps, or inflammatory bowel disease

⁃ no family history of colorectal cancer (defined as one or more first degree relatives including parent, sibling, or child)

⁃ no personal diagnosis or family history of known genetic disorders that predispose them to a high lifetime risk of colorectal cancer including:

• 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 or 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, Neurofibromatosis and Familial Hyperplastic Polyposis

∙ Cronkhite Canada Syndrome

• Subject can 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 Health Insurance Portability and Accountability Act (HIPAA) medical release form

• Subject is able and willing to provide stool samples within ninety (90) days before the colonoscopy procedure

• Subject is any sex and ≥ 18 years of age

• Subject is able and willing to give informed consent

• Through imaging, a positive non-invasive screening test, or colonoscopy requiring additional intervention subject is suspected or known to have Colorectal Cancer or Advanced Adenoma

• Subject has not yet been treated (e.g., ablation, surgical resection, radiation, chemotherapy, etc.) and still has at least one intact or partially intact lesion

• Subject must have a diagnostic colonoscopy or surgical intervention scheduled within 90 days of sample collection

• Subject can 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 Health Insurance Portability and Accountability Act (HIPAA) medical release form

Locations
United States
North Carolina
Virtual Research Group
RECRUITING
Morrisville
Contact Information
Primary
Lena Krammes, PhD
lena.krammes@mainzbiomed.com
+49 (0) 613126514-18
Backup
Christian Von Toerne, PhD
christian.vontoerne@mainzbiomed.com
+49 (0) 173 1621928
Time Frame
Start Date: 2022-12-18
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 2700
Treatments
Individuals aged 45 and over at average risk of colorectal cancer.
Individuals aged 45 and older that are advised to have or are scheduled for a screening colonoscopy and are at average risk for colorectal cancer.
Individuals aged 18 and older suspected or known to have at least one precancerous, intact lesion.
Individuals aged 18 and older that are suspected to have at least one advanced precancerous lesion or colorectal cancer. Subjects in this group are those that have been pre-identified with imaging, a positive non-invasive screening test, and/or colonoscopy which requires additional intervention.
Related Therapeutic Areas
Sponsors
Leads: Mainz Biomed

This content was sourced from clinicaltrials.gov