Colorectal Cancer Trial, Recruiting NCT06864338 Sponsor: Mainz Biomed Condition: Colorectal Cancer
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Colorectal Cancer Trial, Recruiting

NCT06864338
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

This trial has two separate groups. A person may be eligible for one or both groups depending on their situation.

Group 1 – Screening Group

  • People of any sex who are 45 years of age or older
  • People who have been advised by their doctor to have a colonoscopy for screening purposes, or who already have one scheduled
  • People who are considered at average risk for bowel cancer, meaning they have no personal history of bowel cancer, adenomatous polyps (a type of growth in the bowel), or inflammatory bowel disease
  • People with no family history of bowel cancer in a parent, sibling, or child
  • People with no personal or family history of genetic conditions that increase the lifetime risk of bowel cancer, including conditions such as Familial Adenomatous Polyposis (FAP), Lynch Syndrome (also called HNPCC), Peutz-Jeghers Syndrome, Crohn's disease, ulcerative colitis, and several other hereditary syndromes (confirm with trial site for the full list)
  • People who are able to understand the study process and are willing to sign a consent form, including a form allowing the release of relevant health information
  • People who are able and willing to provide a stool (bowel) sample within 90 days before their colonoscopy
  • People who are able and willing to go ahead with a colonoscopy after providing their stool sample

Group 2 – Diagnostic Group

  • People of any sex who are 18 years of age or older
  • People who are willing and able to give informed consent to take part in the study
  • People who are suspected or confirmed to have bowel cancer or a large pre-cancerous growth, based on imaging, a positive screening test, or a colonoscopy that found something requiring further investigation
  • People who have not yet received any treatment for their condition (such as surgery, radiation, chemotherapy, or ablation) and still have at least one lesion (abnormal area) that is fully or partially intact
  • People who have a diagnostic colonoscopy or surgery scheduled within 90 days of providing their sample
  • People who are able to understand the study process and are willing to sign a consent form, including a form allowing the release of relevant health information
  • People who are able and willing to provide a stool sample within 90 days of enrolling and before any treatment begins

Who may not be able to join:

Group 1 – Screening Group

  • People who had any pre-cancerous findings on their most recent colonoscopy (non-cancerous or hyperplastic polyps do not count as an exclusion)
  • People who have had abnormal imaging results that suggested bowel cancer (such as MRI, CT scan, or barium enema)
  • People who have a history of certain other cancers, including cancers of the mouth, head and neck, lungs, oesophagus, stomach, liver, bile ducts, pancreas, small bowel, or appendix
  • People who have recently had a positive result from a non-invasive bowel screening test — specifically, a high-sensitivity stool blood test or immunochemical test within the past 12 months, or a stool DNA-FIT test within the past 36 months
  • People who have had a colonoscopy in the past 9 years (incomplete or failed colonoscopies may not count — confirm with trial site)
  • People who have previously had part of their bowel surgically removed, for any reason other than sigmoid diverticular disease (a condition affecting a specific part of the bowel)
  • People who have had visible rectal bleeding (such as blood in the toilet bowl) in the past 30 days (note: small amounts of blood from wiping does not count as rectal bleeding, according to the criteria)
  • People who have any other medical condition that the trial doctor believes would make participation unsuitable

Group 2 – Diagnostic Group

  • People who have been diagnosed with another tumour or cancer (other than non-melanoma skin cancer) in the past five years
  • People who have a prior diagnosis of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease
  • People who have any other medical condition that the trial doctor believes would make participation unsuitable

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Robert Bresalier, MD, M.D. Anderson Cancer Center

Phone: +49 (0) 613126514-18

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Mainz Biomed
Registry
ClinicalTrials.gov
Start date
18 December 2022
Est. completion
30 November 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Feasibility, test optimization, algorithm, and cut off ranges for the Mainz Biomed Colorectal Cancer Screening Test.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov