Colorectal CancerreconAAsenseNCT05636085
Clinical Performance of the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer and Advanced Adenoma
An observational study of Colorectal Cancer and Colorectal Neoplasms, run by Mainz Biomed.
Trial summary
This study is to determine how the Mainz Biomed Colorectal Cancer Screening Test works when used in people aged ≥45 years of age and at an average risk of developing colorectal cancer. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Polyp
- What is being tested?
- Mainz Biomed Colorectal Cancer Screening Test
- Type of treatment
- Medical device
- How many people
- 15,000 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects that have been advised to have or are scheduled for a screening colonoscopy.
Who may be able to join
- 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 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
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- 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 able and willing to undergo a colonoscopy after providing a stool sample
Who cannot join
- Subject had any precancerous findings on most recent colonoscopy.
- Subject has a history of abnormal imaging suggesting colorectal cancer (e.g., colonography, MRI, CT, barium enema)
- Subject has a history of any of the following cancers: oral, head and neck, lung, esophagus, gastric, biliary/liver, pancreatic, small bowel, or appendiceal
- Subject has had a positive non-invasive screening diagnostic within the associated recommended intervals
- High-sensitivity fecal occult blood test or fecal immunochemical test within the previous twelve (12) months
- sDNA-FIT test within the previous thirty-six (36) months
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- 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 due to overt rectal bleeding (e.g., hematochezia or melena) within the previous thirty (30) days
- Subject has any condition that in the opinion of the investigator should preclude participation in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Performance of the Mainz Biomed Colorectal Cancer Screening Test for the Detection of Colorectal Cancer and Advanced Adenoma in an Average Risk Population
This study is to determine how the Mainz Biomed Colorectal Cancer Screening Test works when used in people aged ≥45 years of age and at an average risk of developing colorectal cancer.
Read the detailed description
This study is to validate the clinical performance for the Mainz Biomed Colorectal Cancer Screening Test in an average risk population aged ≥45 years of age.
Stool samples will be collected from subjects ≥45 years of age, of average risk for colon cancer, and scheduled to have a screening colonoscopy. The samples will be collected prior to colonoscopy and will be tested with the Mainz Biomed Colorectal Cancer Screening Test. The results will be compared with colonoscopy results to determine test performance.
- Being tested
- Mainz Biomed Colorectal Cancer Screening Test
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mainz Biomed Colorectal Cancer Screening TestDevice
There is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Eligible subjects | Subjects ≥45 years of age and at average risk of colorectal cancer. Receives: Device: Mainz Biomed Colorectal Cancer Screening Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity Colorectal Cancer
Sensitivity of the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer
Measured: 18 to 24 months
Sensitivity Advanced Adenoma
Sensitivity of the Mainz Biomed Colorectal Cancer Screening Test for Advanced Adenoma
Measured: 18 to 24 months
Specificity
Specificity of the Mainz Biomed Colorectal Cancer Screening Test for Advanced Neoplasia
Measured: 18 to 24 months
Secondary outcomes (1)
Positive predictive value and negative predictive value
Determine the positive predictive value and negative predictive value for the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer, Advanced Adenoma, and Advanced Neoplasia
Measured: 18 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start31 Dec 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mainz Biomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danielle Kim Turgeon, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636085
- Sponsor's protocol ID
- MNZ-CRC-001
- Acronym
- reconAAsense
- Status last verified
- Mar 2025
- First submitted
- 23 Nov 2022
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of the Mainz Biomed Colorectal Cancer Screening Test for the Detection of Colorectal Cancer and Advanced Adenoma in an Average Risk Population
- ClinicalTrials.gov ID
- NCT05636085
- Acronym / sponsor ID
- reconAAsense / MNZ-CRC-001
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Mainz BiomedIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to determine how the Mainz Biomed Colorectal Cancer Screening Test works when used in people aged ≥45 years of age and at an average risk of developing colorectal cancer.
Detailed description
This study is to validate the clinical performance for the Mainz Biomed Colorectal Cancer Screening Test in an average risk population aged ≥45 years of age.
Stool samples will be collected from subjects ≥45 years of age, of average risk for colon cancer, and scheduled to have a screening colonoscopy. The samples will be collected prior to colonoscopy and will be tested with the Mainz Biomed Colorectal Cancer Screening Test. The results will be compared with colonoscopy results to determine test performance.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible subjects | – | Device: Mainz Biomed Colorectal Cancer Screening TestSubjects ≥45 years of age and at average risk of colorectal cancer. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects that have been advised to have or are scheduled for a screening colonoscopy.
Key inclusion criteria (13 listed)
- 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:
- 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
Key exclusion criteria (10 listed)
- Subject had any precancerous findings on most recent colonoscopy.
- Subject has a history of abnormal imaging suggesting colorectal cancer (e.g., colonography, MRI, CT, barium enema)
- Subject has a history of any of the following cancers: oral, head and neck, lung, esophagus, gastric, biliary/liver, pancreatic, small bowel, or appendiceal
- Subject has had a positive non-invasive screening diagnostic within the associated recommended intervals
- Subject has had a colonoscopy in the previous nine (9) years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mainz Biomed Colorectal Cancer Screening TestThere is no intervention. | Device | Eligible subjects |
Primary outcome
Sensitivity Colorectal Cancer
Time frame: 18 to 24 months
Sensitivity of the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer
Sensitivity Advanced Adenoma
Time frame: 18 to 24 months
Sensitivity of the Mainz Biomed Colorectal Cancer Screening Test for Advanced Adenoma
Specificity
Time frame: 18 to 24 months
Specificity of the Mainz Biomed Colorectal Cancer Screening Test for Advanced Neoplasia
1 secondary outcome
Positive predictive value and negative predictive value
Time frame: 18 to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danielle Kim Turgeon, MD principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colorectal Neoplasms, run by Mainz Biomed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lena Krammes, PhD (+49 (0) 613126514-18, lena.krammes@mainzbiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity Colorectal Cancer (time frame: 18 to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.