Study for people with Colorectal Cancer

Recruiting Not a phased study

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Not a phased study
Sponsor University of Michigan Rogel Cancer Center
Registry number NCT00843375
Started 7 August 2019 Today 16 October 2026 Estimated completion 1 March 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Flinders Medical Center Adelaide SA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 1200

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Willing to sign informed consent

* Able to physically tolerate removal of up to 60 ml of blood

* Adults at least 18 years old

* Willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)

* Pregnant or nursing women who otherwise meet the eligibility criteria may participate

* Subjects with one of the following:

* Colorectal adenocarcinoma-not treated and in colon at time of stool collection (CRC bin)

* Adenoma-pathologically confirmed adenoma present in colon at time of stool collection (Adenoma Bin)

* Higher Risk Non-neoplastic Bin

* Subjects with a personal history of adenomas (confirmed by pathology) with none present on qualifying colonoscopy

* Subjects with a personal history of CRC (longer than 3 years ago because of exclusion criteria of cancer within last 3 years) with none present at time of qualifying colonoscopy

* Any family history of CRC (1st degree relative)

* Current positive screening stool test for blood, for DNA or for both within 12 months with no follow-up intervention.

* Average Risk, Non-neoplastic Bin

* No history or current finding of any colorectal neoplasia including CRC, adenomas, sessile serrated adenomas and no family history of CRC.

* Subjects who had CRC that was successfully treated at least three years ago may be considered eligible for the adenoma bin if their polyps are adenomas and there is no evidence of CRC, or for the higher risk non-neoplastic bin as noted above.

* Subjects whose screening colonoscopy shows any of these types of polyps may be included in the non-neoplastic or the higher risk non-neoplastic bin if they meet the other criteria noted above.

* Hyperplastic polyps

* Benign mucosal polyps

* Polypoid granulation tissue

* Prolapsed mucosal polyps

* Inflammatory polyp

* Transitional mucosal polyp

* Lipoma

* Gangleoneuroma

* Neuroma

* Hamartomatous polyp

Exclusion Criteria:

* Cancer patients who have had any surgery, radiation, or chemotherapy for their current colorectal cancer prior to collecting the baseline samples

* History of or clinically active Inflammatory Bowel Disease

* Known HNPCC or FAP

* Inability to provide informed consent.

* Other active malignancy within 3 years of enrollment except any of the following:

* Squamous cell carcinoma of the skin

* Basal cell carcinoma of the skin

* Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery only. (Excluded if had pelvic radiation)

* Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery

* Patients on active chemotherapy or radiation treatment for any purpose

* Known HIV or chronic active viral hepatitis

* Women who are pregnant

* CT colonography (virtual colonoscopy) patients

Dates on the record

Started 7 August 2019
Estimated completion 1 March 2028
Registry last updated 11 May 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 11 May 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.