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Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether stool or blood samples can find colon and rectal cancer as early as, or earlier than, a colonoscopy. Researchers will look for proteins that may signal cancer, polyps (growths in the colon), or cancer risk. Adults with cancer, certain polyps, or average or higher cancer risk may join.

Colon cancer is the second most common cancer in men and women. It is a disease that can be prevented if it is found early. Colonoscopy is still the best screening tool for colon cancer and the polyps that turn into colon cancer. However, due to a variety of factors, including affordability, time, and age, not all patients are able to be screened. Researchers are working on other options for early detection that are as accurate as colonoscopy. The purpose of this study if to determine if stool or blood can be used to detect colon cancers as early or earlier than colonoscopy. The researchers plan to use these samples to learn about specific proteins (also known as biomarkers) that may indicate colon polyps, colon cancer or an increased risk of developing colon cancer. In order to learn more about preventing and detecting colon and rectal cancer, we are collecting samples from subjects with cancer, adenomas, and colonoscopies who may be at risk for polyps.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old and willing to sign a form agreeing to join.
  • Be able to safely have up to 60 milliliters of blood drawn.
  • Be willing to collect 1–2 stool samples and prepare a FIT, a stool test for blood.
  • One eligible group has untreated colon or rectal cancer that is still present when stool is collected.
  • Another eligible group has an adenoma, a polyp confirmed by lab testing, present when stool is collected.
  • A higher-risk group includes people with past adenomas or colon or rectal cancer, but none on the qualifying colonoscopy; cancer must have been over 3 years ago. People with a parent, sibling, or child with this cancer, or a positive stool screening test within 12 months with no follow-up, may also qualify.
  • An average-risk group has no past or current colon or rectal cancer or precancerous growths, and no family history of this cancer. Some other types of noncancerous polyps are allowed.
  • Nursing women may join if they meet the other study rules.

Who can't join

  • Surgery, radiation, or chemotherapy for current colon or rectal cancer before the first samples are collected; or current chemotherapy or radiation for any reason.
  • Past or current inflammatory bowel disease, which causes swelling and irritation in the gut.
  • Known HNPCC or FAP, inherited conditions that raise colon cancer risk.
  • Unable to give informed consent, meaning agreement to join after learning about the study.
  • Another active cancer within 3 years of joining. Exceptions include basal or squamous cell skin cancer, certain early cervical cancers, and a specific early cancer of the womb lining. Some exceptions require surgery alone; pelvic radiation rules out the cervical cancer exception.
  • Known HIV or ongoing active viral hepatitis, a liver infection.
  • Pregnancy is listed as a reason not to join, but another part says pregnant women may join. Ask the study team to clarify.
  • Having CT colonography, also called a virtual colonoscopy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (11)

CA

IL

MA

  • Dana Farber Cancer Institute · Boston, MA 02215Sapna Syngal, MD · Principal investigatorMore trials in Boston

MI

MN

NC

NY

OR

PA

TX

  • M.D. Anderson Cancer Center · Houston, TX 77030Robert Bresalier, MD · Principal investigatorMore trials in Houston

WA

  • University of Washington · Seattle, WA 98195William Grady, MD · Principal investigatorMore trials in Seattle