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

Conditions

• Colonic Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Aug 7, 2019

Status verified

May 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

1,200 participants (estimated)

Arms

• Arm: Higher risk, no neoplasia
  Negative study colonoscopy and one or more of the following: * Subjects with a personal history of adenomas (confirmed by pathology) with none present on qualifying colonoscopy * Subjects with a personal history of colorectal cancer (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
• Arm: Adenoma
  Pathologically confirmed adenomas, both non-advanced adenoma and advanced. Advanced adenoma includes any of the following: * Sessile serrated adenoma * Tubulovillous adenoma * Villous adenoma * Sessile serrated polyp/adenoma * Traditional serrated adenoma * Any adenoma ≥1 cm
• Arm: Colorectal adenocarcinoma
  Pathologically confirmed colorectal cancer either present at time of stool collection or discovered during colonoscopy
• Arm: Average risk, no neoplasia
  No neoplasia found at colonoscopy and: * No prior history of adenomas or sessile serrated adenomas * No prior history of CRC * No first degree family history of CRC * Negative colorectal cancer screening test (if performed) for blood, for DNA or for both within 12 months.

Primary Outcome Measure

Biospecimen Retention: Samples with DNA [ Time Frame: At 1 day of biospecimen collection ]

Central Contacts

• Cancer AnswerLine
  1-800-865-1125
  [email protected]

Locations (11)

Find similar trials in Los Angeles, CA

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