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Completed

NCT Number: NCT02243267

GI SPORE Colon Biosample Protocol

The investigators are creating a data and specimen repository to study causes , early detection, prevention and treatment of colon and rectal cancer. The investigators are collecting data and specimens (blood, stool, urine and tissue) from people who have colon or rectal cancer, or who are risk for developing colorectal cancer or had normal colonoscopies. Data and samples are held in the repository until there are enough to be used for a large study or until there are new techniques that can be used to test them. The GI SPORE Program at the University of Michigan maintains a repository of specimens for colorectal diseases that the investigators hope will help fuel new research. The investigators hope that this work may lead to new treatments or earlier detection of colorectal cancer or improved diagnosis and treatment of other colon and rectal diseases.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

5.2 General Eligibility Criteria 5.2.1 Overall Inclusion

  • Adults 18 years of age or older
  • Willing to sign informed consent.
  • Able to tolerate removal of up to 50 ml of blood

5.2.2 Overall Exclusion Criteria

  • Pregnant, lactating
  • Unable to understand English
  • Known HIV/AIDS or Hepatitis C

5.3 Disease or Control Specific Eligibility Criteria 5.3.1 Unaffected Healthy Individuals (Healthy Controls)

  • No prior colorectal neoplasia
  • Undergoing colonoscopy in the next 3-4 months OR had an endoscopically normal colonoscopy within the previous 6 months.
  • Not prepped for colonoscopy at the time of blood draw
  • No personal history of colorectal cancer
  • No personal history of other cancers in the last 5 years (except basal/squamous skin lesions)

5.3.2 Prior non-invasive colorectal neoplasia (Adenoma surveillance)

  • Personal history of one or more adenomas or sessile serrated polyps in colon
  • Undergoing colonoscopy in the next 3-4 months
  • Not prepped for colonoscopy at the time of blood draw
  • No personal history of colorectal cancer
  • No personal history of other cancers in the last 5 years (except basal/squamous skin lesions)

5.3.3 New Diagnosis of Colon Adenocarcinoma (untreated, new colon CA)

  • Newly diagnosed colon adenocarcinoma, any stage
  • No treatment received yet
  • Not prepped for colonoscopy or surgery at the time of blood draw

5.3.4 New Diagnosis of Rectal Adenocarcinoma (untreated, new rectal CA)

  • Newly diagnosed rectal adenocarcinoma, any stage
  • No treatment received yet
  • Not prepped for colonoscopy or surgery at the time of blood draw

5.3.5 Colorectal Cancer (less than 5 years ago) (current/recent CRC)

  • Personal history of colorectal adenocarcinoma within the last 5 years
  • Not prepped for colonoscopy at the time of blood draw
  • No personal history of other cancers in the last 5 years (except basal/squamous skin lesions)

5.3.6 Colorectal Cancer (greater than 5 years ago)(remote history of colorectal cancer)

  • Personal history of colorectal adenocarcinoma greater than 5 years ago
  • Not prepped for colonoscopy at the time of blood draw

5.3.7 Hereditary Cancer syndrome (confirmed or suspected) (genetic risk of colorectal cancer)

  • Personal or family history which meets clinical criteria for genetic evaluation for a hereditary cancer syndrome
  • Not prepped for colonoscopy at the time of blood draw

Treatment and study plan

Sample collection

Other

Primary outcomes

  1. New Biomarker for colon cancer detection

    Time frame: 6 years

    To create a longitudinal biorepository from individuals with colorectal cancer, those who are high risk for developing colorectal cancer, and screened, endoscopically normal controls including a reference set of well annotated, pathologically confirmed tissue, plasma, serum, and white blood cell biosamples and corresponding demographic, risk, and clinical treatment data for improved colon cancer detection.

  2. Response to Treatment

    Time frame: 6 years

    To create a longitudinal biorepository from individuals with colorectal cancer, those who are high risk for developing colorectal cancer, and screened, endoscopically normal controls including a reference set of well annotated, pathologically confirmed tissue, plasma, serum, and white blood cell biosamples and corresponding demographic, risk, and clinical treatment data for improved colon cancer detection.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Biospecimens for the Diagnosis, Treatment and Prevention of Colorectal Cancer

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 17, 2014
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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