GI SPORE Colon Biosample Protocol

NCT02243267 | Completed

• 1 other identifier: HUM00064405
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer; Rectal Cancer

Keywords

Colon Cancer Colon Cancer Prevention

Outcome Measures

Primary Outcomes (2)

• New Biomarker for colon cancer detection

  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.

  6 years

• Response to Treatment

  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.

  6 years

Interventions

sample collection OTHER

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the University of Michigan Health System

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Plasma Buffy Coat Tissue Stool Urine

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 17, 2014
• Study Start: September 1, 2014
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

US (1)