Status:
COMPLETED
GI SPORE Colon Biosample Protocol
Lead Sponsor:
University of Michigan
Conditions:
Colon Cancer
Rectal Cancer
Eligibility:
All Genders
18-99 years
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 specimen...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- 2.2 Overall Exclusion Criteria
- Pregnant, lactating
- Unable to understand English
- Known HIV/AIDS or Hepatitis C
- 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)
- 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)
- 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
- 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
- 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)
- 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
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2017
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT02243267
Start Date
September 1 2014
End Date
August 31 2017
Last Update
November 8 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan
Ann Arbor, Michigan, United States, 48109