GI SPORE Colon Biosample Protocol



Status:Completed
Conditions:Colorectal Cancer, Colorectal Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:11/10/2017
Start Date:September 2014
End Date:August 31, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

Biospecimens for the Diagnosis, Treatment and Prevention of Colorectal Cancer

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.


Inclusion Criteria:

5.2 General Eligibility Criteria 5.2.1 Overall Inclusion

1. Adults 18 years of age or older

2. Willing to sign informed consent.

3. Able to tolerate removal of up to 50 ml of blood

5.2.2 Overall Exclusion Criteria

1. Pregnant, lactating

2. Unable to understand English

3. Known HIV/AIDS or Hepatitis C

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

1. No prior colorectal neoplasia

2. Undergoing colonoscopy in the next 3-4 months OR had an endoscopically normal
colonoscopy within the previous 6 months.

3. Not prepped for colonoscopy at the time of blood draw

4. No personal history of colorectal cancer

5. 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)

1. Personal history of one or more adenomas or sessile serrated polyps in colon

2. Undergoing colonoscopy in the next 3-4 months

3. Not prepped for colonoscopy at the time of blood draw

4. No personal history of colorectal cancer

5. 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)

1. Newly diagnosed colon adenocarcinoma, any stage

2. No treatment received yet

3. Not prepped for colonoscopy or surgery at the time of blood draw

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

1. Newly diagnosed rectal adenocarcinoma, any stage

2. No treatment received yet

3. 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)

1. Personal history of colorectal adenocarcinoma within the last 5 years

2. Not prepped for colonoscopy at the time of blood draw

3. 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)

1. Personal history of colorectal adenocarcinoma greater than 5 years ago

2. Not prepped for colonoscopy at the time of blood draw

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

1. Personal or family history which meets clinical criteria for genetic evaluation for a
hereditary cancer syndrome

2. Not prepped for colonoscopy at the time of blood draw
We found this trial at
1
site
University of Michigan
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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mi
from
Ann Arbor, MI
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