Clinical trial NCT02243267: GI SPORE Colon Biosample Protocol
Official title: Biospecimens for the Diagnosis, Treatment and Prevention of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Rectal Cancer
Keywords: Colon Cancer Colon Cancer Prevention
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the University of Michigan Health System

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.


Eligibility criteria: 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

Primary outcomes:
measure: New Biomarker for colon cancer detection
timeFrame: 6 years
measure: Response to Treatment
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: