Colon CancerNCT02243267
GI SPORE Colon Biosample Protocol
An observational study of Colon Cancer and Rectal Cancer, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- sample collection
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 31 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of the University of Michigan Health System
Who may be able to join
- 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
Show all 38Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- sample collection
- Keywords
- Colon Cancer Colon Cancer Prevention
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sample collectionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Missy Tuck, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243267
- Sponsor's protocol ID
- HUM00064405
- Status last verified
- Nov 2017
- First submitted
- 11 Sep 2014
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biospecimens for the Diagnosis, Treatment and Prevention of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02243267
- Acronym / sponsor ID
- HUM00064405
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- Colon Cancer Colon Cancer Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the University of Michigan Health System
Key inclusion criteria (38 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sample collection | Other | – |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Rectal Cancer, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New Biomarker for colon cancer detection (time frame: 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.