Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00843375




Registration number
NCT00843375
Ethics application status
Date submitted
12/02/2009
Date registered
13/02/2009
Date last updated
30/01/2024

Titles & IDs
Public title
Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
Scientific title
Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
Secondary ID [1] 0 0
U01CA086400
Secondary ID [2] 0 0
UMCC 2018.126 GLNE 007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Higher risk, no neoplasia - Negative study colonoscopy and one or more of the following:

* Subjects with a personal history of adenomas (confirmed by pathology) with none present on qualifying colonoscopy
* Subjects with a personal history of colorectal cancer (CRC) (longer than 3 years ago because of exclusion criteria of cancer within last 3 years) with none present at time of qualifying colonoscopy
* Any family history of CRC (1st degree relative)
* Current positive screening stool test for blood, for DNA or for both within 12 months with no follow up intervention

Adenoma - Pathologically confirmed adenomas, both non-advanced adenoma and advanced. Advanced adenoma includes any of the following:

* Sessile serrated adenoma
* Tubulovillous adenoma
* Villous adenoma
* Sessile serrated polyp/adenoma
* Traditional serrated adenoma
* Any adenoma =1 cm

Colorectal adenocarcinoma - Pathologically confirmed colorectal cancer either present at time of stool collection or discovered during colonoscopy

Average risk, no neoplasia - No neoplasia found at colonoscopy and:

* No prior history of adenomas or sessile serrated adenomas
* No prior history of CRC
* No first degree family history of CRC
* Negative colorectal cancer screening test (if performed) for blood, for DNA or for both within 12 months.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Biospecimen Retention: Samples with DNA
Timepoint [1] 0 0
At 1 day of biospecimen collection

Eligibility
Key inclusion criteria
* Willing to sign informed consent
* Able to physically tolerate removal of up to 60 ml of blood
* Adults at least 18 years old
* Willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)
* Pregnant or nursing women who otherwise meet the eligibility criteria may participate
* Subjects with one of the following:

* Colorectal adenocarcinoma-not treated and in colon at time of stool collection (CRC bin)
* Adenoma-pathologically confirmed adenoma present in colon at time of stool collection (Adenoma Bin)
* Higher Risk Non-neoplastic Bin

* Subjects with a personal history of adenomas (confirmed by pathology) with none present on qualifying colonoscopy
* Subjects with a personal history of CRC (longer than 3 years ago because of exclusion criteria of cancer within last 3 years) with none present at time of qualifying colonoscopy
* Any family history of CRC (1st degree relative)
* Current positive screening stool test for blood, for DNA or for both within 12 months with no follow-up intervention.
* Average Risk, Non-neoplastic Bin

* No history or current finding of any colorectal neoplasia including CRC, adenomas, sessile serrated adenomas and no family history of CRC.
* Subjects who had CRC that was successfully treated at least three years ago may be considered eligible for the adenoma bin if their polyps are adenomas and there is no evidence of CRC, or for the higher risk non-neoplastic bin as noted above.
* Subjects whose screening colonoscopy shows any of these types of polyps may be included in the non-neoplastic or the higher risk non-neoplastic bin if they meet the other criteria noted above.

* Hyperplastic polyps
* Benign mucosal polyps
* Polypoid granulation tissue
* Prolapsed mucosal polyps
* Inflammatory polyp
* Transitional mucosal polyp
* Lipoma
* Gangleoneuroma
* Neuroma
* Hamartomatous polyp
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Cancer patients who have had any surgery, radiation, or chemotherapy for their current colorectal cancer prior to collecting the baseline samples
* History of or clinically active Inflammatory Bowel Disease
* Known HNPCC or FAP
* Inability to provide informed consent.
* Other active malignancy within 3 years of enrollment except any of the following:

* Squamous cell carcinoma of the skin
* Basal cell carcinoma of the skin
* Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery only. (Excluded if had pelvic radiation)
* Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery
* Patients on active chemotherapy or radiation treatment for any purpose
* Known HIV or chronic active viral hepatitis
* Women who are pregnant
* CT colonography (virtual colonoscopy) patients

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2028
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Center - Adelaide
Recruitment postcode(s) [1] 0 0
5001 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
University of Michigan Rogel Cancer Center
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Early Detection Research Network
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Clinical Genomics Pathology
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
VolitionRx
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
Department of Health and Human Services
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Great Lakes New England Clinical Validation Center
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Government body
Name [6] 0 0
National Cancer Institute (NCI)
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dean E Brenner, M.D.
Address 0 0
University of Michigan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cancer AnswerLine
Address 0 0
Country 0 0
Phone 0 0
1-800-865-1125
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00843375