Non-Invasive Prediction of Colorectal Neoplasia
| Status: | Terminated |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | August 2006 |
| End Date: | December 2017 |
Hypothesis:The Adnab-9 antigen is a predictive biomarker in individuals at risk of
developing colorectal neoplasia.
Study aim is to evaluate the potential of the Adnab-9 monoclonal antibody (MAb) as a marker
of cancer risk in a population at increased risk for colorectal cancer (CRC). This marker
would be compared to other current and emerging diagnostic methods. 2,800 Veterans would be
recruited into the study. In phase 1, candidates would be defined as having increased CRC
risk by a short questionnaire. Stool samples would be obtained and a semi-quantitative
Adnab-9 antigen assay (ELISA) would be determined. Patients with differing high and low
estimations of fecal Adnab-9 would undergo colonoscopy at which time other samples of
effluent and colonic mucosa would be taken, and a detailed lifestyle and nutritional
questionnaire would be completed. The characteristics of the Adnab-9 fecal test as a
diagnostic test would be critically determined using the outcome of the colonoscopic and
other test results. The patients will be contacted through the mail and by word of mouth.
Informed consent will be obtained before the samples are obtained. The participants are
clinically defined as high-risk and therefore screening colonoscopy would be likely
performed in any event. A number of assays for Adnab-9 are feasible including slot-blot,
Western blot, and ELISA. Other stool studies include conventional fecal occult blood tests
(FOBT or FIT) that will be performed in tandem. The investigators therefore began this
method of collection and obtained consent from over 2000 patients with a similar overall
compliance rate with FOBT screening procedures to that reported previously of approximately
50%. Currently the study is no longer enrolling patients at the Detroit VA and is now
finalizing data entry. Another 450 patients to be recruited at the Philadelphia VAMC.
developing colorectal neoplasia.
Study aim is to evaluate the potential of the Adnab-9 monoclonal antibody (MAb) as a marker
of cancer risk in a population at increased risk for colorectal cancer (CRC). This marker
would be compared to other current and emerging diagnostic methods. 2,800 Veterans would be
recruited into the study. In phase 1, candidates would be defined as having increased CRC
risk by a short questionnaire. Stool samples would be obtained and a semi-quantitative
Adnab-9 antigen assay (ELISA) would be determined. Patients with differing high and low
estimations of fecal Adnab-9 would undergo colonoscopy at which time other samples of
effluent and colonic mucosa would be taken, and a detailed lifestyle and nutritional
questionnaire would be completed. The characteristics of the Adnab-9 fecal test as a
diagnostic test would be critically determined using the outcome of the colonoscopic and
other test results. The patients will be contacted through the mail and by word of mouth.
Informed consent will be obtained before the samples are obtained. The participants are
clinically defined as high-risk and therefore screening colonoscopy would be likely
performed in any event. A number of assays for Adnab-9 are feasible including slot-blot,
Western blot, and ELISA. Other stool studies include conventional fecal occult blood tests
(FOBT or FIT) that will be performed in tandem. The investigators therefore began this
method of collection and obtained consent from over 2000 patients with a similar overall
compliance rate with FOBT screening procedures to that reported previously of approximately
50%. Currently the study is no longer enrolling patients at the Detroit VA and is now
finalizing data entry. Another 450 patients to be recruited at the Philadelphia VAMC.
The primary objectives is to test the efficacy of Adnab-9 stool testing in a population at
high-risk for colorectal neoplasia and directly compare it to that of the FOBT and
secondarily, identify the source of the Adnab-9 antigen to determine influences of diet and
environment on its expression. The design is a prospective cross sectional (Part 1) and a
case-control longitudinal follow-up study (Part 2) using a brief questionnaire to assess
risk for cancer in a total of 2800 Part I patients will be enrolled designed to achieve a
database of high risk individuals and measure fecal Adnab-9 levels before a clinically
indicated colonoscopy is performed. The patients submit 4 FOBT cards in a routine manner by
mail, 3 are used for the FOBT and stool is extracted from the last card for the Adnab-9
ELISA which is reported as OD/5ug protein/well. 100 Part 2 enrollees are then selected on
the basis of positive fecal Adnab-9 test candidates matched with a like number of patients
with negative stool results who have had their initial colonoscopy and who will have a
5-year follow-up colonoscopy. Detailed Adnab-9 testing (immunohistochemical Adnab-9 binding;
blood biomarker estimations and Adnab-9 Western blotting) will be performed on various
bodily fluids to perfect the method of testing and completion of the detailed questionnaire
to check for reproducibility and interim lifestyle changes in these participants.
high-risk for colorectal neoplasia and directly compare it to that of the FOBT and
secondarily, identify the source of the Adnab-9 antigen to determine influences of diet and
environment on its expression. The design is a prospective cross sectional (Part 1) and a
case-control longitudinal follow-up study (Part 2) using a brief questionnaire to assess
risk for cancer in a total of 2800 Part I patients will be enrolled designed to achieve a
database of high risk individuals and measure fecal Adnab-9 levels before a clinically
indicated colonoscopy is performed. The patients submit 4 FOBT cards in a routine manner by
mail, 3 are used for the FOBT and stool is extracted from the last card for the Adnab-9
ELISA which is reported as OD/5ug protein/well. 100 Part 2 enrollees are then selected on
the basis of positive fecal Adnab-9 test candidates matched with a like number of patients
with negative stool results who have had their initial colonoscopy and who will have a
5-year follow-up colonoscopy. Detailed Adnab-9 testing (immunohistochemical Adnab-9 binding;
blood biomarker estimations and Adnab-9 Western blotting) will be performed on various
bodily fluids to perfect the method of testing and completion of the detailed questionnaire
to check for reproducibility and interim lifestyle changes in these participants.
Inclusion Criteria:
- ability to complete a consent form
- must be at above average risk for colorectal neoplasia
- physically able to undergo colonoscopy or barium enema
Exclusion Criteria:
- Mentally handicapped
- Physically infirm
- Low risk for colorectal neoplasia
- Pregnant individuals
- Vulnerable populations
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