Colonic PolypsNIPCONNCT01815463
Non-Invasive Prediction of Colorectal Neoplasia
An observational study of Colonic Polyps and Polyposis Coli, run by Corporal Michael J. Crescenz VA Medical Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colonic Polyps, Polyposis Coli, Colorectal Cancer
- How many people
- 2,282 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Aug 2014
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Greater than average risk for colorectal neoplasia
Who may be able to join
- ability to complete a consent form
- must be at above average risk for colorectal neoplasia
- physically able to undergo colonoscopy or barium enema
Who cannot join
- Mentally handicapped
- Physically infirm
- Low risk for colorectal neoplasia
- Pregnant individuals
- Vulnerable populations
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Colonic Polyps, Polyposis Coli, Colorectal Cancer
- Keywords
- stool, monoclonal antibody, Adnab-9, FOBT, FIT, iFOBT, colonoscopy, barium enema, flexible sigmoidoscopy
- Medical subject headings
- Colonic Polyps, Adenomatous Polyposis Coli, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| colorectal neoplasia | No interventions Record colorectal neoplasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Adnab-9 stool result with outcome of colonoscopy
Stool is collected on guaiac stool cards and/or stool Polymedco sample bottle and extracted. Extracted stool is assayed for protein content and this is used as a standard for the Adnab-9 ELISA. Record review note colonoscopy outcome which is correlated with Adnab-9 ELISA result.
Measured: 10 years
Secondary outcomes (1)
Define the origin of the Adnab-9 bound antigen
Biopsies are taken at the time of colonoscopy in ~10% of initial enrollees, from 6 colonic segments. In addition colonic effluent. saliva, urine and blood samples are taken. ELISA and immunohistochemistry for Adnab-9 binding are performed.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startAug 2006
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Local PI did not submit annual renewal, still active in Detroit, not recruiting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Martin Tobi, Corporal Michael J. Crescenz VA Medical Center
- Investigators
- Martin Tobi, MB,ChB, Principal investigator, Philadelphia VAMC (WOC) Detroit VAMC (WOC) Saginaw VAMCFadi Antaki, MD, Principal investigator, Detroit VAMCJohn Lieb, MD, Principal investigator, Philadelphia PVAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815463
- Sponsor's protocol ID
- 00919
- Other IDs
- 0409000159
- Acronym
- NIPCON
- Status last verified
- Sep 2016
- First submitted
- 18 Mar 2013
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tobi M, Prabhu S, Gage RE, Orr T, Lawson MJ. Colorectal cancer risk: the impact of evidence of a field effect of carcinogenesis on blinded diagnosis using an anti-adenoma antibody test performed on colonoscopic effluent. Dig Dis Sci. 2002 Feb;47(2):317-21. doi: 10.1023/a:1013713920805.
PubMed 11855547Tobi M, Elitsur Y, Moyer MP, Halline A, Deutsch M, Nochomovitz L, Luk GD. Mucosal origin and shedding of an early colonic tumor marker defined by Adnab-9 monoclonal antibody. Scand J Gastroenterol. 1993 Dec;28(12):1025-34. doi: 10.3109/00365529309098304.
PubMed 8303203Tobi M, Maliakkal B, Zitron I, Alousi M, Goo R, Nochomovitz L, Luk G. Adenoma-derived antibody, Adnab-9 recognizes a membrane-bound glycoprotein in colonic tissue and effluent material from patients with colorectal neoplasia. Cancer Lett. 1992 Oct 30;67(1):61-9. doi: 10.1016/0304-3835(92)90009-k.
PubMed 1423246
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Prediction of Colorectal Neoplasia
- ClinicalTrials.gov ID
- NCT01815463
- Acronym / sponsor ID
- NIPCON / 00919
- Conditions
- Colonic Polyps, Polyposis Coli, Colorectal Cancer
- Keywords
- stool, monoclonal antibody, Adnab-9, FOBT, FIT, iFOBT, colonoscopy, barium enema
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Local PI did not submit annual renewal, still active in Detroit, not recruiting.
- Enrolment
- 2,282 participants (actual)
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical CenterUS federal agency
- Study start
- Aug 2006
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Mar 2013 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colorectal neoplasia | – | –No interventions Record colorectal neoplasia |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Greater than average risk for colorectal neoplasia
Key inclusion criteria (3 listed)
- ability to complete a consent form
- must be at above average risk for colorectal neoplasia
- physically able to undergo colonoscopy or barium enema
Key exclusion criteria (5 listed)
- Mentally handicapped
- Physically infirm
- Low risk for colorectal neoplasia
- Pregnant individuals
- Vulnerable populations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of Adnab-9 stool result with outcome of colonoscopy
Time frame: 10 years
Stool is collected on guaiac stool cards and/or stool Polymedco sample bottle and extracted. Extracted stool is assayed for protein content and this is used as a standard for the Adnab-9 ELISA. Record review note colonoscopy outcome which is correlated with Adnab-9 ELISA result.
1 secondary outcome
Define the origin of the Adnab-9 bound antigen
Time frame: 10 years
Results and safety
The study was stopped early (reason given: Local PI did not submit annual renewal, still active in Detroit, not recruiting.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Background: PubMed 11855547Tobi M, Prabhu S, Gage RE, Orr T, Lawson MJ. Colorectal cancer risk: the impact of evidence of a field effect of carcinogenesis on blinded diagnosis using an anti-adenoma antibody test performed on colonoscopic effluent. Dig Dis Sci. 2002 Feb;47(2):317-21. doi: 10.1023/a:1013713920805.
- Background: PubMed 8303203Tobi M, Elitsur Y, Moyer MP, Halline A, Deutsch M, Nochomovitz L, Luk GD. Mucosal origin and shedding of an early colonic tumor marker defined by Adnab-9 monoclonal antibody. Scand J Gastroenterol. 1993 Dec;28(12):1025-34. doi: 10.3109/00365529309098304.
- Background: PubMed 1423246Tobi M, Maliakkal B, Zitron I, Alousi M, Goo R, Nochomovitz L, Luk G. Adenoma-derived antibody, Adnab-9 recognizes a membrane-bound glycoprotein in colonic tissue and effluent material from patients with colorectal neoplasia. Cancer Lett. 1992 Oct 30;67(1):61-9. doi: 10.1016/0304-3835(92)90009-k.
- Individual participant dataSharing planned: No
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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.
Martin Tobi, MB,ChB principal investigator
Philadelphia VAMC (WOC) Detroit VAMC (WOC) Saginaw VAMC
Fadi Antaki, MD principal investigator
Detroit VAMC
John Lieb, MD principal investigator
Philadelphia PVAMC
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 Colonic Polyps and Polyposis Coli, run by Corporal Michael J. Crescenz VA Medical Center 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 27 Sep 2016. 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 was stopped early (reason given: Local PI did not submit annual renewal, still active in Detroit, not recruiting.). Results are not available in the source record.
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?
Correlation of Adnab-9 stool result with outcome of colonoscopy (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01815463, which also lists 3 linked publications.
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 27 Sep 2016.