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Non-Invasive Prediction of Colorectal Neoplasia


N/A
18 Years
85 Years
Open (Enrolling)
Both
Colonic Polyps, Polyposis Coli, Colorectal Cancer

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Trial Information

Non-Invasive Prediction of Colorectal Neoplasia


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Correlation of Adnab-9 stool result with outcome of colonoscopy

Outcome Description:

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.

Outcome Time Frame:

10 years

Safety Issue:

No

Principal Investigator

Martin Tobi, MB,ChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

Philadelphia VAMC

Authority:

United States: Federal Government

Study ID:

00919

NCT ID:

NCT01815463

Start Date:

August 2006

Completion Date:

March 2015

Related Keywords:

  • Colonic Polyps
  • Polyposis Coli
  • Colorectal Cancer
  • stool
  • monoclonal antibody
  • Adnab-9
  • FOBT
  • FIT
  • iFOBT
  • colonoscopy
  • barium enema
  • flexible sigmoidoscopy
  • Neoplasms
  • Colonic Polyps
  • Colorectal Neoplasms
  • Adenomatous Polyposis Coli

Name

Location
Philadelphia VAMC Philadelphia, Pennsylvania  19104