MDACC Study Summary 2005-1011

Study Summary
No. 2005-1011:.......Colorectal......Robert S. Bresalier......Gastroenterology/Hepatology and Nutrition

Study Summary Title



Study Summary Number:	2005-1011

Study Title:	Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas

Physician

New Patient Referral



Name:	Robert S. Bresalier	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gastroenterology/Hepatology and Nutrition	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-5073 Contact us about clinical trials

General Information



Disease Group:	Colorectal	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Patients enrolled in this study will have a standard of care follow-up visit at 24-28 months post baseline visit.

Treatment Agents:	None	Home Care:	Subjects will be asked to collect stool samples at two different time points. One stool sample will be collected at baseline and one sample 24 to 28 weeks later as detailed in the study calendar (CRC and adenoma bins).

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Enrollment into this study will not increase the patient's length of stay or frequency of hospitalizations.

Description/
Intervention:

The goal of this clinical research study is to find out if stool or blood or
urine based markers (such as stool, blood, urine, rectal mucus, and tissue
samples) can be used to detect colon cancer as early as or earlier than
colonoscopy. Researchers want to use these samples and compare them in 3
groups of participants to learn about specific proteins or genes. This
information may help researchers find out if someone has colon adenomas
(polyps), colon cancer, or an increased risk for developing colon cancer.

Study Objectives / Outcomes

1 Assessment of the utility of individual stool-based, serum-based and urine-based biomarkers for discriminating between patients with adenocarcinomas, patients with adenomas, patients without adenomas and normal subjects.

2 Assessment of the utility of individual stool-based, serum-based and urine-based biomarkers for detecting indicators of carcinogenesis known to be present or not present in adenomas, adenocarcinomas, and normal mucosa.

3 Construction of a panel of markers from those considered in Objectives 1 and 2 to discriminate, under a number of assumptions concerning prevalence and cost of misclassification, between:
a Subjects with normal colons versus patients without adenomas, patients with adenomas and patients with cancers;
b Subjects with normal colons, patients without adenomas and patients with adenomas, versus subjects with cancers;
c Subjects with normal colons versus patients without and patients with adenomas versus patients with cancers.

4 Comparison of the characteristics of individual markers and panels as discriminators to those of the established current standard, Fecal Occult Blood test (FOBT).

5 Development of a bank of stool samples linked to serum, tissue, urine and clinical data from patients with colorectal cancer, adenomas and normal controls for validation of stool-based markers that may be developed in the future.

Study Status Information



Study Activation / Registration Date:	10/27/2006

IRB Review and Approval Date:	09/20/2006

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	800

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Willing to sign informed consent

2) Able to physically tolerate removal of up to 58 ml of blood at one to two different time points

3) Adults at least 18 years old

4) Willing to collect 1-2 stool samples and prepare a FOBT card and five specimen vials from each stool sample

5) Pregnant or nursing women who otherwise meet the eligibility criteria may participate

6) Subjects with one of the following: * Colorectal adenocarcinoma (not treated and in colon at time of stool collection) * Adenoma (pathologically confirmed adenoma present in colon at time of stool collection) * History of adenomas confirmed by pathology with none present on qualifying colonoscopy * History of colorectal cancer longer than 3 years ago with none present at qualifying colonoscopy * Any family (1st degree relative) history of colorectal cancer * No history or current finding of any colon neoplasia including colorectal cancer, adenomas, no personal or family history of HNPCC or FAP

7) Continuation from inclusion 6 : Subjects who had CRC that was successfully treated at least 3 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 normal bin * Subjects may be included in the normal or higher risk normal bin if their screening colonoscopy shows hyperplastic polyps, benign mucosal polyps, polypoid granulation tissue, prolapsed mucosal polyps, inflammatory polyp, transitional mucosal polyp, lipoma, gangleoneuroma, neuroma, or hamartomatous polyp.

Exclusion Criteria:

1) Cancer patients who have had any surgery, radiation, or chemotherapy for their current colorectal cancer prior to collecting the baseline samples

2) Patients with a history of or clinically active Inflammatory Bowel Disease

3) Inability to provide informed consent.

4) Other active malignancy within 3 years of enrollment except any of the following: a. Squamous cell carcinoma of the skin b. Basal cell carcinoma of the skin c. 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) d. Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery

5) Subjects with known HIV or chronic viral hepatitis

6) Patients with known HNPCC or FAP

Links

Registration Number: NCT00843375
Study Information on Clinical Trials Registry (clinicaltrials.gov)