MDACC Study Summary 2005-0737

Study Summary
No. 2005-0737:.......Esophageal......John R. Stroehlein......Gastroenterology/Hepatology and Nutrition

Study Summary Title



Study Summary Number:	2005-0737

Study Title:	Computer-Assisted Analysis of Brush Biopsy Specimens (EndoCDx) in the Detection of Esophageal Dysplasia: A Multicenter Prospective Clinical Trial

Physician

New Patient Referral



Name:	John R. Stroehlein	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:	Esophageal	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	N/A

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Length of stay and frequency of hospitalization is not effected by particpating in this study.


Description/ Intervention:	The goal of this clinical research study is to see if the addition of brush-biopsy to standard, forceps biopsy improves the detection of precancerous changes in the esophagus (food pipe) in people with Barrett's esophagus.

Study Objectives / Outcomes

This is a prospective, multicenter study designed to evaluate EndoCDx, a computer-assisted method of analysis of a brush biopsy, as an adjunct to standard endoscopic biopsy in the detection of esophageal dysplasia. The object of this study is to determine the percentage increase in detection of esophageal dysplasia from the addition of EndoCDx to standard esophageal biopsy practice.

The objective of the successful completion of this clinical trial is to provide gastroenterologists with an adjunctive tool to standard mucosal forceps biopsies that can be used to increase detection of patients with esophageal dysplasia. Specifically, the object of the study is to determine the percentage increase in detection of esophageal dysplasia from the addition of EndoCDx to standard esophageal biopsy practice.

Study Status Information



Study Activation / Registration Date:	06/02/2006

IRB Review and Approval Date:	02/15/2006

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	200-360

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) Both males and females will be enrolled and must be at least 18 years of age.

2) Patients with a history of Barrett's esophagus and dysplasia of either indefinite, low grade or high-grade.

3) Patients undergoing EGD who require either standard mucosal or jumbo forceps biopsies for surveillance.

4) Only patients who undergo both forceps biopsies and brush biopsies of the esophagus will be included in this study.

5) Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.

Exclusion Criteria:

1) Patients with visible lesions that are either submucosal or covered with a clinically intact epithelium.

2) Patients with a highly suspicious lesion, such as a nodule or ulcer, (noted while undergoing endoscopy) that the investigator chooses to immediately biopsy with a forceps prior to obtaining the brush biopsy, will be excluded from the study.

Links

Registration Number: Not Registered