MDACC Study Summary 2007-0174

Study Summary
No. 2007-0174:.......Esophageal......Robert S. Bresalier......Gastroenterology/Hepatology and Nutrition

Study Summary Title



Study Summary Number:	2007-0174

Study Title:	Preliminary longitudinal validation of biomarkers predictive of Barrett's esophagus progression to dysplasia and adenocarcinoma

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:	Esophageal	Supported By:	NCI

Phase of Study:	N/A	Return Visit:	Specimen collection should only occur twice in one year followed by every 2-3 years for subjects with IM alone, or every 6 months for subjects with Indefinite-for-dysplasia.

Treatment Agents:	None	Home Care:	Not applicable

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	Not applicable. Hospitalization is not expected as the esophagoduodenal (EGD) procedure is performed on an outpatient basis.


Description/ Intervention:	The goal of this clinical research study is to look at proteins and genes of patients with Barrett's esophagus in order to learn how this condition does or does not lead to cancer.

Study Objectives / Outcomes

There are 2 goals for this phase of the proposed research:

To create a longitudinal cohort of individuals with metaplastic Barrett's esophagus, with a reference set of well annotated pathologically confirmed biosamples, for use in biomarker discovery.

To make a preliminary assessment if one or more of the biomarkers, over time, predict patients' conversion from intestinal metaplasia (IM) to high grade dysplasia (HGD) or esophageal adenocarcinoma (EAC).

This protocol is linked to the ongoing GLNE 003 protocol "Preliminary Validation of Biomarkers Predictive of Barrett's Esophagus Progression to Dysplasia and Adenocarcinoma." The 003 protocol collects biosamples from human subjects with intestinal metaplasia (IM), low grade dysplasia (LGD), high grade dysplasia (HGD), esophageal adenocarcinoma (EAC), and no disease in the esophagus (control). The goal of 003 is to create a cross-sectional reference set of these diagnostic groups to support biomarker discovery and prevalidation.

This protocol, GLNE 008 is a longitudinal cohort study of patients with Barrett's intestinal metaplasia. The primary aim of this new protocol is to create a GCP quality longitudinal reference biosample set of serum, plasma, tissue (fixed and frozen), esophageal cytology, urine, and DNA from circulating white blood cells obtained from individuals with Barrett's IM, for use in discriminating those patients who progress to HGD or EAC, versus those who do not. The analysis of biomarkers will take place when sufficient samples and/or data and/or technology are available. The study will enroll only individuals with non-dysplastic Barrett's metaplasia.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	08/30/2007

Study Type:	Other

Recruitment Status:	Open

Projected Accrual:	750

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) Adults (> 18 years old)

2) Subjects with pathologically confirmed Barrett's esophagus including: a. Intestinal metaplasia without dysplasia long and short segments (>1 cm); b. Intestinal metaplasia without dysplasia, long and short segments (>1 cm), previously in GLNE 003; c. Intestinal metaplasia without dysplasia with indefinite-for-dysplasia (or history of indefinite- for-dysplasia) provided there is no history of HGD or EAC;

3) (#2 continued) d. Intestinal metaplasia without dysplasia or indefinite-for-dysplasia with a history of LGD provided the last surveillance endoscopy showed IM alone, the LGD history was at least 12 or more months ago and there is no history of HGD or EAC.

4) Able to physically tolerate removal of 34 ml of blood

5) Tolerate extra research related biopsies and brushings

6) Willing to permit extra biopsies at future endoscopic procedures

7) Ability and willingness to complete questionnaires

8) Willing to sign informed consent

Exclusion Criteria:

1) Subjects with a pathologically confirmed history of Barrett's HGD, or EAC

2) Subjects in whom esophageal biopsy would be contraindicated (eq. varices)

3) Subjects with serious infections requiring IV antibiotics

4) Subjects with known HIV or chronic viral hepatitis

5) Subjects on active chemotherapy or radiation treatment

6) Subjects who have had an esophagectomy

7) Subjects with an active malignancy diagnosed or treated within 3 years except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin; Carcinoma in situ, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy; Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery.

8) Subjects with pathologically confirmed history of Barrett's LGD within the last 12 months.

Links

Registration Number: NCT00844077
Study Information on Clinical Trials Registry (clinicaltrials.gov)