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Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus Progression to Dysplasia and Adenocarcinoma


N/A
18 Years
80 Years
Not Enrolling
Both
Barrett's Esophagus

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Trial Information

Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus Progression to Dysplasia and Adenocarcinoma


Inclusion Criteria:



- Adults (> 18 years old)

- Subjects with pathologically confirmed Barrett's esophagus, including:

- Intestinal metaplasia without dysplasia, long and short segments (>1 cm)

- Intestinal metaplasia without dysplasia, long and short segments (>1 cm), previously
in GLNE 003

- Intestinal metaplasia without dysplasia with indefinite-for-dysplasia (or history of
indefinite-for-dysplasia) provided there is no history of HGD, or EAC.

- 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.

- Able to physically tolerate removal of 34 ml of blood

- Tolerate extra research related biopsies and brushings

- Willing to permit extra biopsies at future endoscopic procedures

- Ability and willingness to complete questionnaires

- Willing to sign informed consent Exclusion Criteria

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

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

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

- Subjects with serious infections requiring IV antibiotics

- Subjects with known HIV or chronic viral hepatitis

- Subjects on active chemotherapy or radiation treatment

- Subjects who have had an esophagectomy

- 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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Conversion from Barrett's intestinal metaplasia to dysplasia or esophageal adenocarcinoma.

Outcome Time Frame:

5-8 years

Safety Issue:

No

Principal Investigator

Dean E Brenner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Institutional Review Board

Study ID:

GLNE 008

NCT ID:

NCT00844077

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Barrett's Esophagus
  • Barrett's Intestinal Metaplasia
  • Barrett Esophagus

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
MD Anderson Cancer CenterHouston, Texas  77030-4096
Columbia UniversityNew York, New York  10032-3784
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Mt. Sinai School of MedicineNew York, New York  10029