Know Cancer

or
forgot password

A Prospective Clinical Trial to Evaluate Mesothelin as a Biomarker for the Clinical Management of Esophageal Adenocarcinoma (EAC)


N/A
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer, Adenocarcinoma

Thank you

Trial Information

A Prospective Clinical Trial to Evaluate Mesothelin as a Biomarker for the Clinical Management of Esophageal Adenocarcinoma (EAC)


Inclusion Criteria:



- Patients with T1 adenocarcinoma or suspected adenocarcinoma who are scheduled for a
biopsy and mucosal resection (Group 1)

- Patients with a T1-2N0 adenocarcinoma or suspected adenocarcinoma who are scheduled
to undergo and esophagectomy (Group 2)

- Patients with T2N1 and T3N0-1 adenocarcinoma or suspected adenocarcinoma who are
scheduled to undergo endoscopy and biopsy and/or endoscopic ultrasound and biopsy
prior to pre-operative chemo-radiotherapy (Group 3)

Exclusion Criteria:

- Patients <18 years of age

- Patients unfit medically for endoscopy surveillance and therapy

- Patients unfit medically for esophagectomy

- Patients with stage IV esophageal adenocarcinoma

- Patients previously treated with chemo-radiotherapy for their esophageal cancer

- Patients with squamous cell carcinoma of the esophagus

- Patients who have a history of cancer within 3 years or have a concurrent cancer.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To evaluate prospectively what proportion of esophageal adenocarcinomas express tissue.

Outcome Description:

The investigators will examine the range and variability in the percentage on cells stained (for TM) and in the absolute value (for SM). TM expression is commonly analyzed in a binary fashion, with 25% of cells stained indicating positive expression (per standard pathological guidelines for tissue staining)

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Nabil Rizk, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-037

NCT ID:

NCT01393483

Start Date:

March 2011

Completion Date:

March 2015

Related Keywords:

  • Esophageal Cancer
  • Adenocarcinoma
  • esophagectomy
  • endoscopy
  • biopsy
  • Tissue mesothelin
  • Serum mesothelin
  • 11-037
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021