Evaluate Mesothelin as a Biomarker for the Clinical Management of Esophageal Adenocarcinoma (EAC)

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Esophageal Cancer; Adenocarcinoma

Treatments: Other: serum and tissue mesothelin

Study type: Observational

Funder types: Other

Identifiers

NCT01393483

11-037

Details and patient eligibility

About

The purpose of this study is to find out whether a protein, called mesothelin, found in the blood and tissue can be used as "marker" for esophageal cancer. Doctors at Memorial Sloan-Kettering Cancer Center would like to compare levels of this protein in patients with abnormal cells or tissue of the esophageal to the levels of this protein in patients being treated for cancer for the esophagus.

Enrollment: 371 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 and have baseline and surgical tissue available for staining (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.

Trial design

371 participants in 3 patient groups

patients endoscopically resected

Description:

In patients with endoscopically resected T1 disease (40 patients in 2 years) if available, we will stain the initial endoscopic tumor specimen, as well as any subsequent specimen obtained at each routine 3(+/- 2) month interval endoscopy.

Treatment:

Other: serum and tissue mesothelin

Other: serum and tissue mesothelin

Other: serum and tissue mesothelin

patients treated primarily with surgery

Description:

In patients who undergo surgery as their primary therapy, serum will be obtained at the time of surgical resection, and at each subsequent long-term disease status follow-up visit every 4 (+/- 2) months.

Treatment:

Other: serum and tissue mesothelin

Other: serum and tissue mesothelin

Other: serum and tissue mesothelin

patients who undergo chemo-radiation prior to surgery

Description:

a serum sample will be obtained : 1) prior to initiation of therapy, 2) following the completion of induction chemotherapy, 3) at the time of surgical resection, and 4) at each subsequent long-term disease status follow-up visit every 4 (+/- 2) months. The availability of tissue for staining will determine whether or not patients are evaluable for Group 3.

Treatment:

Other: serum and tissue mesothelin

Other: serum and tissue mesothelin

Other: serum and tissue mesothelin