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

NCT ID: NCT01393483

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 371 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2024-10-22

Brief Summary

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.

Conditions

Esophageal Cancer; Adenocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients endoscopically resected

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.

serum and tissue mesothelin

Intervention Type: OTHER

Tissue mesothelin staining at the time of the initial endoscopy, and of any subsequent biopsy specimen during the endoscopic screening period.

Serum mesothelin level at the time of initial endoscopy, and at each subsequent endoscopy for two years or until disease recurs.

patients treated primarily with surgery

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.

serum and tissue mesothelin

Intervention Type: OTHER

Tissue mesothelin staining on the surgically resected esophageal specimen. Serum mesothelin level at the time of surgical resection, and at each follow-up clinic visit for two years or until disease recurs.

patients who undergo chemo-radiation prior to surgery

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.

serum and tissue mesothelin

Intervention Type: OTHER

Tissue mesothelin staining on the initial endoscopic specimen (typically obtained when an EUS is done) and on the surgically resected esophageal specimen Serum mesothelin level prior to initiation of induction chemotherapy, at the time of the post-induction PET, at the time of surgical resection, and at each follow-up clinic visit for two years or until disease recurs.

Interventions

serum and tissue mesothelin

Tissue mesothelin staining at the time of the initial endoscopy, and of any subsequent biopsy specimen during the endoscopic screening period.

Serum mesothelin level at the time of initial endoscopy, and at each subsequent endoscopy for two years or until disease recurs.

Intervention Type: OTHER

serum and tissue mesothelin

Tissue mesothelin staining on the surgically resected esophageal specimen. Serum mesothelin level at the time of surgical resection, and at each follow-up clinic visit for two years or until disease recurs.

Intervention Type: OTHER

serum and tissue mesothelin

Tissue mesothelin staining on the initial endoscopic specimen (typically obtained when an EUS is done) and on the surgically resected esophageal specimen Serum mesothelin level prior to initiation of induction chemotherapy, at the time of the post-induction PET, at the time of surgical resection, and at each follow-up clinic visit for two years or until disease recurs.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prasad Adusumilli, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

References

Rizk NP, Servais EL, Tang LH, Sima CS, Gerdes H, Fleisher M, Rusch VW, Adusumilli PS. Tissue and serum mesothelin are potential markers of neoplastic progression in Barrett's associated esophageal adenocarcinoma. Cancer Epidemiol Biomarkers Prev. 2012 Mar;21(3):482-6. doi: 10.1158/1055-9965.EPI-11-0993. Epub 2012 Jan 11.

Reference Type: DERIVED

PMID: 22237988 (View on PubMed)

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

11-037

Identifier Type: -

Identifier Source: org_study_id