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

NCT01393483 | Completed

• 1 other identifier: 11-037
• Study Type: observational
• Target: 371
• Locations: 1 country
• Sites: 1

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

Keywords

esophagectomy; endoscopy; biopsy; Tissue mesothelin; Serum mesothelin; 11-037

Outcome Measures

Primary Outcomes (4)

• To evaluate prospectively what proportion of esophageal adenocarcinomas express tissue.

  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)

  2 years

• To evaluate prospectively if serum mesothelin levels correlate to clinical stage in esophageal adenocarcinomas

  The investigators will explore the optimal cut point that defines positive expression. Serum mesothelin (SM) will be measured and analyzed whenever possible on a continuous scale.

  2 years

• To evaluate prospectively if clinical response to induction chemotherapy

  First, the investigators will use two-sample t-tests to determine whether the initial responders to induction chemotherapy (defined as \>30% decrease in SUV at the repeat PET) differ from non-responders in their 1) baseline (pre-induction) SM value, and 2) percent change in SM value between pre-induction and mid-induction (after 2 cycles) evaluations.

  2 years

• To evaluate prospectively if clinical response to concurrent chemo-radiation correlates to serum mesothelin levels

  The investigators will take the following steps in order to assess the ability of SM at the time of resection with curative intent to predict disease recurrence: 1) we will examine the association between SM and the risk of recurrence by fitting a Cox proportional hazards model (after appropriate transformation of the SM value and checking of the PH assumption

  2 years

Secondary Outcomes (4)

• To evaluate whether expression of tissue mesothelin is a predictor of recurrence

  2 years

• To evaluate whether expression of tissue mesothelin is a predictor of poor response to chemotherapy

  2 years

• To evaluate for the presence of any confounders in the putative association between serum mesothelin expression and the risk of recurrence

  2 years

• To evaluate the correlation between serum mesothelin levels and tissue expression

  2 years

Study Arms (3)

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.

Other: serum and tissue mesothelin

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.

Other: serum and tissue mesothelin

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.

Other: serum and tissue mesothelin

Interventions

serum and tissue mesothelin 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 endoscopically resected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient seen in the gastroenterology and thoracic clinics who fits the inclusion criteria will be approached by the treating physician, the protocol investigator, or thoracic research team at Memorial Sloan-Kettering Cancer Center (MSKCC

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 22237988 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITHOUT DNA

tissue and serum

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Prasad Adusumilli, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 13, 2011
• Study Start: March 1, 2011
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

US (1)