Clinical trial NCT01393483: Evaluate Mesothelin as a Biomarker for the Clinical Management of Esophageal Adenocarcinoma (EAC)
Official title: A Prospective Clinical Trial to Evaluate Mesothelin as a Biomarker for the Clinical Management of Esophageal Adenocarcinoma (EAC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Adenocarcinoma
Keywords: esophagectomy
endoscopy
biopsy
Tissue mesothelin
Serum mesothelin
11-037
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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.

Primary outcomes:
measure: To evaluate prospectively what proportion of esophageal adenocarcinomas express tissue.
timeFrame: 2 years
measure: To evaluate prospectively if serum mesothelin levels correlate to clinical stage in esophageal adenocarcinomas
timeFrame: 2 years
measure: To evaluate prospectively if clinical response to induction chemotherapy
timeFrame: 2 years
measure: To evaluate prospectively if clinical response to concurrent chemo-radiation correlates to serum mesothelin levels
timeFrame: 2 years
Secondary outcomes:
measure: To evaluate whether expression of tissue mesothelin is a predictor of recurrence
timeFrame: 2 years
measure: To evaluate whether expression of tissue mesothelin is a predictor of poor response to chemotherapy
timeFrame: 2 years
measure: To evaluate for the presence of any confounders in the putative association between serum mesothelin expression and the risk of recurrence
timeFrame: 2 years
measure: To evaluate the correlation between serum mesothelin levels and tissue expression
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Prasad Adusumilli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.