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NCT Number: NCT01393483

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 2 years

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

    Time frame: 2 years

    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.

  3. To evaluate prospectively if clinical response to induction chemotherapy

    Time frame: 2 years

    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.

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

    Time frame: 2 years

    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

Secondary outcomes

  1. To evaluate whether expression of tissue mesothelin is a predictor of recurrence

    Time frame: 2 years

    The investigators will Wilcoxon test to investigate the association between serum mesothelin and tissue mesothelin at each time point where both markers are evaluated, and will further attempt to obtain an aggregate measure of this correlation using clustered Wilcoxon test, which accounts for multiple measurements per patient (14).

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

    Time frame: 2 years

    Mesothelin positive tumors (MES+) will be defined as strong staining in > 25% of the tumor cells and mesothelin negative tumors (MES-) are defined as <= 25% cytoplasmic staining. Serum mesothelin will be collected and analyzed, whenever possible, on a continuous scale.

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

    Time frame: 2 years

  4. To evaluate the correlation between serum mesothelin levels and tissue expression

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2024
Study completion
2024
First posted
Jul 13, 2011
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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