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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate whether expression of tissue mesothelin is a predictor of recurrence | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Prasad Adusumilli, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22237988 | Derived | 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. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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tissue and serum
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| serum and tissue mesothelin | 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. |
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| serum and tissue mesothelin | 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. |
|
| 2 years |
| To evaluate whether expression of tissue mesothelin is a predictor of poor response to chemotherapy | 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. | 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 |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |