A Systems Approach to Immunotherapy Biomarker Identification Within the Postoperative Wound-Healing Microenvironment in Patients With Gastroesophageal Cancer

Study Overview
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Brief Summary
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The purpose of this research is to collect surgical drain fluid and blood from patients who have undergone surgery for gastric or esophageal cancer, and to analyze the fluid and blood using a variety of laboratory techniques for molecular markers capable of predicting response to immunotherapy.

Official Title
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A Systems Approach to Immunotherapy Biomarker Identification Within the Postoperative Wound-Healing Microenvironment in Patients With Gastroesophageal Cancer

Conditions
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GastroEsophageal Cancer

Intervention / Treatment
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* Other: prospective collection of surgical exudates (SEs)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing esophagectomy or gastrectomy for gastroesophageal cancer. Adult males and females at least 18 years of age Ability to complete testing in the protocol and attend study visits Able and willing to consent to protocol Adequate organ function Absolute Neutrophil Count (ANC) ≥1.5 x 103/μL Platelets ≥100 x 103/μL Hemoglobin >9.0 g/dL Total Bilirubin (</= 2.0 mg/dl at time of Y90 radioembolization) AST/ALT ≤5 x upper limit of normal Albumin >3 g/dL Creatinine ≤1.5 mg/dL Exclusion Criteria: Female patients who are pregnant or breast-feeding Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants. Life-threatening intercurrent illness Anticipated poor compliance Prisoners or subjects who are involuntarily incarcerated Persons with decisional incapacity/cognitive impairment Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator unsuitable for the study Subject is enrolled in a separate interventional clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: prospective collection of surgical exudates (SEs)|prospective collection of surgical exudates (SEs) from patients who are hospitalized for post-operative recovery from esophagectomy or gastrectomy for gastroesophageal cancer|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishment of a workflow for collection of SEs from esophageal and gastric cancer patients. | to establish a workflow for collection of SEs from patients affected by esophageal and gastric cancer undergoing surgical resection. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assay characterization of SEs for Predictive and Prognostic Biomarkers to early vs. late/non-recurrence of malignancy. | SEs will be collected and characterized using different assays with the goal of generating hypotheses of potential predictive and prognostic biomarkers to early (<6 months) vs. late/non-recurrence of malignancy. | 24 months |