Clinical trial NCT05338060: A Systems Approach to Immunotherapy Biomarker Identification Within the Postoperative Wound-Healing Microenvironment in Patients With Gastroesophageal Cancer
Official title: A Systems Approach to Immunotherapy Biomarker Identification Within the Postoperative Wound-Healing Microenvironment in Patients With Gastroesophageal Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: GastroEsophageal Cancer
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: George Mason University
First posted: 2022-04-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult males and females at least 18 years of age undergoing esophagectomy or gastrectomy for gastroesophageal cancer

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Establishment of a workflow for collection of SEs from esophageal and gastric cancer patients.
timeFrame: 6 months
Secondary outcomes:
measure: Assay characterization of SEs for Predictive and Prognostic Biomarkers to early vs. late/non-recurrence of malignancy.
timeFrame: 24 months
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
Study officials:
affiliation: Inova Schar Cancer Institute
name: Raymond Wadlow, MD
role: PRINCIPAL_INVESTIGATOR
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