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

Active, not recruiting

• Conditions: GastroEsophageal Cancer

• Registration Number: NCT05338060
• Lead Sponsor: Inova Health Care Services

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-26
• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-12-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establishment of a workflow for collection of SEs from esophageal and gastric cancer patients.	6 months	to establish a workflow for collection of SEs from patients affected by esophageal and gastric cancer undergoing surgical resection.

Secondary Outcome Measures

Name	Time	Method
Assay characterization of SEs for Predictive and Prognostic Biomarkers to early vs. late/non-recurrence of malignancy.	24 months	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.

Trial Locations

Locations (1)

Inova Schar Cancer Institute; 🇺🇸 Fairfax, Virginia, United States