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

February 9, 2026 updated by: Inova Health Care Services
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult males and females at least 18 years of age undergoing esophagectomy or gastrectomy for gastroesophageal cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establishment of a workflow for collection of SEs from esophageal and gastric cancer patients.
Time Frame: 6 months
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.
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Collaborators

George Mason University

Investigators

  • Principal Investigator: Raymond Wadlow, MD, Inova Schar Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2022

Primary Completion (Actual)

August 5, 2025

Study Completion (Actual)

August 5, 2025

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • U21-05-4450

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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