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OpenTrials
Completed

NCT Number: NCT05338060

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

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.

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Key information

Conditions

GastroEsophageal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prospective collection of surgical exudates (SEs)

Other

prospective collection of surgical exudates (SEs) from patients who are hospitalized for post-operative recovery from esophagectomy or gastrectomy for gastroesophageal cancer

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Collaborators

  • George Mason University

Registry information

Acronym: BAISIC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2022
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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