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

NCT ID: NCT05338060

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-26
• Study Completion Date: 2026-01-30

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.

Conditions

GastroEsophageal Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

George Mason University

OTHER

Sponsor Role: collaborator

Inova Health Care Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond Wadlow, MD

Role: PRINCIPAL_INVESTIGATOR

Inova Schar Cancer Institute

Locations

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Countries

United States

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Other Identifiers

U21-05-4450

Identifier Type: -

Identifier Source: org_study_id