Status:
ACTIVE_NOT_RECRUITING
A Systems Approach to Immunotherapy Biomarker Identification Within the Postoperative Wound-Healing Microenvironment in Patients With Gastroesophageal Cancer
Lead Sponsor:
Inova Health Care Services
Collaborating Sponsors:
George Mason University
Conditions:
GastroEsophageal Cancer
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05338060
Start Date
January 26 2022
End Date
January 30 2026
Last Update
February 6 2025
Active Locations (1)
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1
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031