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

GastroEsophageal Cancer Clinical Trial

— BAISIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05338060
• Other study ID #: U21-05-4450
• Status: Recruiting
• Start date: January 26, 2022
• Est. completion date: January 30, 2025

Study information

• Verified date: February 2024
• Source: Inova Health Care Services
• Contact: Keary Janet, BS
• Phone: 571-472-0224
• Email: keary.janet[@]inova.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• GastroEsophageal Cancer

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Inova Schar Cancer Institute	Fairfax	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Inova Health Care Services	George Mason University

Country where clinical trial is conducted

United States, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of a workflow for collection of SEs from esophageal and gastric cancer patients.	to establish a workflow for collection of SEs from patients affected by esophageal and gastric cancer undergoing surgical resection.	6 months
Secondary	Assay characterization of SEs for Predictive and Prognostic Biomarkers to early vs. late/non-recurrence of malignancy.	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