Clinical trial · Observational
A Systems Approach to Immunotherapy Biomarker Identification Within the Postoperative Wound-Healing Microenvironment in Patients With Gastroesophageal Cancer
NCT05338060CI-TRIAL-00102986BAISICcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GastroEsophageal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prospective collection of surgical exudates (SEs) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Establishment of a workflow for collection of SEs from esophageal and gastric cancer patients.
- timeFrame
- 6 months
- description
- to establish a workflow for collection of SEs from patients affected by esophageal and gastric cancer undergoing surgical resection.
Secondary outcomes (1)
- measure
- Assay characterization of SEs for Predictive and Prognostic Biomarkers to early vs. late/non-recurrence of malignancy.
- timeFrame
- 24 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (25)
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- BACKGROUNDDholaria B, Hammond W, Shreders A, Lou Y. Emerging therapeutic agents for lung cancer. J Hematol Oncol. 2016 Dec 9;9(1):138. doi: 10.1186/s13045-016-0365-z. PMID 27938382
- BACKGROUNDDiggs LP, Hsueh EC. Utility of PD-L1 immunohistochemistry assays for predicting PD-1/PD-L1 inhibitor response. Biomark Res. 2017 Mar 15;5:12. doi: 10.1186/s40364-017-0093-8. eCollection 2017. PMID 28331612
- BACKGROUNDGrigg C, Rizvi NA. PD-L1 biomarker testing for non-small cell lung cancer: truth or fiction? J Immunother Cancer. 2016 Aug 16;4:48. doi: 10.1186/s40425-016-0153-x. eCollection 2016. PMID 27532023
- BACKGROUNDSundaram GM, Quah S, Sampath P. Cancer: the dark side of wound healing. FEBS J. 2018 Dec;285(24):4516-4534. doi: 10.1111/febs.14586. Epub 2018 Jun 25. PMID 29905002
- BACKGROUNDTherasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205. PMID 10655437
- BACKGROUNDFuse N, Nagahisa-Oku E, Doi T, Sasaki T, Nomura S, Kojima T, Yano T, Tahara M, Yoshino T, Ohtsu A. Effect of RECIST revision on classification of target lesions and overall response in advanced gastric cancer patients. Gastric Cancer. 2013 Jul;16(3):324-8. doi: 10.1007/s10120-012-0187-9. Epub 2012 Aug 22.