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CompletedNCT05338060BAISICUpdated Feb 11, 2026

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

An observational study in GastroEsophageal Cancer, sponsored by Inova Health Care Services. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Inova Health Care Services · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • GastroEsophageal Cancer
03

In context

Lead sponsor

Inova Health Care Services is the lead sponsor of 84 studies on the registry; 20 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult males and females at least 18 years of age undergoing esophagectomy or gastrectomy for gastroesophageal cancer

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Otherprospective 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 24 months

07

Study locations

1 site
  • Inova Schar Cancer Institute
    Fairfax, Virginia 22031, United States
08

References and documents

Publications

  • Maleki Vareki S, Garrigos C, Duran I. Biomarkers of response to PD-1/PD-L1 inhibition. Crit Rev Oncol Hematol. 2017 Aug;116:116-124. doi: 10.1016/j.critrevonc.2017.06.001. Epub 2017 Jun 9. PubMed 28693793 ↗
  • Dholaria 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. PubMed 27938382 ↗
  • Diggs 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. PubMed 28331612 ↗
  • Grigg 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. PubMed 27532023 ↗
  • Sundaram 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. PubMed 29905002 ↗
  • Therasse 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. PubMed 10655437 ↗
  • Fuse 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. PubMed 22910898 ↗
  • Schwartz LH, Colville JA, Ginsberg MS, Wang L, Mazumdar M, Kalaigian J, Hricak H, Ilson D, Schwartz GK. Measuring tumor response and shape change on CT: esophageal cancer as a paradigm. Ann Oncol. 2006 Jun;17(6):1018-23. doi: 10.1093/annonc/mdl058. Epub 2006 Apr 26. PubMed 16641170 ↗
  • Pierobon M, Wulfkuhle J, Liotta L, Petricoin E. Application of molecular technologies for phosphoproteomic analysis of clinical samples. Oncogene. 2015 Feb 12;34(7):805-14. doi: 10.1038/onc.2014.16. Epub 2014 Mar 10. PubMed 24608425 ↗
  • Baldelli E, Calvert V, Hodge A, VanMeter A, Petricoin EF 3rd, Pierobon M. Reverse Phase Protein Microarrays. Methods Mol Biol. 2017;1606:149-169. doi: 10.1007/978-1-4939-6990-6_11. PubMed 28502000 ↗
  • Aebersold R, Mann M. Mass spectrometry-based proteomics. Nature. 2003 Mar 13;422(6928):198-207. doi: 10.1038/nature01511. PubMed 12634793 ↗
  • Poste G. Bring on the biomarkers. Nature. 2011 Jan 13;469(7329):156-7. doi: 10.1038/469156a. No abstract available. PubMed 21228852 ↗
  • Gerszten RE, Accurso F, Bernard GR, Caprioli RM, Klee EW, Klee GG, Kullo I, Laguna TA, Roth FP, Sabatine M, Srinivas P, Wang TJ, Ware LB. Challenges in translating plasma proteomics from bench to bedside: update from the NHLBI Clinical Proteomics Programs. Am J Physiol Lung Cell Mol Physiol. 2008 Jul;295(1):L16-22. doi: 10.1152/ajplung.00044.2008. Epub 2008 May 2. PubMed 18456800 ↗
  • Prakash A, Rezai T, Krastins B, Sarracino D, Athanas M, Russo P, Zhang H, Tian Y, Li Y, Kulasingam V, Drabovich A, Smith CR, Batruch I, Oran PE, Fredolini C, Luchini A, Liotta L, Petricoin E, Diamandis EP, Chan DW, Nelson R, Lopez MF. Interlaboratory reproducibility of selective reaction monitoring assays using multiple upfront analyte enrichment strategies. J Proteome Res. 2012 Aug 3;11(8):3986-95. doi: 10.1021/pr300014s. Epub 2012 Jul 3. PubMed 22639787 ↗
  • Luchini A, Fredolini C, Espina BH, Meani F, Reeder A, Rucker S, Petricoin EF 3rd, Liotta LA. Nanoparticle technology: addressing the fundamental roadblocks to protein biomarker discovery. Curr Mol Med. 2010 Mar;10(2):133-41. doi: 10.2174/156652410790963268. PubMed 20196732 ↗
  • Fredolini C, Meani F, Luchini A, Zhou W, Russo P, Ross M, Patanarut A, Tamburro D, Gambara G, Ornstein D, Odicino F, Ragnoli M, Ravaggi A, Novelli F, Collura D, D'Urso L, Muto G, Belluco C, Pecorelli S, Liotta L, Petricoin EF 3rd. Investigation of the ovarian and prostate cancer peptidome for candidate early detection markers using a novel nanoparticle biomarker capture technology. AAPS J. 2010 Dec;12(4):504-18. doi: 10.1208/s12248-010-9211-3. Epub 2010 Jun 12. PubMed 20549403 ↗
  • Pin E, Sjoberg R, Andersson E, Hellstrom C, Olofsson J, Jernbom Falk A, Bergstrom S, Remnestal J, Just D, Nilsson P, Manberg A. Array-Based Profiling of Proteins and Autoantibody Repertoires in CSF. Methods Mol Biol. 2019;2044:303-318. doi: 10.1007/978-1-4939-9706-0_19. PubMed 31432421 ↗
  • Park CH, Lee JG, Lee AR, Eun CS, Han DS. Network construction of gastric microbiome and organization of microbial modules associated with gastric carcinogenesis. Sci Rep. 2019 Aug 27;9(1):12444. doi: 10.1038/s41598-019-48925-4. PubMed 31455798 ↗
  • Popper U, Rumpold H. Update ESMO: gastric and esophageal cancer. memo - Magazine of European Medical Oncology. 2021;14:180-3.
  • Shitara K, Ozguroglu M, Bang YJ, Di Bartolomeo M, Mandala M, Ryu MH, Fornaro L, Olesinski T, Caglevic C, Chung HC, Muro K, Goekkurt E, Mansoor W, McDermott RS, Shacham-Shmueli E, Chen X, Mayo C, Kang SP, Ohtsu A, Fuchs CS; KEYNOTE-061 investigators. Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial. Lancet. 2018 Jul 14;392(10142):123-133. doi: 10.1016/S0140-6736(18)31257-1. Epub 2018 Jun 4. PubMed 29880231 ↗
  • Kojima T, Shah MA, Muro K, Francois E, Adenis A, Hsu CH, Doi T, Moriwaki T, Kim SB, Lee SH, Bennouna J, Kato K, Shen L, Enzinger P, Qin SK, Ferreira P, Chen J, Girotto G, de la Fouchardiere C, Senellart H, Al-Rajabi R, Lordick F, Wang R, Suryawanshi S, Bhagia P, Kang SP, Metges JP; KEYNOTE-181 Investigators. Randomized Phase III KEYNOTE-181 Study of Pembrolizumab Versus Chemotherapy in Advanced Esophageal Cancer. J Clin Oncol. 2020 Dec 10;38(35):4138-4148. doi: 10.1200/JCO.20.01888. Epub 2020 Oct 7. PubMed 33026938 ↗
  • Kato K, Cho BC, Takahashi M, Okada M, Lin CY, Chin K, Kadowaki S, Ahn MJ, Hamamoto Y, Doki Y, Yen CC, Kubota Y, Kim SB, Hsu CH, Holtved E, Xynos I, Kodani M, Kitagawa Y. Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Nov;20(11):1506-1517. doi: 10.1016/S1470-2045(19)30626-6. Epub 2019 Sep 30. PubMed 31582355 ↗
  • Moehler M, Shitara K, Garrido M, Salman P, Shen L, Wyrwicz L, et al. LBA6_PR Nivolumab (nivo) plus chemotherapy (chemo) versus chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcinoma (EAC): First results of the CheckMate 649 study. Annals of Oncology. 2020;31:S1191.
  • Kato K, Sun JM, Shah MA, Enzinger PC, Adenis A, Doi T, et al. LBA8_PR Pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase 3 KEYNOTE-590 study. Annals of Oncology. 2020;31:S1192-S3.
  • Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lievre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. doi: 10.1056/NEJMoa2032125. PubMed 33789008 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05338060
Lead sponsor
Inova Health Care Services
Collaborators
George Mason University
Responsible party
Sponsor
First posted
Apr 20, 2022
Start date
Jan 26, 2022
Primary completion
Aug 5, 2025
Completion
Aug 5, 2025
Last update
Feb 11, 2026

Study contacts

Raymond Wadlow, MD
principal investigator · Inova Schar Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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