AzTrials
AzTrials

GastroEsophageal CancerBAISICNCT05338060

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

An observational study of GastroEsophageal Cancer, run by Inova Health Care Services at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
GastroEsophageal Cancer
What is being tested?
prospective collection of surgical exudates (SEs)
How many people
10 participants
Where
1 siteUnited States
Study dates
26 Jan 2022to 5 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

Other trials in United States

About this study

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.

Being tested
prospective collection of surgical exudates (SEs)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • prospective collection of surgical exudates (SEs)Other

    prospective collection of surgical exudates (SEs) from patients who are hospitalized for post-operative recovery from esophagectomy or gastrectomy for gastroesophageal cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (1)

  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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start26 Jan 2022
  3. Primary completion5 Aug 2025
  4. Study completion5 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05338060
Sponsor's protocol ID
U21-05-4450
Acronym
BAISIC
Status last verified
Feb 2026
First submitted
5 Apr 2022
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of GastroEsophageal Cancer, run by Inova Health Care Services at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Establishment of a workflow for collection of SEs from esophageal and gastric cancer patients. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05338060, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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