Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 12:49 PM
Study NCT ID:
NCT05338060
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-06
First Post:
2022-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Systems Approach to Immunotherapy Biomarker Identification Within the Postoperative Wound-Healing Microenvironment in Patients With Gastroesophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'we will collect six to eight milliliters of fluid from surgical drains placed by the surgeon at the time of surgery to assist with wound healing. Samples will be collected at one and four to six days after surgery. One tube of blood will also be collected at both time points. The research will not include whole genome sequencing.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2022-04-05', 'studyFirstSubmitQcDate': '2022-04-13', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}], 'secondaryOutcomes': [{'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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['GastroEsophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '28693793', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27938382', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28331612', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27532023', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29905002', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10655437', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22910898', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16641170', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24608425', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28502000', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12634793', 'type': 'BACKGROUND', 'citation': 'Aebersold R, Mann M. Mass spectrometry-based proteomics. Nature. 2003 Mar 13;422(6928):198-207. doi: 10.1038/nature01511.'}, {'pmid': '21228852', 'type': 'BACKGROUND', 'citation': 'Poste G. Bring on the biomarkers. Nature. 2011 Jan 13;469(7329):156-7. doi: 10.1038/469156a. No abstract available.'}, {'pmid': '18456800', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22639787', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20196732', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20549403', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '31432421', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31455798', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Popper U, Rumpold H. Update ESMO: gastric and esophageal cancer. memo - Magazine of European Medical Oncology. 2021;14:180-3.'}, {'pmid': '29880231', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '33026938', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '31582355', 'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': '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.'}, {'pmid': '33789008', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult males and females at least 18 years of age undergoing esophagectomy or gastrectomy for gastroesophageal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing esophagectomy or gastrectomy for gastroesophageal cancer.\n* Adult males and females at least 18 years of age\n* Ability to complete testing in the protocol and attend study visits\n* Able and willing to consent to protocol\n* 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\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breast-feeding\n* Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.\n* Life-threatening intercurrent illness\n* Anticipated poor compliance\n* Prisoners or subjects who are involuntarily incarcerated\n* Persons with decisional incapacity/cognitive impairment\n* 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\n* Subject is enrolled in a separate interventional clinical trial"}, 'identificationModule': {'nctId': 'NCT05338060', 'acronym': 'BAISIC', 'briefTitle': 'A Systems Approach to Immunotherapy Biomarker Identification Within the Postoperative Wound-Healing Microenvironment in Patients With Gastroesophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Inova Health Care Services'}, 'officialTitle': 'A Systems Approach to Immunotherapy Biomarker Identification Within the Postoperative Wound-Healing Microenvironment in Patients With Gastroesophageal Cancer', 'orgStudyIdInfo': {'id': 'U21-05-4450'}}, 'armsInterventionsModule': {'interventions': [{'name': 'prospective collection of surgical exudates (SEs)', 'type': 'OTHER', 'description': 'prospective collection of surgical exudates (SEs) from patients who are hospitalized for post-operative recovery from esophagectomy or gastrectomy for gastroesophageal cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Schar Cancer Institute', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'overallOfficials': [{'name': 'Raymond Wadlow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inova Schar Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inova Health Care Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'George Mason University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}