Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-26 @ 9:37 AM
Study NCT ID:
NCT06476067
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2024-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
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Integrated multi-omics profiling yields a clinically relevant molecular classification for esophageal squamous cell carcinoma. Cancer Cell. 2023 Jan 9;41(1):181-195.e9. doi: 10.1016/j.ccell.2022.12.004. Epub 2022 Dec 29.'}, {'pmid': '31711920', 'type': 'BACKGROUND', 'citation': 'Azad TD, Chaudhuri AA, Fang P, Qiao Y, Esfahani MS, Chabon JJ, Hamilton EG, Yang YD, Lovejoy A, Newman AM, Kurtz DM, Jin M, Schroers-Martin J, Stehr H, Liu CL, Hui AB, Patel V, Maru D, Lin SH, Alizadeh AA, Diehn M. Circulating Tumor DNA Analysis for Detection of Minimal Residual Disease After Chemoradiotherapy for Localized Esophageal Cancer. Gastroenterology. 2020 Feb;158(3):494-505.e6. doi: 10.1053/j.gastro.2019.10.039. Epub 2019 Nov 9.'}, {'pmid': '34465601', 'type': 'BACKGROUND', 'citation': 'Kandimalla R, Xu J, Link A, Matsuyama T, Yamamura K, Parker MI, Uetake H, Balaguer F, Borazanci E, Tsai S, Evans D, Meltzer SJ, Baba H, Brand R, Von Hoff D, Li W, Goel A. 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Surgically Resected Esophageal Squamous Cell Carcinoma: Patient Survival and Clinicopathological Prognostic Factors. Sci Rep. 2020 Mar 19;10(1):5077. doi: 10.1038/s41598-020-62028-5.'}, {'pmid': '27507904', 'type': 'BACKGROUND', 'citation': 'Jang HJ, Lee HS, Burt BM, Lee GK, Yoon KA, Park YY, Sohn BH, Kim SB, Kim MS, Lee JM, Joo J, Kim SC, Yun JS, Na KJ, Choi YL, Park JL, Kim SY, Lee YS, Han L, Liang H, Mak D, Burks JK, Zo JI, Sugarbaker DJ, Shim YM, Lee JS. Integrated genomic analysis of recurrence-associated small non-coding RNAs in oesophageal cancer. Gut. 2017 Feb;66(2):215-225. doi: 10.1136/gutjnl-2015-311238. Epub 2016 Aug 9.'}, {'pmid': '18697202', 'type': 'BACKGROUND', 'citation': 'Lee EJ, Lee BB, Han J, Cho EY, Shim YM, Park J, Kim DH. CpG island hypermethylation of E-cadherin (CDH1) and integrin alpha4 is associated with recurrence of early stage esophageal squamous cell carcinoma. Int J Cancer. 2008 Nov 1;123(9):2073-9. doi: 10.1002/ijc.23598.'}]}, 'descriptionModule': {'briefSummary': 'The prognosis of patients with esophageal squamous cell carcinoma (ESCC) who develop post-operative early tumor recurrence is often relatively poor. Therefore, biomarker that can detect micro metastases before the start of treatment is required. Epigenomic alterations such as DNA methylation have attracted attention as promising biomarkers. The investigators aim to predict early recurrence based on whole genome DNA methylation analysis of esophageal cancer.', 'detailedDescription': "Prognosis for patients with esophageal squamous cell carcinoma (ESCC) remains poor. Surgery is one of the standard treatments for patients with ESCC who are considered to have a curative resection, however, approximately 40% of patients develop tumor recurrence within two years after surgery. The main cause of poor prognosis in ESCC patients undergoing surgery is postoperative tumor recurrence due to the presence of latent micro-metastases at the time of surgery. Even with today's advances in preoperative diagnostic techniques, predicting early tumor recurrence remains difficult due to the lack of established methods. Epigenetic markers, especially DNA methylation, are considered ideal markers for predicting cancer metastasis due to their cancer-specific methylation patterns, biological stability, and technical reproducibility. Our study aims to evaluate methylation of surgical specimens to assess residual disease and predict early recurrence."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had undergone complete esophagectomy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who had histologically confirmed ESCC.\n2. Patients who had undergone only complete esophagectomy with radical lymph node dissection without chemotherapy or radiotherapy before or after surgery.\n3. Patients for whom tissue samples are available\n4. Patients who were followed-up completely, with information on observation periods of at least 2 years after surgery.\n5. Written informed consent following full study information is provided to the patient.\n\nExclusion Criteria:\n\n1. Patients lacking clinical information within 2 years of surgery.\n2. Patients with multiple cancers.'}, 'identificationModule': {'nctId': 'NCT06476067', 'briefTitle': 'Predicting Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Predicting Postoperative Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': '23228/ESCC-Erec'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with postoperative early tumor recurrence with ESCC （Training)', 'description': 'Patients with early tumor recurrence defined as patients who developed tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)', 'interventionNames': ['Procedure: Surgery']}, {'label': 'Patients without postoperative early tumor recurrence with ESCC （Training)', 'description': 'Patients without early tumor recurrence defined as patients who did not develope tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)', 'interventionNames': ['Procedure: Surgery']}, {'label': 'Patients with postoperative early tumor recurrence with ESCC （Validation)', 'description': 'Patients with early tumor recurrence defined as patients who developed tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)', 'interventionNames': ['Procedure: Surgery']}, {'label': 'Patients without postoperative early tumor recurrence with ESCC （Validation)', 'description': 'Patients without early tumor recurrence defined as patients who did not develope tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)', 'interventionNames': ['Procedure: Surgery']}], 'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Esophagectomy', 'armGroupLabels': ['Patients with postoperative early tumor recurrence with ESCC （Training)', 'Patients with postoperative early tumor recurrence with ESCC （Validation)', 'Patients without postoperative early tumor recurrence with ESCC （Training)', 'Patients without postoperative early tumor recurrence with ESCC （Validation)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4668560', 'city': 'Nagoya', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Fuminori Sonohara, PhD', 'role': 'CONTACT', 'email': 'Fuminori.sonohara@bswhealth.org'}], 'facility': 'Nagoya University', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '4093898', 'city': 'Chūō', 'state': 'Yamanashi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Katsutoshi Shoda, PhD', 'role': 'CONTACT', 'email': 'kshoda@yamanashi.ac.jp'}], 'facility': 'Yamanashi Universiy', 'geoPoint': {'lat': 35.59465, 'lon': 138.50275}}], 'centralContacts': [{'name': 'Ajay Goel, PhD', 'role': 'CONTACT', 'email': 'AJGOEL@COH.ORG', 'phone': '6262183452'}, {'name': 'Koichi Takiguchi, PhD', 'role': 'CONTACT', 'email': 'ktakiguchi@coh.org', 'phone': '6262183452'}], 'overallOfficials': [{'name': 'Koichi Takiguchi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}