Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT07152535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-omics Monitoring of Dynamic Evolution in Esophageal Squamous Cell Carcinoma: PKU-ESCC-Monitor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor biopsy before neoadjuvant/first-line therapy; surgical specimens and adjacent tissue from transthoracic esophagectomy; archived FFPE slides (3-5 μm, 5-8 slides when fresh tissue is unavailable); serial blood for ctDNA and cytokines (e.g., IL-6/IL-8). All specimens are obtained from routine clinical care with consent and retained for DNA analyses.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 255}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-Free Survival (DFS)', 'timeFrame': 'up to 60 months', 'description': 'peri-operative cohort; time from study registration to first ESCC recurrence or death from any cause; patients alive without recurrence are censored at last contact.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'up to 36 months', 'description': 'advanced cohort;time from start of first-line therapy to first documented disease progression per RECIST 1.1 or death.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'up to 60 months', 'description': 'time from study registration to death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Time to Response (TTR)', 'timeFrame': 'up to 60 months', 'description': 'time from study registration to first ESCC recurrence or death from any cause; patients alive without recurrence are censored at last contact.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'best overall response up to 24 months; proportion with CR/PR by RECIST 1.1.', 'description': 'up to 24 months'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'up to 24 months; proportion with CR/PR/SD by RECIST 1.1.', 'description': 'up to 24 months'}, {'measure': 'Biomarker Analyses', 'timeFrame': 'baseline to 36-60 months', 'description': 'exploratory associations for PD-L1, HER2, EGFR, ctDNA dynamics, IL-6/IL-8 and other immune/microbiome markers with outcomes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ESCC', 'Multi-omics', 'ctDNA', 'Immunotherapy', 'Neoadjuvant Therapy', 'Prospective Cohort', 'Biomarkers'], 'conditions': ['Esophageal Squamous Cell Carcinoma (ESCC)']}, 'descriptionModule': {'briefSummary': 'This prospective observational study (PKU-ESCC-Monitor) aims to characterize the dynamic evolution of esophageal squamous cell carcinoma (ESCC) using integrated multi-omics, including tissue genomics, ctDNA, imaging features, immune profiling and microbiome. Two cohorts will be followed: a peri-operative cohort after standard neoadjuvant therapy and surgery, and an advanced cohort receiving first-line immunotherapy. Clinical outcomes (DFS/PFS/OS) and biomarker dynamics will be analyzed to improve risk stratification and response prediction.', 'detailedDescription': 'The study integrates clinical data with multi-omics (tumor tissue, surgical specimens, archived FFPE slides where applicable, serial blood for ctDNA and cytokines such as IL-6/IL-8, and exploratory immune/microbiome assessments). Patients are followed monthly or per routine visits up to 36-60 months. Analyses include RECIST 1.1-based responses (ORR, DCR, TTR, DOR), survival endpoints, and biomarker-clinical modeling to delineate ESCC evolutionary patterns and treatment response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults (18-79 years) with histologically confirmed esophageal squamous cell carcinoma (ESCC) treated at Peking University Cancer Hospital and participating centers in China. Two prospective cohorts: (1) peri-operative patients who complete standard neoadjuvant therapy and undergo transthoracic esophagectomy; (2) unresectable/advanced ESCC receiving standard-of-care first-line immunotherapy. ECOG 0-1. Tumor tissue (biopsy or surgical; archived FFPE slides acceptable if fresh tissue is unavailable) and serial blood are collected for multi-omics analyses. Key exclusions include prior systemic therapy for advanced disease (except neoadjuvant in the peri-operative cohort), other active malignancies within 5 years (allowing non-melanoma skin and in-situ cervical cancer), inadequate clinical information, or investigator-assessed unsuitability.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPeri-operative cohort:\n\n1. Age ≥18 and \\<80 years; ECOG 0-1.\n2. Histologically confirmed ESCC.\n3. Completed standard neoadjuvant therapy and planned/underwent 4.transthoracic esophagectomy with routine surgical specimens available.\n\n5.Able to provide clinical course/outcomes and comply with follow-up at participating sites.\n\nAdvanced first-line immunotherapy cohort:\n\n1. Age ≥18 and \\<80 years; ECOG 0-1.\n2. Histologically confirmed ESCC, or highly suspected by endoscopy/imaging when surgery is not feasible.\n3. No prior systemic anti-cancer therapy for advanced disease; archived FFPE slides (3-5 µm, 5-8 slides) acceptable if fresh tissue unavailable.\n4. Able to provide clinical information and comply with follow-up.\n\nExclusion Criteria:\n\n1. Prior anti-cancer therapy (except standard neoadjuvant therapy in the peri-operative cohort).\n2. Other malignancy within 5 years (exceptions: non-melanoma skin cancer, in-situ melanoma, in-situ cervical cancer).\n3. Inadequate clinical information.\n4. Known infection with HIV, HBV, HCV, or syphilis.\n5. Pre-operative imaging indicates insufficient tumor tissue (no visible target region) for study procedures.\n6. Any condition deemed by investigators to make the patient unsuitable.'}, 'identificationModule': {'nctId': 'NCT07152535', 'acronym': 'PKU-ESCC', 'briefTitle': 'Multi-omics Monitoring of Dynamic Evolution in Esophageal Squamous Cell Carcinoma: PKU-ESCC-Monitor', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'Multi-omics Monitoring of Dynamic Evolution in Esophageal Squamous Cell Carcinoma: PKU-ESCC-Monitor', 'orgStudyIdInfo': {'id': 'PKU-ESCC-0604'}, 'secondaryIdInfos': [{'id': 'LGH2025236', 'type': 'OTHER', 'domain': 'Peking University Cancer Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peri-operative ESCC Cohort', 'description': 'Patients with histologically confirmed ESCC who complete standard neoadjuvant therapy and undergo transthoracic esophagectomy. Study assigns no treatment; care is per treating physicians. Study procedures include collection of tumor tissue/surgical specimens or archived FFPE slides and serial blood for ctDNA/cytokines, plus prospective follow-up of clinical outcomes.'}, {'label': 'Advanced ESCC First-line Immunotherapy Cohort', 'description': 'Patients with unresectable/advanced ESCC receiving standard-of-care first-line immunotherapy at participating centers. No assigned intervention by the study; all treatments are per routine practice. Study procedures include tumor biopsy or archived FFPE slides and serial blood for ctDNA/cytokines, with prospective follow-up for responses and survival.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhihao Lu', 'role': 'CONTACT', 'email': 'pppeirain@126.com', 'phone': '+85201088196561'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}