Status:
NOT_YET_RECRUITING
Multi-omics Monitoring of Dynamic Evolution in Esophageal Squamous Cell Carcinoma: PKU-ESCC-Monitor
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
Esophageal Squamous Cell Carcinoma (ESCC)
Eligibility:
All Genders
18-79 years
Brief Summary
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,...
Detailed Description
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 im...
Eligibility Criteria
Inclusion
- Peri-operative cohort:
- Age ≥18 and \<80 years; ECOG 0-1.
- Histologically confirmed ESCC.
- Completed standard neoadjuvant therapy and planned/underwent 4.transthoracic esophagectomy with routine surgical specimens available.
- Able to provide clinical course/outcomes and comply with follow-up at participating sites.
- Advanced first-line immunotherapy cohort:
- Age ≥18 and \<80 years; ECOG 0-1.
- Histologically confirmed ESCC, or highly suspected by endoscopy/imaging when surgery is not feasible.
- No prior systemic anti-cancer therapy for advanced disease; archived FFPE slides (3-5 µm, 5-8 slides) acceptable if fresh tissue unavailable.
- Able to provide clinical information and comply with follow-up.
Exclusion
- Prior anti-cancer therapy (except standard neoadjuvant therapy in the peri-operative cohort).
- Other malignancy within 5 years (exceptions: non-melanoma skin cancer, in-situ melanoma, in-situ cervical cancer).
- Inadequate clinical information.
- Known infection with HIV, HBV, HCV, or syphilis.
- Pre-operative imaging indicates insufficient tumor tissue (no visible target region) for study procedures.
- Any condition deemed by investigators to make the patient unsuitable.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT07152535
Start Date
September 1 2025
End Date
July 1 2028
Last Update
September 3 2025
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