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NCT07152535Not yet recruiting

Multi-omics Monitoring of Dynamic Evolution in Esophageal Squamous Cell Carcinoma: PKU-ESCC-Monitor

Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
255 (estimated)
First submitted
26 Aug 2025
Start date
1 Sept 2025
Primary completion date
1 Jul 2027
Lead sponsor
Peking University Cancer Hospital & Institute
NCT number
NCT07152535

What you commit to

  • Study type: Observational
  • Planned participants: 255
  • From 1 Sept 2025 to the primary completion date, 1 Jul 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior anti-cancer therapy (except standard neoadjuvant therapy in the peri-operative cohort).

Other illness

  • Other malignancy within 5 years (exceptions: non-melanoma skin cancer, in-situ melanoma, in-situ cervical cancer).
  • Known infection with HIV, HBV, HCV, or syphilis.
  • Any condition deemed by investigators to make the patient unsuitable.

Other

  • Inadequate clinical information.
  • Pre-operative imaging indicates insufficient tumor tissue (no visible target region) for study procedures.

Who the study is looking for

  • 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.
    • 5.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.

Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.