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临床试验/NCT07597369
NCT07597369进行中(未招募)不适用

Expression Profiles And Prognostic Implications Of Clinically Actionable Tumor-Associated Antigens Across Diverse Clinicopathological Subtypes of Prostate Cancer: a Bidirectional Cohort Study

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,600
试验地点
1

研究概览

简要总结

The goal of this observational study is to evaluate and validate the expression and prognostic value of 15 ADC-targetable membrane proteins (PSMA, B7-H3, STEAP1, TROP2, KLK2, HER2, TF, HER3, DLL3, SEZ6, STEAP2, MUC1, NECTIN4, FAP, PDL1) in patients with diverse clinicopathological subtypes of prostate cancer (e.g. primary and different metastatic types,HSPC and CRPC, PC with neuroendocrine differentiation, cribriform/intraductal carcinoma).

The main questions it aims to answer are:

  1. What is the expression profile of 15 clinically actionable targes in tumor tissues from patients with diverse clinicopathological subtypes of prostate cancer?
  2. Can the prognostic value of these targets (e.g. association with overall survival) identified in a retrospective cohort be validated in an independent prospective cohort? Researchers will head-to-head compare the expression levels among different targets and across different disease stages/metastatic site. Researchers will also assess whether the targets showing prognostic significance in the retrospective cohort can also predict survival outcomes in the prospective cohort.

Participants in the retrospective cohort have already provided archived tissue samples and clinical data. Participants in the prospective cohort (metastatic prostate cancer patients) will be invited to provide residual tumor tissue samples obtained during standard care and will be followed up regularly for clinical outcomes.

详细描述

  1. Study Type This is a single-center, observational cohort study incorporating both retrospective and prospective components. It is a non-interventional study that does not involve assignment of participants to specific interventions.
  2. Objectives

Primary Objectives:

  1. To determine the protein expression profile (positive rate, expression level) of 15 membrane targets (PSMA, B7-H3, STEAP1, TROP2, KLK2, HER2, TF, HER3, DLL3, SEZ6, STEAP2, MUC1, NECTIN4, FAP, PDL1) in diverse clinicopathological subtypes of prostate cancer (HSPC and CRPC,primary and metastatic lesions include lymph node, bone and visceral metastasis, etc.).
  2. To characterize the molecular subtypes of prostate cancer based on the expression profiles of AR, PSA, PSMA, Syn, CgA, CD56, p53, RB1, and PTEN across different disease states and metastatic sites.
  3. To validate the association between the expression of prognostically significant targets (identified in the retrospective cohort) and overall survival (OS) in an independent, prospectively enrolled cohort of prostate cancer patients.

Secondary Objectives:

  1. To compare the expression of each target between matched CSPC and mCRPC samples from the same patients.
  2. To compare the expression of each target across different metastatic sites (e.g., bone, lymph node, viscera) in mCRPC.
  3. To analyze the association between target expression and clinical outcomes [biochemical recurrence-free survival (BFS), metastasis-free survival (MFS)] in patients with CSPC.
  4. To explore co-expression patterns of the targets and their correlation with clinicopathological features.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • For the Retrospective Cohorts (mCRPC, CSPC, Special Pathology):
  • Patients with a pathological diagnosis of prostate cancer.
  • Treated at Peking University First Hospital between January 2000 and
  • Availability of adequate, qualified formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks for research.
  • Availability of essential clinical and follow-up data in medical records.
  • For the Prospective Cohort:
  • Age ≥ 18 years.
  • CSPC, primarily includes patients who underwent neoadjuvant therapy and have paired pre- and post-treatment biopsy and surgical specimens; or patients with special clinicopathological subtypes.
  • metastatic prostate cancer patients.
  • Planned or recent (within 6 months prior to enrollment) acquisition of tumor tissue (from metastasis or primary site) as part of standard clinical care, with sufficient residual tissue available for the study.
  • Willing and able to provide written informed consent.

排除标准

  • For All Cohorts:
  • Tumor tissue sample is of insufficient quality or quantity for immunohistochemical (IHC) analysis.
  • Essential clinical or outcome data are missing or irretrievable, which would preclude meaningful analysis.
  • Specifically for the Prospective Cohort:
  • Any condition that, in the investigator's judgment, would significantly compromise the patient's ability to provide informed consent or comply with the study follow-up procedures.
  • Patient refusal to participate.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yelin Mulati

Chief Physician;Postdoctoral fellow

Peking University First Hospital

研究点 (1)

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