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Circulating Tumor DNA (ctDNA) Monitoring in the Assessment and Prediction of the Efficacy of PARP Inhibitors (PARPi)

2021年11月1日 更新者:Yonghong Li、Sun Yat-sen University
To evaluate the application value of customized ctDNA monitoring in efficacy assessment and prediction during PARPi treatment

研究概览

地位

招聘中

详细说明

This clinical study is an open-label, single-center, observational study to evaluate the application value of customized ctDNA monitoring in efficacy assessment and prediction during PARPi treatment in mCRPC patients. A total of 30 participants with second-line treatment failure will be registered in this study. Whole blood collection will be conducted during the treatment for ctDNA detection, homologous recombination repair (HRR) genes testing, personalized panel customization and whole exome sequencing.

研究类型

观察性的

注册 (预期的)

30

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Guangdong
      • Guangzhou、Guangdong、中国、510060
        • 招聘中
        • Sun Yat-Sen University Cancer Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

男性

取样方法

概率样本

研究人群

clinic-based sample

描述

Inclusion Criteria:

Patients must meet ALL of the following criteria:

  1. Willing and able to provide informed consent.
  2. Adult males from 18 to 75 years age.
  3. History of histologically or cytologically confirmed adenocarcinoma of the prostate with DDR genes mutation (BRCA1/2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L) detected by high throughput sequencing
  4. Documented evidence of metastatic castration resistant prostate cancer (mCRPC) and proposed treatment of PARP inhibitors.
  5. Evidence of measurable target lesion in imaging studies.
  6. Participants can provide adequate formalin fixed paraffin-embedded (FFPE) tumor tissue collected before any treatment: tumor cell content>30% and necrotic cells<10%.
  7. ECOG performance status 0-1
  8. Estimated survival≥12 weeks

Exclusion Criteria:

Patients must NOT meet any of the following criteria:

  1. Do not meet the inclusion criteria.
  2. Under any other anti-tumor therapy like chemotherapy and/or immunotherapy.
  3. Receiving organ transplantation in the last 3 months.
  4. Participants with autoimmune diseases or history of HBV, HCV or HIV infection (acute or chronic).
  5. Participants with pneumonia.
  6. Severe concurrent illness or co-morbid disease that would make the subject unsuitable for enrolment
  7. Unwilling and unable to provide informed consent.
  8. Patients who are judged unsuitable for clinical trial participation by the investigators.

Elimination Criteria:

Violation of the prescribed rule of medication that may influence the judgment of curative effect and safety.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Radiological progression free survival (rPFS)
大体时间:From date of randomisation to until radiographic progression (up to 1 year)
Radiological progression free survival (rPFS) - defined as the time from randomisation to radiological progression, assessed by investigator per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 (soft tissue) and Prostate Cancer Working Group-3 (PCWG-3) criteria (bone), or death from any cause, or the last follow-up, whichever occurs first
From date of randomisation to until radiographic progression (up to 1 year)
Objective Response Rate (ORR)
大体时间:From randomisation until radiographic progression (up to 1 year)
ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)). Per RECIST v1.1, CR=Disappearance of all target lesions; PR = >=30% decrease in the sum of diameters of target lesions; For each treatment group, ORR is the number of patients with a CR and PR.
From randomisation until radiographic progression (up to 1 year)
PSA response rate
大体时间:From randomisation until radiographic progression (up to 1 year)
PSA response rate is defined as the proportion of patients with a PSA decline (defined as a ≥30%, ≥50% and other declines in PSA from baseline).
From randomisation until radiographic progression (up to 1 year)

次要结果测量

结果测量
措施说明
大体时间
Overall Survival (OS)
大体时间:2 years
OS is defined as time from treatment commencement to death of any cause
2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Yonghong Li, M.D.、Sun Yat-sen University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2021年10月31日

初级完成 (预期的)

2023年3月31日

研究完成 (预期的)

2023年8月31日

研究注册日期

首次提交

2021年11月1日

首先提交符合 QC 标准的

2021年11月1日

首次发布 (实际的)

2021年11月11日

研究记录更新

最后更新发布 (实际的)

2021年11月11日

上次提交的符合 QC 标准的更新

2021年11月1日

最后验证

2021年11月1日

更多信息

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在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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