在社区医院实施精准医疗 (PRISM-POrTAL)
This is a prospective biomarker study that aims at demonstrating the impact of liquid biopsy to deliver better treatment for cancer patients with metastatic disease managed in the community setting
研究概览
详细说明
Patients will be selected to present a metastatic cancer (de novo or relapse after primary tumor treatment) eligible for a first line treatment (chemotherapy, immunotherapy, endocrine therapy or targeted therapy).
All tumor subtype could be enrolled in the study; metastatic prostate cancer must be resistant to castration. Triple negative breast cancer and Hormone receptor positive, Her2-negative metastatic breast cancer resistant to endocrine therapy are eligible to the study.
A plasma sample will be collected at baseline and will be tested for a large panel of gene and MSI status using Next Generation Sequencing (NGS) (cf table). Results will be discussed within a Molecular Tumor Board (MTB) with all declared centers.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Antoine Italiano, MD
- 电话号码：+33 (0)1 42 11 42 11
- 邮箱：antoine.italiano@gustaveroussy.fr
研究联系人备份
- 姓名：Benjamin Verret, MD
- 电话号码：+33 (0)1 42 11 42 11
- 邮箱：Benjamin.verret@gustaveroussy.fr
学习地点
-
-
-
Noumea、新喀里多尼亚、98800
- 主动，不招人
- Clinique Kuindo Magnin
-
-
-
-
-
Bayonne、法国、64100
- 招聘中
- CH de la Côte Basque
-
接触：
- Thomas Grellety, MD
- 邮箱：tgrellety@ch-cotebasque.fr
-
Bligny、法国
- 招聘中
- CH de Bligny
-
接触：
- Ingrid Alexande, MD
- 邮箱：I.ALEXANDRE@chbligny.fr
-
Bordeaux、法国、33300
- 主动，不招人
- Polyclinique Bordeaux Nord Aquitaine
-
Corbeil-Essonnes、法国、91106
- 招聘中
- CH Sud Francilien
-
接触：
- Joel Ezenfis, MD
- 邮箱：joel.ezenfis@chsf.fr
-
Grenoble、法国、38028
- 主动，不招人
- GHM de Grenoble
-
La Réunion、法国、97448
- 招聘中
- CHU de La Réunion
-
接触：
- Mohamed KHETTAB, MD
- 邮箱：mohamed.khettab@chu-reunion.fr
-
Melun、法国、77000
- 主动，不招人
- Clinique Saint-Jean l'ermitage
-
Neuilly-sur-Seine、法国、92200
- 招聘中
- Hôpital Américain
-
接触：
- Mahasti SAGHATCHIAN, Md
- 邮箱：mahasti.saghatchian@ahparis.org
-
Orléans、法国、45100
- 招聘中
- Hôpital de la source - CHR d'Orléans
-
接触：
- Heba DAWOOD, MD, PhD
- 电话号码：+33 (2) 38 51 40 87
- 邮箱：heba.dawood@chr-orleans.fr
-
Paris、法国、75014
- 招聘中
- Institut Mutualiste Montsouris
-
接触：
- David MALKA, MD, PhD
- 电话号码：+33 (1) 56 61 62 63
- 邮箱：david.malka@imm.fr
-
Paris、法国、75014
- 招聘中
- Hôpital Saint-Joseph
-
接触：
- Charles Naltet, MD
- 邮箱：cnaltet@ghpsj.fr
-
Paris、法国、75020
- 招聘中
- Groupement Hospitalier Diaconesses-Croix
-
接触：
- Antoine ANGELERGUES, MD
- 邮箱：aangelergues@hopital-dcss.org
-
Pau、法国、64046
- 招聘中
- Centre Hospitalier
-
接触：
- Kevin Bourcier, MD
- 邮箱：kevin.bourcier@ch-pau.fr
-
Rennes、法国、35042
- 招聘中
- Centre Eugène Marquis
-
接触：
- Christophe Massard, MD
- 邮箱：c.massard@rennes.unicancer.fr
-
Saint-Etienne、法国、42100
- 主动，不招人
- Hôpitaux Privés de la Loire
-
Saint-Mandé、法国、94160
- 招聘中
- HIA Bégin
-
接触：
- Carole Hélissey, MD
- 电话号码：+33 (0)1 43 98 51 66
- 邮箱：carole.helissey@gmail.com
-
Suresnes、法国、92150
- 尚未招聘
- Hôpital Foch
-
接触：
- Jaafar BENNOUNA, MD
- 电话号码：+33 (0)1 46 25 19 75
- 邮箱：j.bennouna@hopital-foch.com
-
Villefranche-sur-Saône、法国、69655
- 招聘中
- Hôpital Nord-Ouest Villefranche-sur-Saône
-
接触：
- Boris Morel, MD
- 邮箱：bomorel@lhopitalnordouest.fr
-
Épagny、法国、74370
- 主动，不招人
- CH Annecy Genevois
-
-
-
-
-
Pirae、法属波利尼西亚、98716
- 主动，不招人
- CHPF
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Participants are eligible to be included in the study only if they meet all of the following criteria:
- Age ≥ 18 years
- Histology: solid malignant tumor
- Locally advanced/unresectable and/or metastatic (for prostate cancer: castration resistant prostate cancer, for RH+/HER2- breast cancer: prior treatment with endocrine therapy plus anti-CDK4/6 inhibitor)
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Measurable disease as per RECIST criteria
- Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code)
- Voluntary signed and dated written informed consent prior to any study specific procedure.
Exclusion Criteria:
Participants will be excluded from the study if they meet any of the following criteria:
- Radiological evidence of symptomatic or progressive brain metastases
- Previous or current malignancies of others histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer
- Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
- Minors (Age < 18 years)
- Pregnant or breast-feeding women
- Previous enrollment in the present study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Biopsy liquid contributive
Patients presenting for whom ct DNA sequencing |
Patient performs a blood test at treatment baseline |
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 |
|---|---|---|
|
Proportion of patients for whom ctDNA sequencing
大体时间：72 months
|
The primary objective of the study will be to evaluate the impact of ctDNA sequencing on the treatment plan of cancer patients managed in satellite centers. This will be performed by estimating the proportion of patients for whom ctDNA sequencing has allowed to propose a systemic treatment that was not considered before the clinician. |
72 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
分子筛选失败率
大体时间：72个月
|
72个月
|
|
|
液体活检和匹配的治疗开始之间的复发时间
大体时间：72个月
|
72个月
|
|
|
客观响应率
大体时间：72个月
|
72个月
|
|
|
接受匹配的疗法治疗的患者的总生存率
大体时间：72个月
|
72个月
|
|
|
Utilization rates of molecular profiling information
大体时间：72 months
|
The utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies) |
72 months
|
|
Rate of patients presenting targetable alterations
大体时间：72 months
|
The rate of patients presenting targetable alterations according to alterations subtypes (copy number/mutation/oncogenic fusions) |
72 months
|
|
Utilization rate of tumor mutational burden
大体时间：72 months
|
The utilization rate of tumor mutational burden (TMB - based on new generation sequencing panels) |
72 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.