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Prognostic and Predictive Factors in Childhood Soft Tissue Sarcomas (MAKI-France)

2026年11月2日 更新者:Institut Curie

The goal of this study is to better understand biological characteristics of non-rhabdomyosarcoma soft tissue sarcomas (NRSTS), a rare group of cancers that affect children, adolescents, and young adults. Researchers also aim to identify factors that could help predict how the disease will behave and respond to treatment.

The main questions it aims to answer are:

  • Can advanced molecular analyses improve the classification and diagnosis of NRSTS?
  • Can blood- and tumor-based biomarkers help predict outcomes and detect relapse earlier?
  • Can researchers identify biological features that may guide future personalized treatments?

Participants aged 0 to 25 years with a recent diagnosis of NRSTS will take part in the prospective study. Researchers will collect archived tumor samples and blood samples during routine follow-up (approximately every 3 to 4 months) and will analyze these samples using advanced laboratory techniques. Clinical information will also be collected over a follow-up period of up to 4 years.

150 participants will be enrolled in the prospective part from 28 investigating centers across France.

Tumor samples already collected as part of your care, together with blood samples taken during follow-up visits, will be stored for future researches.

研究概览

详细说明

MAKI-France is an ambispective study. In addition to the 150 participants to include in the prospective part, 300 tumors collected as part of routine care will be analyzed.

研究类型

观察性的

注册 (估计的)

150

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

      • Amiens、法国、80054
        • Chu Amiens
        • 首席研究员:
          • Antoine GOURMEL, MD
      • Angers、法国、49033
        • Chu Angers
        • 首席研究员:
          • Stéphanie PROUST, MD
      • Besançon、法国、25030
        • Chu Besancon
        • 首席研究员:
          • Victor PEREIRA, MD
      • Bordeaux、法国、33000
        • Chu Pellegrin
        • 首席研究员:
          • Jordane CHAIX, MD
      • Brest、法国、29609
        • Chru Brest
        • 首席研究员:
          • Liana CARAUSU, MD
      • Caen、法国、14033
        • CHU CAEN
        • 首席研究员:
          • Marianna DEPARIS, MD
      • Clermont-Ferrand、法国、63000
        • Chu Clermont Ferrand
        • 首席研究员:
          • Pauline GIRARD-MONIN, MD
      • Dijon、法国、21000
        • Chu Dijon
        • 首席研究员:
          • Florent NEUMANN, MD
      • Grenoble、法国、38043
        • Chu Grenoble
        • 首席研究员:
          • Séverine BOBILLIER-CHAUMONT, MD
      • Lille、法国、59020
        • Centre Oscar Lambret
        • 首席研究员:
          • Anne-Sophie DEFACHELLES-THOMASSIN, MD
      • Limoges、法国、87042
        • Chu Limoges
        • 首席研究员:
          • Thomas LAUVRAY, MD
      • Lyon、法国、69008
        • IHOPe - CENTRE LEON BERARD
        • 首席研究员:
          • Nadège CORRADINI, MD
      • Marseille、法国、13005
        • Chu La Timone - Hopital Enfants
        • 接触:
          • MD
        • 首席研究员:
          • Angélique ROME, MD
      • Montpellier、法国、34090
      • Nantes、法国、44093
      • Nice、法国、06200
        • CHU NICE
        • 首席研究员:
          • Morgane PODROM, MD
      • Paris、法国、75005
        • Institut Curie
        • 首席研究员:
          • Daniel ORBACH, MD
      • Paris、法国、75012
        • Ap-Hp - Hopital Trousseau
        • 首席研究员:
          • Hélène BOUTROUX, MD
      • Poitiers、法国、86021
        • CHU Poitiers
        • 首席研究员:
          • Chrystelle DUPRAZ, MD
      • Rennes、法国、35203
        • Chu de Rennes - Hôpital Sud
        • 首席研究员:
          • Jamie PROBERT, MD
      • Rouen、法国、76031
        • Chu Rouen
        • 首席研究员:
          • Aude MARIE-CARDINE, MD
      • Saint-Etienne、法国、42055
        • Chu Saint Etienne
        • 首席研究员:
          • Marina GOUTTENOIRE, MD
      • Strasbourg、法国、67000
        • Chu Strasbourg - Hôpital Hautepierre
        • 首席研究员:
          • Sarah JANNIER, MD
      • Toulouse、法国、31059
        • Chu Toulouse
        • 首席研究员:
          • Marie-Pierre CASTEX, MD
      • Tours、法国、37044
        • Chu Tours - Hôpital Clocheville
        • 首席研究员:
          • Jill SERRE, MD
      • Vandœuvre-lès-Nancy、法国、54500
        • CHU NANCY- Hôpital d'Enfants
        • 首席研究员:
          • Ludovic MANSUY, MD
      • Villejuif、法国、94800
        • Gustave Roussy
        • 接触:
          • 电话号码:+33 1 42 11 60 5
        • 首席研究员:
          • Lucy METAYER, MD
    • La Réunion
      • Saint-Denis、La Réunion、法国、97400
        • Chr Felix Guyon
        • 首席研究员:
          • Yves REGUERRE, MD

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

不超过 25年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Children and young adults (aged from 0 to 25 years) with a new diagnosis of NRSTS.

描述

Inclusion Criteria:

  1. Patients with local diagnosis of intermediate or malignant NRSTS, at the time of initial diagnosis only.
  2. Localized or metastatic disease.
  3. Age: 0-25 years.
  4. Whatever strategy is decided (observation, surgery, chemotherapy, radiotherapy, other systemic therapies).
  5. Within the 3 months after initial diagnosis.
  6. Written informed consent from adult patients, or the 2 parents/legal representatives. Assent from minor patients should be verified.
  7. Availability of archived tissue samples. Adult participants or parents must be willing to provide archival tissue. A minimum of 1 FFPE block / 1 HE slide with IHC slides available is required.
  8. Patient affiliated to a health insurance system.

Exclusion Criteria:

  1. NRSTS at relapse.
  2. Any significant medical, psychological, social or geographic conditions that, in the opinion of the Investigator, would impair study participation or cooperation.
  3. Patients deprived of their liberty or under guardianship.

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:CASE_ONLY
  • 时间观点:OTHER

队列和干预

团体/队列
干预/治疗
NRSTS group

Single arm for all patients. Tumor samples will be taken for histological and molecular profiling, at baseline (FFPE for routine care or tissue sample from surgery. Blood samples will be taken at baseline and every 3- months up to end of study post surgery.

Tumor samples will be taken for histological and molecular characterization at baseline (routine care biopsy) or surgery. Blood samples (liquid biopsies) will be taken at baseline and every 3-4 months up to end of study for early relapse detection

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
Histopathological profiling of NRSTS tumors
大体时间:Baseline

Histopathological description of NRSTS tumors based on analysis of tumor tissue in paraffin. Results will be reported as the number and percentage of tumors classified into each histological subtype.

Baseline
Molecular profiling of NRSTS tumors
大体时间:Baseline

Molecular profiling of NRSTS tumors combining DNA and RNA profiling, DNA methylation analysis, and clustering. Results will be reported as the number and percentage of tumors presenting identified molecular alterations.

Baseline

次要结果测量

结果测量
措施说明
大体时间
Percentage of patients with associated cfDNA and tumor tissue DNA methylation profiles in NRSTS
大体时间:Through study completion, an average of 4 years

Assessment of the association between DNA methylation profiles obtained from cell-free DNA (cfDNA) and matched tumor tissue DNA samples

Through study completion, an average of 4 years
Classification Accuracy of DNA Methylation-Based Classifiers for NRSTS Subtypes
大体时间:Baseline

Classification results for NRSTS subtypes obtained using the Institut Curie classifier based on DNA methylation and RNA profiling compared with those obtained using the Heidelberg classifier. Agreement in subtype classification and the distribution of classification results between the two classifiers will be reported.

Baseline
Percentage of patients with detectable cfDNA molecular changes associated with disease status or relapse.
大体时间:Through study completion, an average of 4 years

Detection and characterization of prognostic and epigenetic biomarkers using cell-free DNA (cfDNA) analysis at initial diagnosis and during follow-up assessments performed every 3-4 months. Changes in cfDNA methylation profiles over time and their association with disease status and relapse will be reported, including the detection of molecular changes potentially indicative of relapse.

Through study completion, an average of 4 years
Identification of prognostic and predictive biomarkers a in NRSTS
大体时间:Through study completion, an average of 4 years

Sensitivity and specificity of molecular biomarkers, including epigenetic alterations at diagnosis and relapse, such as fragmentomic profiles and nucleosome positioning, genomic index, CINCARC, and other prognostic molecular signatures, compared with conventional clinical assessment and imaging.

Through study completion, an average of 4 years
Percentage of synovial sarcoma organoids showing similar histological and molecular profiles to their parental tumors
大体时间:At the time of surgical resection, up to 4 years

Assessment of the similarity between synovial sarcoma organoids and their corresponding parental tumor tissues based on histological and molecular characterization.

At the time of surgical resection, up to 4 years
Impact of systematic national review on tumor diagnosis
大体时间:Baseline

Number and proportion of tumors with concordant diagnoses or diagnostic modifications following systematic pathological and molecular review at the National Reference Center in Lyon. Diagnostic modifications will be classified as minor, without significant clinical impact, or major, with clinical impact.

Baseline

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

  • 学习椅:Daniel ORBACH, MD、Institut Curie

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 (估计的)

2026年12月1日

初级完成 (估计的)

2034年12月1日

研究完成 (估计的)

2034年12月1日

研究注册日期

首次提交

2026年10月14日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月9日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • IC 2025-02
  • ID RCB : 2026-A00153-48 (其他标识符:ANSM)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

IPD 共享时间框架

Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.

IPD 共享访问标准

Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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