MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2 (MAPPYACTS2)

August 21, 2025 updated by: Gustave Roussy, Cancer Campus, Grand Paris

FMG2025 continues the previous efforts to propose treatment for patients based on the molecular characteristics of their tumor at treatment failure in cancer precision medicine trials within standard of care in France. However, whereas FMG2025 is a descriptive effort providing the basis for clinical decisions, MAPPYACTS 2 will translate these findings to clinical actions. The symbiosis is critical to advance patient care.

Since 2012, the molecular profiling trials "MOlecular Screening for CAncer Treatment Optimization" (MOSCATO-01) and "MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification" (MAPPYACTS) have included pediatric and adolescent patients with recurrent or refractory malignancy that underwent on-purpose biopsy or surgical intervention. Whole Exome Sequencing of tumor and normal tissue and RNA Sequencing of tumor tissue have been applied to detect genomic alterations that could lead to an adapted targeted treatment. Furthermore, ancillary studies were associated exploring circulating tumor DNA, the immune contexture of tumors and developing Patient-Derived Xenografts (PDX).

The FMG2025 project transfers the molecular profiling of advanced pediatric cancers into a global approach that is now considered standard of care in France. Subsequent clinical recommendations and decisions will be made based on discussions with biologists, scientist and physicians in the molecular and clinical molecular tumor boards. Associated ancillary research studies and links to clinical interventional studies remain essential elements of the program to provide clinical, translational and basic research in order to improve scientific knowledge.

The program is articulated in two main parts that are closely interacting:

FMG2025 - Cancers et leucémies pédiatriques en échec de traitement or equivalent international projects that cover the sequencing of tumor and blood samples and provide molecular reports.

The clinical study MAPPYACTS 2 that provides clinical and therapeutic discussions of the sequencing results and therapy recommendations via the clinical molecular tumor board reports. It collects molecular and comprehensive clinical data of the patients registered in FMG2025 or equivalent international projects and thereby constitutes the critical link to clinical interventional studies and its sponsors ensuring facilitated access to these trials. It also covers and coordinates ancillary research studies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

MAPPYACTS 2 is a prospective international multicentric clinical study to provide clinical therapeutic recommendations, to set up the molecular and comprehensive clinical database of patients with relapsed or refractory pediatric malignancies in FMG2025 - Cancers et leucémies pédiatriques en échec de traitement or equivalent international projects, to collect the follow-up data on treatment and patients' outcome, in order to determine the outcome of the program in regard to benefit to the patient, all the patients and to health care. It will also serve as a central link to interventional study platforms and international precision medicine programs, and to cover and coordinate ancillary research studies that lead to improved treatment and outcome for children with advanced malignancies.

Subsequent clinical recommendations and decisions will be made based on discussions with biologists, scientists and physicians in the molecular and clinical molecular tumor boards run by the MAPPYACTS 2 study teams.

Associated ancillary research studies and links to clinical interventional studies are essential components of the program to perform clinical, translational and basic research in order to generate scientific knowledge and develop new treatment strategies that improve outcome of these patients. Research projects will be discussed and agreed on in the MAPPYACTS 2 study committee.

Study Type

Interventional

Enrollment (Estimated)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80054
        • Recruiting
        • CHU Amiens-Picardie
        • Contact:
        • Principal Investigator:
          • Antoine GOURMEL, Dr
      • Angers, France, 49933 Cedex 9
        • Recruiting
        • CHU Angers
        • Contact:
      • Besançon, France, 25030
        • Recruiting
        • CHU Besançon
        • Contact:
      • Bordeaux, France, 33076
      • Brest, France, 29200
      • Caen, France, 14000
        • Recruiting
        • CHU de Caen
        • Contact:
      • Clermont-Ferrand, France, 63000
      • Dijon, France, 21079
        • Recruiting
        • CHU Dijon François Mitterand
        • Contact:
      • Grenoble, France, 38043
        • Recruiting
        • Chu Grenoble Alpes
        • Contact:
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
      • Limoges, France, 87000
      • Lyon, France, 69373
      • Marseille, France, 13005
        • Recruiting
        • CHU La Timone
        • Contact:
      • Montpellier, France, 34295
        • Recruiting
        • CHU Arnaud de Villeneuve
        • Contact:
      • Nantes, France, 44093
      • Nice, France, 06202
        • Recruiting
        • CHU de Nice
        • Contact:
      • Paris, France, 75005
      • Paris, France, 75012
        • Recruiting
        • Hôpital Armand Trousseau
        • Contact:
      • Poitiers, France, 86022 Cedex
      • Reims, France, 51100
        • Recruiting
        • CHU Reims- Hôpital Américain
        • Contact:
      • Rennes, France, 35203
      • Rouen, France, 76000
      • Saint Etienne, France, 42270
      • Saint-Denis, France, 97400
      • Strasbourg, France, 67200
      • Toulouse, France, 31059
        • Recruiting
        • Hôpital des Enfants - CHU de Toulouse
        • Contact:
      • Tours, France, 37000
        • Recruiting
        • Hôpital Clocheville
        • Contact:
      • Vandœuvre-lès-Nancy, France, 54500
        • Recruiting
        • CHRU Nancy Hôpital Enfants
        • Contact:
    • Villejuif

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patient referred for sequencing of the tumor within the FMG2025 or equivalent program and written informed consent for FMG2025 "Cancers et leucémies pédiatriques en échec de traitement" or equivalent, according to local regulations
  • Written informed consent of MAPPYACTS 2 to collect molecular and comprehensive clinical data on cancer diagnosis, therapies, therapy outcomes, to provide clinical therapeutic recommendations, to collect follow-up data on treatment and patients' outcome; optional written consents to perform to ancillary research studies, according to local regulations. The written consent will include access to reimbursement data from the French national health insurance through linkage with the Système National des Données de Santé (SNDS) or equivalent.
  • Patient with histologically/cytologically confirmed solid tumor or leukemia which is relapsed or refractory to standard treatment and who is potentially eligible for an experimental treatment or an early phase clinical trial
  • Planned tumor biopsy, surgical resection, bone marrow or blood sample or recently (preferably within the last 3 months) archived frozen tumor material available of the current recurrent or refractory disease
  • Patients aged ≤ 25 years at the time of initial diagnosis
  • Performance status and life expectancy > 3 months expected to allow enrolment into an clinical trial
  • Patients affiliated with a Social Security Regimen or beneficiary of the same, as per local regulatory requirements

Exclusion Criteria:

  • Any concurrent illness or laboratory abnormality that, in the opinion of the investigator, is likely to interfere with the interpretation of study results
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with solid tumor or leukemia (no treatment)
Biological: Solid tumor and CT DNA
Biopsy and blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 3 years
Defined as the time from study entry to death whatever the cause of death, after 3 years, for the whole cohort and according to cancer type.
3 years
The number of additional technologies and new treatment strategies that are introduced in the care for advanced pediatric cancers through this research program.
Time Frame: 3 years
The number of patients receiving matched targeted treatments The number of new treatment strategies that are introduced in the care for advanced pediatric cancers through this research program The number of additional technologies that are introduced in the care for advanced pediatric cancers through this research program
3 years
The types of additional technologies and new treatment strategies that are introduced in the care for advanced pediatric cancers through this research program.
Time Frame: 3 years
The type of patients receiving matched targeted treatments The type of new treatment strategies that are introduced in the care for advanced pediatric cancers through this research program The type of additional technologies that are introduced in the care for advanced pediatric cancers through this research program
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate on treatment attributed by the molecular tumor board in the clinical trial, overall and according to the treatment decision
Time Frame: 3 years

Objective tumor response measured according to the standard for each tumor entity (i.e. RECIST 1.1, INRC, RANO, etc.).

Assessed for the whole cohort, for each disease entity as well as for each suggested treatment and until last follow-up.

The number and proportion of patients that are suggested to receive a matched targeted agent Direct medical costs including the planned or recently performed intervention
3 years
Progression-free survival (PFS)
Time Frame: 3 years

Defined as the time interval from start of attributed treatment (targeted or not) to progression or death.

They will be assessed for the whole cohort, for each disease entity as well as for each suggested treatment and until last follow-up.
3 years
5-year overall survival
Time Frame: 5 years

Defined as the time from study entry to death whatever the cause of death, after 5 years.

They will be assessed for the whole cohort, for each disease entity as well as for each suggested treatment and until last follow-up.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Principal Investigator: Birgit GEOERGER, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2022

Primary Completion (Estimated)

September 9, 2030

Study Completion (Estimated)

September 9, 2030

Study Registration Dates

First Submitted

December 12, 2022

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-A02990-41
  • 2021-3321 (Other Identifier: CSET NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol Informed Consent Form

IPD Sharing Time Frame

Data will become available in January 2023 The duration of the availability is up to 2030.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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