Molecular profiling for treating pediatric and young adult cancers
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
This study is testing if using genetic information from tumors can help doctors find better treatments for kids and young adults with hard-to-treat cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 6 Years to 25 Years |
| Sex | All |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris Academic / other |
| Locations | 29 sites (Paris, Villejuif and 28 other locations) |
| Trial ID | NCT05691608 on ClinicalTrials.gov |
What this trial studies
MAPPYACTS 2 is an international multicentric clinical initiative aimed at providing tailored therapeutic recommendations based on the molecular characteristics of tumors in pediatric and young adult patients with relapsed or refractory malignancies. The study utilizes advanced genomic techniques, including Whole Exome Sequencing and RNA Sequencing, to identify genomic alterations that may inform targeted treatment options. It also aims to create a comprehensive clinical database to track treatment outcomes and enhance patient care through collaboration among biologists, scientists, and physicians. The program will link to interventional studies and ancillary research to foster the development of new treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include pediatric and young adult patients with relapsed or refractory solid tumors or leukemia who are eligible for molecular profiling and potential experimental treatments.
Not a fit: Patients with tumors that are not relapsed or refractory to standard treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for children and young adults with difficult-to-treat cancers.
How similar studies have performed: Previous studies utilizing molecular profiling for cancer treatment have shown promise, indicating that this approach is building on established methodologies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris, Villejuif and 28 other locations
- Gustave Roussy — Paris, Villejuif, France (Recruiting)
- CHU Amiens-Picardie — Amiens, France (Recruiting)
- CHU Angers — Angers, France (Recruiting)
- CHU Besançon — Besançon, France (Recruiting)
- CHU Pellegrin — Bordeaux, France (Recruiting)
- CHRU Morvan — Brest, France (Recruiting)
- CHU de Caen — Caen, France (Recruiting)
- CHU Estaing — Clermont-Ferrand, France (Recruiting)
- CHU Dijon François Mitterand — Dijon, France (Recruiting)
- CHU Grenoble Alpes — Grenoble, France (Recruiting)
- Centre Oscar Lambret — Lille, France (Recruiting)
- Chu Limoges — Limoges, France (Recruiting)
- Ihop — Lyon, France (Recruiting)
- CHU La Timone — Marseille, France (Recruiting)
- CHU Arnaud de Villeneuve — Montpellier, France (Recruiting)
- CHU Nantes — Nantes, France (Recruiting)
- CHU de Nice — Nice, France (Recruiting)
- Institut Curie — Paris, France (Recruiting)
- Hopital Armand Trousseau — Paris, France (Recruiting)
- CHU Poitiers — Poitiers, France (Recruiting)
- CHU Reims- Hôpital Américain — Reims, France (Recruiting)
- CHU Rennes Hôpital Sud — Rennes, France (Recruiting)
- CHU de Rouen — Rouen, France (Recruiting)
- CHU de La Réunion site nord — Saint-Denis, France (Recruiting)
- CHU Saint Etienne — Saint-Etienne, France (Recruiting)
- Hôpital de Hautepierre — Strasbourg, France (Recruiting)
- Hôpital des Enfants - CHU de Toulouse — Toulouse, France (Recruiting)
- Hôpital Clocheville — Tours, France (Recruiting)
- CHRU Nancy Hôpital Enfants — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Principal investigator: Birgit GEOERGER, MD — Gustave Roussy, Cancer Campus, Grand Paris
- Study coordinator: Birgit GEOERGER, MD
- Email: Birgit.GEOERGER@gustaveroussy.fr
- Phone: +33 (0)1 42 11 46 61
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.