Informations générales (source: ClinicalTrials.gov)
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2 (MAPPYACTS2)
Interventional
N/A
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
septembre 2022
septembre 2030
19 octobre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:39 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Samuel ABBOU | 23/05/2024 13:27:47 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Oscar Lambret - 59020 - Lille - France | Sandra RAIMBAULT, Dr | Contact (sur clinicalTrials) | |||
| CHRU Morvan - 29200 - Brest - France | Liana CARAUSU, Dr | Contact (sur clinicalTrials) | |||
| CHRU Nancy Hôpital Enfants - 54500 - Vandœuvre-lès-Nancy - France | Ludovic MANSUY, Dr | Contact (sur clinicalTrials) | |||
| CHU Angers - 49933 Cedex 9 - Angers - France | Emilie DE CARLI, Dr | Contact (sur clinicalTrials) | |||
| CHU Arnaud de Villeneuve - 34295 - Montpellier - France | Stéphanie HAOUY, Dr | Contact (sur clinicalTrials) | |||
| CHU Besançon - 25030 - Besançon - France | Sébastien KLEIN, Dr | Contact (sur clinicalTrials) | |||
| CHU de Caen - 14000 - Caen - France | Damien BODET, Dr | Contact (sur clinicalTrials) | |||
| CHU de La Réunion site nord - 97400 - Saint-Denis - France | Yves REGUERRE, Dr | Contact (sur clinicalTrials) | |||
| CHU de Nice - 06202 - Nice - France | Pierre ROHRLICH, Dr | Contact (sur clinicalTrials) | |||
| CHU de Rouen - 76000 - Rouen - France | Aude MARIE-CARDINE, Dr | Contact (sur clinicalTrials) | |||
| CHU Dijon François Mitterand - 21079 - Dijon - France | Florent NEUMANN, Dr | Contact (sur clinicalTrials) | |||
| CHU Estaing - 63000 - Clermont-Ferrand - France | Justyna KANOLD, Dr | Contact (sur clinicalTrials) | |||
| CHU Grenoble Alpes - 38043 - Grenoble - France | Anne PAGNIER, Dr | Contact (sur clinicalTrials) | |||
| CHU La Timone - 13005 - Marseille - France | Nicolas ANDRE, Pr | Contact (sur clinicalTrials) | |||
| Chu Limoges - 87000 - Limoges - France | Thomas LAUVRAY, MD | Contact (sur clinicalTrials) | |||
| CHU Nantes - 44093 - Nantes - France | Morgane Clairec, Dr | Contact (sur clinicalTrials) | |||
| CHU Pellegrin - 33076 - Bordeaux - France | Stéphane DUCASSOU, Dr | Contact (sur clinicalTrials) | |||
| CHU Poitiers - 86022 Cedex - Poitiers - France | Frédéric MILLOT, Pr | Contact (sur clinicalTrials) | |||
| CHU Reims- Hôpital Américain - 51100 - Reims - France | Claire PLUCHART, Dr | Contact (sur clinicalTrials) | |||
| CHU Rennes Hôpital Sud - 35203 - Rennes - France | Chloé PUISEUX, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Clocheville - 37000 - Tours - France | Julien LEJEUNE, Dr | Contact (sur clinicalTrials) | |||
| Hôpital de Hautepierre - 67200 - Strasbourg - France | Natacha ENTZ-WERLE, Dr | Contact (sur clinicalTrials) | |||
| Hôpital des Enfants - CHU de Toulouse - 31059 - Toulouse - France | Marion GAMBART, Dr | Contact (sur clinicalTrials) | |||
| IHOP - 69373 - Lyon - France | Nadège Corradini, MD,PHD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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