Trial Title:
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
NCT ID:
NCT05691608
Condition:
Solid Tumor
Leukemia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Solid tumor and CT DNA
Description:
Biopsy and blood sample
Arm group label:
Patient with solid tumor or leukemia (no treatment)
Summary:
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.
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
6 Years
Maximum age:
25 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Gustave Roussy
Address:
City:
Paris
Zip:
94800
Country:
France
Status:
Recruiting
Contact:
Last name:
Birgit GEOERGER, MD
Email:
birgit.geoerger@gustaveroussy.fr
Contact backup:
Last name:
Jean-Luc JOANNIC, PhD
Phone:
+33 (0)142114794
Email:
jeanluc.joannic@gustaveroussy.fr
Facility:
Name:
CHU Angers
Address:
City:
Angers
Zip:
49933 Cedex 9
Country:
France
Status:
Recruiting
Contact:
Last name:
Emilie DE CARLI, Dr
Phone:
+33 (0)2 41 35 36 37
Email:
emdecarli@chu-angers.fr
Facility:
Name:
CHU Besançon
Address:
City:
Besançon
Zip:
25030
Country:
France
Status:
Recruiting
Contact:
Last name:
Sébastien KLEIN, Dr
Phone:
+33 (0)3 81 66 81 66
Email:
s1klein@chu-besancon.fr
Facility:
Name:
CHU Pellegrin
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Contact:
Last name:
Stéphane DUCASSOU, Dr
Phone:
+33 (0)5 56 79 56 79
Email:
stephane.ducassou@chu-bordeaux.fr
Facility:
Name:
CHRU Morvan
Address:
City:
Brest
Zip:
29200
Country:
France
Status:
Recruiting
Contact:
Last name:
Liana CARAUSU, Dr
Phone:
+33 (0)2 98 22 33 33
Email:
liana.carausu@chu-brest.fr
Facility:
Name:
CHU de Caen
Address:
City:
Caen
Zip:
14000
Country:
France
Status:
Recruiting
Contact:
Last name:
Damien BODET, Dr
Phone:
+33 (0)2 31 06 31 06
Email:
bodet-d@chu-caen.fr
Facility:
Name:
CHU Estaing
Address:
City:
Clermont-Ferrand
Zip:
63000
Country:
France
Status:
Recruiting
Contact:
Last name:
Justyna KANOLD, Dr
Phone:
+33 (0)4 73 75 07 50
Email:
jkanold@chu-clermontferrand.fr
Facility:
Name:
CHU Dijon François Mitterand
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Recruiting
Contact:
Last name:
Florent NEUMANN, Dr
Phone:
+33 (0)3 80 29 30 31
Email:
florent.neumann@chu-dijon.fr
Facility:
Name:
CHU Grenoble Alpes
Address:
City:
Grenoble
Zip:
38043
Country:
France
Status:
Recruiting
Contact:
Last name:
Anne PAGNIER, Dr
Phone:
+33 (0)4 76 76 75 75
Email:
apagnier@chu-grenoble.fr
Facility:
Name:
Centre Oscar Lambret
Address:
City:
Lille
Zip:
59020
Country:
France
Status:
Recruiting
Contact:
Last name:
Sandra RAIMBAULT, Dr
Phone:
+33 (0)3 20 29 59 59
Email:
s-raimbault@o-lambret.fr
Facility:
Name:
Chu Limoges
Address:
City:
Limoges
Zip:
87000
Country:
France
Status:
Recruiting
Contact:
Last name:
Thomas LAUVRAY, MD
Phone:
+33 (0)5 55 05 55 55
Email:
Thomas.LAUVRAY@chu-limoges.fr
Facility:
Name:
IHOP
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Recruiting
Contact:
Last name:
Nadège Corradini, MD,PHD
Phone:
+33 (0)4 69 16 65 95
Email:
nadege.corradini@ihope.fr
Facility:
Name:
CHU La Timone
Address:
City:
Marseille
Zip:
13005
Country:
France
Status:
Recruiting
Contact:
Last name:
Nicolas ANDRE, Pr
Phone:
+33 (0)4 91 38 00 00
Email:
Nicolas.ANDRE@ap-hm.fr
Facility:
Name:
CHU Arnaud de Villeneuve
Address:
City:
Montpellier
Zip:
34295
Country:
France
Status:
Recruiting
Contact:
Last name:
Stéphanie HAOUY, Dr
Phone:
+33 (0)4 67 33 67 33
Email:
s-haouy@chu-montpellier.fr
Facility:
Name:
CHU Nantes
Address:
City:
Nantes
Zip:
44093
Country:
France
Status:
Recruiting
Contact:
Last name:
Morgane Clairec, Dr
Phone:
+33 (0)2 40 08 33 33
Email:
morgane.clairec@chu-nantes.fr
Facility:
Name:
CHU de Nice
Address:
City:
Nice
Zip:
06202
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre ROHRLICH, Dr
Phone:
+33 (0)4 92 03 77 77
Email:
rohrlich.ps@chu-nice.fr
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Recruiting
Contact:
Last name:
Gudrun Schleiermacher, MD,PHD
Phone:
+33 (0)1 56 24 55 00
Email:
gudrun.schleiermacher@curie.fr
Facility:
Name:
CHU Poitiers
Address:
City:
Poitiers
Zip:
86022 Cedex
Country:
France
Status:
Recruiting
Contact:
Last name:
Frédéric MILLOT, Pr
Phone:
+33 (0)5 49 44 44 44
Email:
Frederic.millot@chu-poitiers.fr
Facility:
Name:
CHU Reims- Hôpital Américain
Address:
City:
Reims
Zip:
51100
Country:
France
Status:
Recruiting
Contact:
Last name:
Claire PLUCHART, Dr
Phone:
+33 (0)3 26 78 78 78
Email:
cpluchart@chu-reims.fr
Facility:
Name:
CHU Rennes Hôpital Sud
Address:
City:
Rennes
Zip:
35203
Country:
France
Status:
Recruiting
Contact:
Last name:
Chloé PUISEUX, Dr
Phone:
+33 (0)2 99 28 43 21
Email:
Chloe.PUISEUX@chu-rennes.fr
Facility:
Name:
CHU de Rouen
Address:
City:
Rouen
Zip:
76000
Country:
France
Status:
Recruiting
Contact:
Last name:
Aude MARIE-CARDINE, Dr
Phone:
+33 2 32 88 89 90
Email:
aude.marie-cardine@chu-rouen.fr
Facility:
Name:
CHU de La Réunion site nord
Address:
City:
Saint-Denis
Zip:
97400
Country:
France
Status:
Recruiting
Contact:
Last name:
Yves REGUERRE, Dr
Phone:
+33 (0)2 62 90 50 50
Email:
yves.reguerre@chu-reunion.fr
Facility:
Name:
Hôpital de Hautepierre
Address:
City:
Strasbourg
Zip:
67200
Country:
France
Status:
Recruiting
Contact:
Last name:
Natacha ENTZ-WERLE, Dr
Phone:
+33 (0)3 88 11 67 68
Email:
Natacha.Entz-Werle@chru-strasbourg.fr
Facility:
Name:
Hôpital des Enfants - CHU de Toulouse
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Last name:
Marion GAMBART, Dr
Phone:
+33 (0)5 61 77 22 33
Email:
gambart.m@chu-toulouse.fr
Facility:
Name:
Hôpital Clocheville
Address:
City:
Tours
Zip:
37000
Country:
France
Status:
Recruiting
Contact:
Last name:
Julien LEJEUNE, Dr
Phone:
+33 (0)2 47 47 47 47
Email:
j.lejeune@chu-tours.fr
Facility:
Name:
CHRU Nancy Hôpital Enfants
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54500
Country:
France
Status:
Recruiting
Contact:
Last name:
Ludovic MANSUY, Dr
Phone:
+33 (0)3 83 85 85 85
Email:
lu.mansuy@chru-nancy.fr
Start date:
September 9, 2022
Completion date:
September 9, 2030
Lead sponsor:
Agency:
Gustave Roussy, Cancer Campus, Grand Paris
Agency class:
Other
Source:
Gustave Roussy, Cancer Campus, Grand Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05691608
