Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05691608
Status:
RECRUITING
Last Update Posted:
2023-01-20
First Post:
2022-12-12
Brief Title:
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAPPYACTS2
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-3321 | OTHER | CSET NUMBER | None |