Clinico-biological Study/Characterization of Rhabdomyosarcoma in Adolescents and Young Adults, 15-25-year-old Patients

NCT03462888 | Active Not Recruiting

• 1 other identifier: RMS-AJA-1701
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 20

Brief Summary

Rhabdomyosarcoma (RMS) stands for the most frequent soft tissue sarcoma in children and, adolescents and young adults (AYA, 15-25-year-old population), accounting for approximately half of the whole soft tissue sarcomas in these populations.. Conversely, RMS represents a very small proportion of the soft tissue sarcomas in adults (3%), that is less than 1% of all solid cancers of adults. To date, previous studies undertaken among the paediatric population have pointed out several prognostic factors such as tumor localisation, tumor invasiveness at diagnosis, tumor size, histological subset, and treatment plans. Age at diagnosis remains an independent prognostic factor. RMS management is consensual in Europe for paediatric population, essentially based on the protocol RMS 2005 within the framework of the European Paediatric Soft tissue sarcoma Study Group (EpSSG). Care in AYAs remain heterogeneous and are either achieved in paediatric department, according to EpSSG guidelines, or in oncology department, known as "adult unit", depending on ESMO (European Society for Medical Oncology), which are non-specific recommendations for the management of rhabdomyosarcoma. No consensus has been published yet for RMS in AYA despite the growing interest in cancers in AYA population - topic.supported by the French National Cancer Institute (INCa) - and the increasing network between paediatricians and adult-oncologists. Thus management of RMS in AYA remains patchy/unequal depending on the type of care unit. Herein, with the support of the Oscar Lambret Center, we aim at assessing and identifying clinico-biological prognostic factors of rhabdomyosarcoma in AYA. Eventually, we hope to offer a standardized treatment to this population. Data collected from medical file will be anonymised in a confidential database of which the recipient is the sponsor of the study. The ancillary study will aim at characterizing the molecular profile of the difficult-to-classify RMS subtypes (fusiform or pleomorphic subsets) in molecular biology for ambiguous cases. From a scientific point of view, this study aims at understanding the parameters that may influence the prognosis of RMS in AYAs by evaluating various clinical and biological factors. Biologically, molecular profiling of RMS in AYA may improve the characterization of this tumour in this age group. At the clinical level, the completeness of the data collected will lead to a better description of RMS in AYAs. We hope to harmonize their therapeutic management by providing therapeutic adjustments according to population subsets. Finally, these results could also help to adapt the therapeutic management of AYAs within the framework of the European protocol that is currently under construction, and will involve both children and adults.

Conditions

Rhabdomyosarcoma

Keywords

Rhabdomyosarcoma; Adolescents and young adults; prognostic factors; molecular profiling

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  To estimate progression-free survival in AYA patients with RMS, according to clinical factors known as prognostic in children, and of biological factors (MYOD1 mutation in non-alveolar tumor; FOXO1).

  3 years after diagnosis

Secondary Outcomes (4)

• Clinical parameters of RMS in AYA

  9 months

• Biological parameters of RMS in AYA

  9 months

• therapeutic strategy

  9 months

• Overall survival (OS)

  3 years after diagnosis

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* Patients aged from 15 to 25 years old at diagnosis * Patients registered in EpSSG RMS 2005 trial, or RRePS / NerSarc /

You may qualify if:

• Patients aged from 15 to 25 years old at diagnosis
• Patients registered in EpSSG RMS 2005 trial, or RRePS / NerSarc / Conticabase databases
• Over the period from 2006 to 2014
• Rhabdomyosarcoma histologically proven
• Localized or metastatic
• Histological review and molecular biology available
• No previous treatment except surgery
• No previous cancer
• Absence of known serious chronic illness
• Patient and/or parents information and non-opposition to data collection

You may not qualify if:

• Age over 25 years, or under 15 years
• Other histologies

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• Centre Leon Berard: collaborator
• Société Française de lutte contre les Cancers et les leucémies de l'Enfant et l'adolescent: collaborator
• French Sarcoma Group: collaborator
• Ligue contre le cancer, France: collaborator

Study Sites (20)

BORDEAUX Bergonié

Bordeaux, 33076, France

Location

Bordeaux Chu

Bordeaux, France

Location

Brest Chu

Brest, 29609, France

Location

LILLE Centre Oscar Lambret/ CHRU de Lille

Lille, 59020, France

Location

LYON- Bérard

Lyon, 69373, France

Location

MARSEILLE La Timone

Marseille, 13385, France

Location

Montpellier Chu

Montpellier, 34295, France

Location

MONTPELLIER ICM Val d'Aurelle

Montpellier, 34298, France

Location

CHU de Nancy

Nancy, 54035, France

Location

Nantes Chu

Nantes, 44093, France

Location

NANTES Institut de Cancérologie de l'Ouest

Nantes, France

Location

NICE CHU

Nice, 06003, France

Location

NICE Centre Antoine Lacassagne

Nice, 06189, France

Location

PARIS Curie

Paris, 75005, France

Location

Poitiers Chu

Poitiers, 86000, France

Location

Strasbourg Chru

Strasbourg, 67098, France

Location

TOULOUSE Institut Claudius Regaud

Toulouse, 31059, France

Location

TOURS CHU-Bretonneau/Hôp G de Clocheville

Tours, 37044, France

Location

NANCY Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Villejuif Igr

Villejuif, France

Location

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Tissue extracted at diagnosis from biopsy or from surgical resection of the primary tumor

MeSH Terms

Conditions

Rhabdomyosarcoma

Condition Hierarchy (Ancestors)

Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 13, 2018
• Study Start: February 2, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

FR (20)