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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03496402
Other study ID # IC 2017-02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 20, 2018
Est. completion date August 19, 2027

Study information

Verified date May 2023
Source Institut Curie
Contact Gudrun SCHLEIERMACHER, MD
Phone +33(0)144324554
Email gudrun.schleiermacher@curie.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Methodology: Prospective, multicentric, open, non-randomised, non-therapeutic, interventional study


Description:

To identify and characterise: - meaningful molecular genetic alterations, - meaningful immunological features of high risk childhood, adolescents and young adult cancers, at diagnosis, during patient treatment and follow-up (time dimension).


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date August 19, 2027
Est. primary completion date April 19, 2027
Accepts healthy volunteers No
Gender All
Age group 1 Year to 25 Years
Eligibility Inclusion Criteria: 1. Inclusion within 3 months after diagnosis 2. Availability of a cryopreserved tumour sample (primary and/or metastatic and/or lymph nodes) or peripheral blood or bone marrow samples (if invasion more than 30% of lymphoblasts) for leukaemias, obtained at the time of diagnosis during a routine procedure 3. Availability of a formalin-fixed paraffin-embedded (FFPE) tumour sample (primary and/or metastasis and/or lymph nodes), obtained at the time of diagnosis during a routine procedure (except for leukaemia patients) 4. Age: = 25 years at diagnosis 5. Written patient informed consent, or parents or legal representative written informed consent and assent of the child and the adolescent 6. Compulsory affiliation to a social security scheme Additional inclusion criteria for the study: To avoid multiple sampling for children, adolescents and young adults with cancer, patients already included or to be included in a study with similar analyses and/or objectives might also be included in MICCHADO study and in this case, samples or data might be exchanged on a collaborative basis. Cohort 1: - High risk neuroblastoma: - Any type of neuroblastoma with MYCN amplification, except INSS stage 1 - Stage 4 neuroblastoma in children older than one year at diagnosis - High risk rhabdomyosarcoma: - Foxo1 rearrangement any stage; - and / or N1 ; - and / or metastatic rhabdomyosarcoma - High risk Ewing sarcoma: - Metastatic Ewing sarcoma family of tumours (ESFT) - Localised inoperable Ewing sarcoma with primary tumours = 200 ml - High risk osteosarcoma: - Metastatic osteosarcoma - Localised inoperable osteosarcoma - High risk leukaemia: - Secondary acute myeloid leukaemia - Biphenotypic acute leukaemia Cohort 2: • Extra cerebral or cerebral high risk tumours including: - other metastatic sarcomas, - other rare high risk cancers, - high risk renal tumours with surgery after an initial chemotherapy - rhabdoid brain tumours (AT/RT) and extra cerebral rhabdoid tumours - high risk or metastatic cancers of unclear histological diagnosis • Lymphoblastic leukaemia with high MRD at Day 78 (time point 2) • Very high risk T-cells acute lymphoblastic leukaemia: - MRD = 10-2 at the end of the induction ; - or MRD = 10-3 at Day 78 Cohort 3: Children, adolescents and young adults, with low/intermediate risk cancers belonging to the following types: • Neuroblastoma: - Localised, without MYCN amplification - Localised, INSS stage 1, with MYCN amplification - Stage 4s, in infants (younger than one year at diagnosis), without MYCN amplification • Rhabdomyosarcoma: - Localised, without Foxo1 rearrangement • ESFT: - All non-high risk localised ESFT • Osteosarcoma: - All non-high risk localised osteosarcoma Exclusion Criteria: Main non-inclusion Criteria common to all study cohorts: 1) Age: patients > 25 years old at diagnosis 2) Absence of patient or parents or legal representative written informed consent 3) Patient for whom follow-up by the investigating centre does not appear feasible

Study Design


Intervention

Other:
Sampling on blood, bone marrow and cerebrospinal fluid
biological sampling during treatment and follow-up

Locations

Country Name City State
France Chu D'Amiens Picardie Amiens
France CHU Angers Angers
France CHRU de Besançon - Hôpital Jean-Minjoz Besançon
France CHU de Bordeaux - Hôpital des enfants - Groupe Hospitalier Pellegrin Bordeaux
France CHRU de Brest Brest
France CHU CAEN Caen
France Centre Régional de Cancérologie et Thrapie Cellulaire Pdiatrique (CRCTCP) Clermont-Ferrand
France CHU Hôpital d'Enfants Dijon
France CHU GRENOBLE Alpes - Hôpital Couple-Enfant Grenoble
France Centre Oscar Lambret Lille
France CHU de Limoges - Hôpital Mère-Enfant Limoges
France Centre Léon Bérard Lyon
France Hospices Civils de Lyon Lyon
France Hôpital d'Enfants de la Timone (AP-HM) Marseille
France CHU Arnaud de Villeneuve Montpellier
France CHU Nantes - Hôpital Mère Enfant Nantes
France Hôpital l'Archet 2 Nice
France Hôpital d'Enfants Armand-Trousseau Paris
France Hôpital universitaire Robert-Debré (AP-HP) Paris
France Institut Curie Paris
France CHU de Poitiers Poitiers
France CHU de Reims - Hôpital Américain Reims
France Chu Hopital Sud Rennes Rennes
France CHU de Rouen - Hôp. Charles NICOLLE Rouen
France CHU Saint-Etienne - Hôpital Nord Saint-Étienne
France Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre Strasbourg
France CHU Hôpital des Enfants Toulouse
France CHU TOURS - Hôpital Clocheville Tours
France CHU Nancy - Hôpital d'Enfants Vandoeuvre les Nancy
France Gustave Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with meaningful molecular genetic alterations Identification of molecular genetic alterations based on molecular characterisation of tumor at diagnosis, during patient treatment and follow-up (time dimension) At the end of study (6 years)
Primary Number of patients with meaningful immunological features Identification and characterisation of the tumor microenvironment and the host's immunological profile, at diagnosis and during patient treatment At the end of study (6 years)
Primary Number of patients with identification of new tumor-specific genetic characteristics during follow-up (clonal evolution) Comparison between genetic variations identified at diagnosis and those identified on circulating tumor DNA during treatment, FU and/or relapse up to 6 years
Secondary Correlation between disease recurrence and molecular and/or immunological biomarkers To characterise biomarkers, based on molecular analyses of tumour samples from diagnosis, for prognostic and predictive purposes.
To characterise the tumour microenvironment and the host's immunological profile, for prognostic and predictive purposes.
To identify potential prognostic and predictive biomarkers on samples collected during patient's treatment and follow-up, based on changes on circulating tumour DNA (ctDNA), detected by molecular biology techniques, and on immunological findings
up to 6 years
Secondary Correlation between genetic variations and immune parameters To compare molecular and immunological findings at diagnosis and during treatment (data integration) up to 6 years
Secondary Correlation between disease staging and immunological features To investigate the impact of the tumour microenvironment and host's immunological profile on the disease staging at diagnosis, by comparing patients with metastatic to patients with localised disease up to 6 years
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