Biological Characterisation of High Risk CHildhood Cancer in Children, Adolescents and Young Adults (MICCHADO)

Leukemia Clinical Trial

— MICCHADO  

Official title:

Molecular and Immunological Characterisation of High Risk CHildhood Cancer At DiagnOsis, Treatment and Follow-up - Biological Evaluation in Children, Adolescents and Young Adults -

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03496402
• Other study ID #: IC 2017-02
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Central Nervous System Tumor
• Ewing Sarcoma Family of Tumors
• Leukemia
• Nervous System Neoplasms
• Neuroblastoma
• Osteosarcoma
• Rhabdomyosarcoma
• Sarcoma, Ewing

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