NCT04450784

Brief Summary

Acute Myeloid Leukemias (AML) of the child are a rare disease and its prognosis varies according to the subgroup. Secondary AMLs remain a subgroup of poor prognosis, whose cytogenetic and molecular characteristics and prognostic value differ in part from de novo AMLs. The purpose of this national observatory is to record scientific and medical information on cases of secondary AML that have occurred in France since 2013 in order to improve the treatment of children and adolescents with this disease in the years to come. This national observatory will contribute to better knowledge and progress in research into these diseases.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

4 years

First QC Date

June 9, 2020

Last Update Submit

June 29, 2020

Conditions

Leukemia, Myeloid, Acute

Keywords

SecondaryAcute myeloid LeukemiaChildren

Outcome Measures

Primary Outcomes (17)

  • potential clinical-biological prognostic factors - patient characterics

    patient characteristics are sex, patient's age at the start of treatment for secondary AML, date of birth, personal history of genetic predisposition (including brittle diseases - see below), family history of cancers (1st or 2nd degree)

    through study completion, an average of 6 months

  • potential clinical-biological prognostic factors - first cancer characteristics

    First cancer characteristics are age of onset, determined from the date of diagnosis, and histology, determined by anatomo-pathological diagnosis.

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors :first cancer treatment : types of treatments received

    type of treatment: chemotherapy (Anthracyclines, Alkylating agents) and / or radiotherapy and/or Marrow autograft or allograft

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors - first cancer treatments: response to treatment

    response measured by bone marrow assessment using morphology and minimal residual disease (MRD) assessment : no response, partial response, complete remission

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors - first cancer treatments: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    nature, incidence and severity of adverse events (AEs)

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors - first cancer treatments: duration of treatment

    duration of treatment determined from the start and end dates

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors - first cancer treatments: cumulative dose received

    cumulative dose of each type of treatment received ( chemotherapy (Anthracyclines, Alkylating agents) and / or radiotherapy and/or Marrow autograft or allograft)

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors - secondary AML characteristics: date of diagnosis

    date of diagnosis

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors - secondary AML characteristics: median time of onset compared to the date of end of treatment for the 1st cancer

    median time of onset compared to the date of end of treatment for the 1st cancer

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors - secondary AML characteristics : hematological data assessed by morphology

    Leukocytes at diagnosis of secondary AML (G/L)

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors - secondary AML characteristics: cytogenetic data

    karyotype, exclusive and cumulative anomalies

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors - secondary AML characteristics: molecular data

    molecular data assessed by Next-Generation Sequencing panel

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors - secondary AML treatment: duration of treatment

    duration of treatment determined from the start and end dates

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors - secondary AML treatment: type of treatment

    chemotherapy received and bone marrow transplantation

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors - secondary AML treatment : response to treatment

    response measured by bone marrow assessment using morphology and minimal residual disease (MRD) assessment : no response, partial response, complete remission

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors - secondary AML treatment: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    nature, incidence and severity of adverse events (AEs)

    through study completion, an average of 6 months after patient inclusion

  • potential clinical-biological prognostic factors - Overall Survival (OS)

    Evaluated as time from diagnostic of the second AML to death from any cause or date last seen for patients who are alive at the end of the trial

    at the end of the 2 years of the inclusion period

Secondary Outcomes (5)

  • feasibility of setting up a French national database of secondary AMLs for children and adolescents - Number of cases included over the period

    at the end of the 2 years of the inclusion period

  • feasibility of setting up a French national database of secondary AMLs for children and adolescents - Missing Data

    at the end of the 2 years of the inclusion period

  • feasibility of setting up a French national database of secondary AMLs for children and adolescents - Centre participation rates

    at the end of the 2 years of the inclusion period

  • association of potential prognostic factors with event free survival and the occurrence of treatment-related toxicities- Recurrence of the disease

    at the end of the 2 years of the inclusion period

  • association of potential prognostic factors with event free survival and the occurrence of treatment-related toxicities- Treatment-related toxicities

    at the end of the 2 years of the inclusion period

Study Arms (1)

Secondary Acute Myeloid Leukemias (AML) of the child

Other: collection of the clinical and biological characteristics of secondary AMLs in children

Interventions

collection of the clinical and biological characteristics of secondary AMLs in childrenOTHER

to record scientific and medical information on cases of secondary Acute Myeloid Leukemias that have occurred in France since 2013

Secondary Acute Myeloid Leukemias (AML) of the child

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children and adolescents aged 0-18 years diagnosed with secondary AML

You may qualify if:

  • Patients aged 0-18 years
  • Patient with first cancer
  • Diagnosis of secondary AML
  • Patients treated in a SFCE (Société française des cancers de l'enfant) center
  • For cases included in the prospective from March 2019 onwards: Consent of holders of parental authority and consent of the child of understanding age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Stéphane S DUCASSOU, MD PhD

CONTACT

05 57 82 04 38stephane.ducassou@chu-bordeaux.fr

Aurore CAPELLI, PhD

CONTACT

05 57 82 08 77aurore.capelli@chu-bordeaux.fr

Study Design

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

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 30, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

July 1, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share