ObServatory Children Acute RElated Therapy Leukemia (OSCARE)

June 29, 2020 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Therapy-related myeloid neoplasms (t-MNs) are a group of hematologic diseases that arise after chemotherapy and/or radiation therapy for a previous cancer or rarely autoimmune diseases. t-MNs had been included in the group of AMLs and remain as a distinct category also in the recent 2016 revision of the WHO classification of myeloid neoplasm and acute leukemia. The latency between exposition to anticancer drugs and development of t-MN may vary from some months up to 10 years, even considering the age at diagnosis of the primary malignancy, the kind of cytotoxic treatment previously used, and the cumulative dose and dose intensity. The prognosis of s-AML is generally considered to be poorer than that of de novo AML. The disease tends to be refractory to chemotherapy, and patients' tolerance of treatment generally is reduced because of prior therapies. 5-year event-free survival (EFS) and overall survival (OS) rates of pediatric t-AML/t-MDS have been reported to be 14% to 30%. However, the results are conflicting and overall lacking when compared with those in adults. The purpose of this national observatory is to record scientific and medical information on cases of secondary Acute Myeloid Leukemias 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. The primary objective is to evaluate the association of potential prognostic factors (including clinical-biological factors) with the overall survival of children and adolescents aged 0-18 years diagnosed with secondary AML. The secondary objectives are to test the feasibility of setting up a French national database of secondary AMLs for children and adolescents as a first step towards European implementation, to assess the association of potential prognostic factors with event free survival and the occurrence of treatment-related toxicities, to characterize the molecular abnormalities associated with secondary AMLs in children and adolescents.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria: None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Secondary Acute Myeloid Leukemias (AML) of the child
Other: collection of the clinical and biological characteristics of secondary AMLs in children
to record scientific and medical information on cases of secondary Acute Myeloid Leukemias that have occurred in France since 2013

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
potential clinical-biological prognostic factors - patient characterics
Time Frame: through study completion, an average of 6 months
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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
Time Frame: through study completion, an average of 6 months after patient inclusion
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)
Time Frame: at the end of the 2 years of the inclusion period
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
feasibility of setting up a French national database of secondary AMLs for children and adolescents - Number of cases included over the period
Time Frame: at the end of the 2 years of the inclusion period
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
Time Frame: at the end of the 2 years of the inclusion period
Proportion and type of missing data in the database after the base freeze
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
Time Frame: at the end of the 2 years of the inclusion period
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
Time Frame: at the end of the 2 years of the inclusion period

Recurrence of the disease : Relapse criteria (in a patient who has had complete remission):

≥ 5% blasts in the bone marrow (not attributable to post chemotherapy regeneration)
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
Time Frame: at the end of the 2 years of the inclusion period
Treatment-related toxicities : Metabolic / endocrine complications in particular: growth retardation, hypothyroidism, gonadal insufficiency; Organic complications, in particular: renal failure, heart failure, respiratory failure ; Graft versus host reaction (GvH)
at the end of the 2 years of the inclusion period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2018/31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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