Unicentric Retrospective Analysis of a Cohort of 602 Young Adult and Adolescent Patients (AJA), Aged 15 to 30 Years, With Haematological Malignancies, and Managed Between 2000 and 2016 (HEMAJA)

March 16, 2018 updated by: Institut Paoli-Calmettes
Unicentric retrospective analysis of a cohort of 602 young adult and adolescent patients, aged 15 to 30 years, with haematological malignancies, and managed between 2000 and 2016

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

The therapeutic results (response and survival) of young adult and adolescent patients with hematological malignancies are generally lower than those usually observed in adults over the age of 30, with equivalent treatment, particularly in lymphomatous pathology.The overall analysis of this large cohort of patients in its entirety, then by age groups (15-17 years, 18-25 years, 26-30 years) and pathology aims to describe the future of patients and patients. compare them to the results of the literature observed in this age group, and according to the therapeutic regimens administered (pediatric regimen or adult regimen).

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 (Actual)

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.
602

Contacts and Locations

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

Study Locations

  • France
    • Bouches Du Rhone
      • Marseille, Bouches Du Rhone, France, 13009
        • Institut Paoli Calmettes

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

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cohort of young adult patients and adolescents aged 15 to 30, carriers of hematological malignancies, and supported between 2000 and 2016

Description

Inclusion Criteria:

  • Malignant hemopathies (acute leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma) in primary care between 2000 and 2016.

Exclusion Criteria:

  • Not applicable

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.
15-17 years old
Drug: administered therapeutic regimens
administered therapeutic regimens
18-25 years old
Drug: administered therapeutic regimens
administered therapeutic regimens
26-30 years old
Drug: administered therapeutic regimens
administered therapeutic regimens
acute leukemia
Drug: administered therapeutic regimens
administered therapeutic regimens
non-Hodgkin's lymphoma
Drug: administered therapeutic regimens
administered therapeutic regimens
Hodgkin lymphoma
Drug: administered therapeutic regimens
administered therapeutic regimens
pediatric therapeutic regimen administered
Drug: administered therapeutic regimens
administered therapeutic regimens
adult therapeutic regimen administered
Drug: administered therapeutic regimens
administered therapeutic regimens
patients included in clinical trials
Drug: administered therapeutic regimens
administered therapeutic regimens
patients not included in clinical trials
Drug: administered therapeutic regimens
administered therapeutic regimens

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
Global Survival
Time Frame: 15 years
delay between the date of diagnosis and the date of the latest news
15 years
Survival without event
Time Frame: 15 years
delay between the date of diagnosis and an event (relapse, death, lost of follow-up)
15 years
Progression-free survival
Time Frame: 15 years
defined as the delay between the date of diagnosis and the date of relapse or death.
15 years

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
Epidemiological distribution by pathology compared to the adult population over 30 years
Time Frame: 1 day
Epidemiological distribution by pathology compared to the adult population over 30 years
1 day
Descriptive analysis of the characteristics of the disease at diagnosis by pathology
Time Frame: 15 years
Descriptive analysis of the characteristics of the disease at diagnosis by pathology
15 years
Descriptive analysis of treatments by pathology
Time Frame: 15 years
Descriptive analysis of treatments by pathology
15 years
Overall survival (OS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
Time Frame: 15 years
Overall survival (OS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
15 years
Event-free survival (EFS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
Time Frame: 15 years
Event-free survival (EFS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
15 years
Progression-free survival (PFS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
Time Frame: 15 years
Progression-free survival (PFS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
15 years
Long-term toxicity analysis (second cancers, fertility) for the global cohort and pathology.
Time Frame: 15 years
Long-term toxicity analysis (second cancers, fertility) for the global cohort and pathology.
15 years

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.
Institut Paoli-Calmettes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Diane COSO, Institut Paoli-Calmettes

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 (Actual)

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.
January 1, 2000

Primary Completion (Actual)

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.
December 31, 2016

Study Completion (Actual)

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.
December 31, 2016

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).
March 5, 2018

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.
March 16, 2018

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.
March 19, 2018

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.
March 19, 2018

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.
March 16, 2018

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.
March 1, 2018

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.
  • HEMAJA-IPC 2017-045

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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