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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

Institut Paoli-Calmettes

Investigators

  • 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)

January 1, 2000

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Hodgkin Lymphoma

Clinical Trials on administered therapeutic regimens

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe