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