Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia (LEA-JA)

September 1, 2017 updated by: Institut Paoli-Calmettes

Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia-LEA-JA-IPC 2014-005

Taking into account the specificities of adolescent and young adult cancer patients led agencies (in particular the French National Cancer Institute INCa, through the last Cancer Plan), to initiate projects targeting this population. Acute leukemia is among the most common cancers in adolescents and young adults. Recent therapeutic advances now allow hope for a cure in about 50% of this population. The issue of post-cancer is therefore of particular importance for young adults with cancer. Our aim is to establish the health determinants in young adult leukemia survivors and to compare the frequency of these effects and their explanatory factors to the data collected in children or adolescent leukemia survivors program (LEA). 90 patients followed up at the Institut Paoli-Calmettes cancer center and Nice University Hospital have been identified and would be included in this study.Collected data will include information on the initial disease and its treatments, physical sequelae (fertility, thyroid function, heart function, visual function, secondary tumors, viral infections, lung function, bone metabolism, iron metabolism, metabolic syndrome, osteonecrosis, alopecia ... ), quality of life, social and occupational integration and relationship with care system.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

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
      • Marseille, France, 13009
        • Recruiting
        • Institut Paoli-Calmettes
        • Principal Investigator:
          • Norbert VEY, MD PhD

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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Young adult (18-40 years) Leukemia survivor, in complete remission.
  • Acute leukemia diagnosed since January 1980 .
  • Patient Affiliated to social security or beneficiary
  • Signed Informed Consent prior to any screening procedures

Exclusion Criteria:

  • Emergency
  • Patient unable to abide by the study protocol (for geographical, social or psychological reasons)

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Young adult acute leukemia-survivor
Other: Blood sample
Other: Electrocardiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late sequelae evaluation of young adult acute leukemia-survivors
Time Frame: 24 mois
Main measured sequelae on: heart function, thyroid function, visual function, lung function, bone metabolism, secondary tumors, viral infections, iron metabolism, metabolic syndrome, gonadic, fertility, renal function, liver function,…
24 mois
Quality-of-life assessment of young adult acute leukemia-survivors
Time Frame: 24 mois
Quality of life questionnaire
24 mois

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of the frequency of sequelae between children/adolescents (LEA cohort) and young adults acute leukemia survivors (LEA-JA)
Time Frame: 24 mois
24 mois

Collaborators and Investigators

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

Sponsor

Institut Paoli-Calmettes

Collaborators

Aix Marseille Université

Investigators

  • Principal Investigator: Norbert VEY, MD PhD, 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)

November 1, 2014

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

January 19, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEA-JA-IPC 2014-005

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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