Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia

Overview

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.

Full Title of Study: “Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia-LEA-JA-IPC 2014-005″

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2018

Interventions

  • Other: Blood sample
  • Other: Electrocardiogram

Arms, Groups and Cohorts

  • Other: Young adult acute leukemia-survivor

Clinical Trial Outcome Measures

Primary Measures

  • 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,…
  • Quality-of-life assessment of young adult acute leukemia-survivors
    • Time Frame: 24 mois
    • Quality of life questionnaire

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut Paoli-Calmettes
  • Collaborator
    • Aix Marseille Université
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Norbert VEY, MD PhD, Principal Investigator, Institut Paoli-Calmettes
  • Overall Contact(s)
    • Dominique GENRE, MD, 0033491223778, drci.up@ipc.unicancer.fr

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.