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Clinical Trials/NCT02345915
NCT02345915
Unknown
Not Applicable

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

Institut Paoli-Calmettes1 site in 1 country90 target enrollmentNovember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leukemia, Myeloid, Acute
Sponsor
Institut Paoli-Calmettes
Enrollment
90
Locations
1
Primary Endpoint
Quality-of-life assessment of young adult acute leukemia-survivors
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
May 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Institut Paoli-Calmettes
Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Quality-of-life assessment of young adult acute leukemia-survivors

Time Frame: 24 mois

Quality of life questionnaire

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,...

Secondary Outcomes

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

Study Sites (1)

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