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

Study Overview
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Brief Summary
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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.

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

Conditions
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Leukemia, Myeloid, Acute, Acute Lymphoid Leukemia

Intervention / Treatment
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* Other: Blood sample
* Other: Electrocardiogram


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late sequelae evaluation of young adult acute leukemia-survivors | 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 | Quality of life questionnaire | 24 mois | 

Secondary Outcome Measures

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