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

Not Applicable

• Conditions: Acute Lymphoid Leukemia; Leukemia, Myeloid, Acute
• Interventions: Other: Blood sample; Other: Electrocardiogram

• Registration Number: NCT02345915
• Lead Sponsor: Institut Paoli-Calmettes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2015-01-19
• Study First Posted: 2015-01-26
• Status Verified: 2017-06
• Last Update Submitted: 2017-09-01
• Last Update Posted: 2017-09-05
• Primary Completion: 2018-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Young adult acute leukemia-survivor	Blood sample	-
Young adult acute leukemia-survivor	Electrocardiogram	-

Primary Outcome Measures

Name	Time	Method
Quality-of-life assessment of young adult acute leukemia-survivors	24 mois	Quality of life questionnaire
Late sequelae evaluation of young adult acute leukemia-survivors	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 Outcome Measures

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

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, France