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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02345915

Acronym

LEA-JA

Enrollment

Registered

2015-01-26

Start date

2014-11-30

Completion date

2019-05-31

Last updated

2017-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoid Leukemia, Leukemia, Myeloid, Acute

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.

Interventions

OTHERBlood sample

OTHERElectrocardiogram

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 30 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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,…
Quality-of-life assessment of young adult acute leukemia-survivors	24 mois	Quality of life questionnaire

Secondary

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

Countries

France

Contacts

Primary ContactDominique GENRE, MD

drci.up@ipc.unicancer.fr0033491223778

Backup ContactJihane Pakradouni, PharmD PhD