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

Leukemia, Myeloid, Acute Clinical Trial

— LEA-JA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02345915
• Other study ID #: LEA-JA-IPC 2014-005
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2014
• Last updated: September 1, 2017
• Start date: November 2014
• Est. completion date: May 2019

Study information

• Verified date: June 2017
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: 0033491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Lymphoid Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• Blood sample

• Electrocardiogram

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes	Aix Marseille Université

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Quality-of-life assessment of young adult acute leukemia-survivors	Quality of life questionnaire	24 mois
Secondary	Comparison of the frequency of sequelae between children/adolescents (LEA cohort) and young adults acute leukemia survivors (LEA-JA)		24 mois