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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02345915
Other study ID # LEA-JA-IPC 2014-005
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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