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

NCT ID: NCT02345915

Last Updated: 2017-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2019-05-31

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.

Detailed Description

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Conditions

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Leukemia, Myeloid, Acute Acute Lymphoid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Young adult acute leukemia-survivor

Group Type OTHER

Blood sample

Intervention Type OTHER

Electrocardiogram

Intervention Type OTHER

Interventions

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Blood sample

Intervention Type OTHER

Electrocardiogram

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aix Marseille Université

OTHER

Sponsor Role collaborator

Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Norbert VEY, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

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Institut Paoli-Calmettes

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Dominique GENRE, MD

Role: CONTACT

0033491223778

Jihane Pakradouni, PharmD PhD

Role: CONTACT

0033491223778

Facility Contacts

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Dominique Genre, MD

Role: primary

0033491223778

Other Identifiers

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LEA-JA-IPC 2014-005

Identifier Type: -

Identifier Source: org_study_id

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