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Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia (LEA-JA)

Primary Purpose

Leukemia, Myeloid, Acute, Acute Lymphoid Leukemia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Electrocardiogram
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Leukemia, Myeloid, Acute

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • Institut Paoli-CalmettesRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Young adult acute leukemia-survivor

Arm Description

Outcomes

Primary Outcome Measures

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,…
Quality-of-life assessment of young adult acute leukemia-survivors
Quality of life questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
December 5, 2014
Last Updated
September 1, 2017
Sponsor
Institut Paoli-Calmettes
Collaborators
Aix Marseille Université
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1. Study Identification

Unique Protocol Identification Number
NCT02345915
Brief Title
Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia
Acronym
LEA-JA
Official Title
Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia-LEA-JA-IPC 2014-005
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
Collaborators
Aix Marseille Université

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute, Acute Lymphoid Leukemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Young adult acute leukemia-survivor
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Type
Other
Intervention Name(s)
Electrocardiogram
Primary Outcome Measure Information:
Title
Late sequelae evaluation of young adult acute leukemia-survivors
Description
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,…
Time Frame
24 mois
Title
Quality-of-life assessment of young adult acute leukemia-survivors
Description
Quality of life questionnaire
Time Frame
24 mois
Secondary Outcome Measure Information:
Title
Comparison of the frequency of sequelae between children/adolescents (LEA cohort) and young adults acute leukemia survivors (LEA-JA)
Time Frame
24 mois

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique GENRE, MD
Phone
0033491223778
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jihane Pakradouni, PharmD PhD
Phone
0033491223778
Email
drci.up@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert VEY, MD PhD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Genre, MD
Phone
0033491223778
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Norbert VEY, MD PhD

12. IPD Sharing Statement

Learn more about this trial

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

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