NCT02345915

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

September 5, 2017

Status Verified

June 1, 2017

Enrollment Period

3.5 years

First QC Date

December 5, 2014

Last Update Submit

September 1, 2017

Conditions

Leukemia, Myeloid, AcuteAcute Lymphoid Leukemia

Outcome Measures

Primary Outcomes (2)

  • 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

  • Quality-of-life assessment of young adult acute leukemia-survivors

    Quality of life questionnaire

    24 mois

Secondary Outcomes (1)

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

    24 mois

Study Arms (1)

Young adult acute leukemia-survivor

OTHER
Other: Blood sampleOther: Electrocardiogram

Interventions

Blood sampleOTHER
Young adult acute leukemia-survivor
ElectrocardiogramOTHER
Young adult acute leukemia-survivor

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Emergency
  • Patient unable to abide by the study protocol (for geographical, social or psychological reasons)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13009, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Norbert VEY, MD PhD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique GENRE, MD

CONTACT

0033491223778drci.up@ipc.unicancer.fr

Jihane Pakradouni, PharmD PhD

CONTACT

0033491223778drci.up@ipc.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2014

First Posted

January 26, 2015

Study Start

November 1, 2014

Primary Completion

May 1, 2018

Study Completion

May 1, 2019

Last Updated

September 5, 2017

Record last verified: 2017-06

Locations

FR(1)