NCT02666625

Brief Summary

The constitution of a biological samples bank, attached to epidemiological studies Cohort F-CCSS on iatrogenic effects of treatment of childhood cancer, will identify genetic variants that can modulate the iatrogenic risks of these treatments. The main objective is to provide a biological samples bank to consider, besides the carcinogenic risks, the risk of other iatrogenic diseases in these children, in particular cardiac, cerebrovascular, lung, bone and kidney. These conditions can be very incapacitating and in some cases, fatal. Their impact, however, is poorly estimated as occurring in adulthood, they are rarely made in relation to the treatment received in childhood. The overall project is expected to eventually better define the iatrogenic effects prevention strategies for cancer treatment.

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
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

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

December 1, 2010

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

7 years

First QC Date

August 3, 2015

Last Update Submit

June 8, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Study of genetic factors who might lead to secondary iatrogenic pathology due to treatment of a childhood cancer

    seven years

Study Arms (1)

Patients treated for cancer in childhood

Procedure: saliva samplesProcedure: blood samples

Interventions

Patients treated for cancer in childhood
blood samplesPROCEDURE
Patients treated for cancer in childhood

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated for a paediatric malignancies before the year 2000 having survived two years after treatment of solid tumor diagnosed before 18 years old

You may qualify if:

  • Patients treated for a first cancer in childhood
  • Adult patients
  • Signed informed consent
  • Patient insured or enjoying a social security scheme

You may not qualify if:

  • Minor patients
  • Under legal protection measure patients
  • Refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2015

First Posted

January 28, 2016

Study Start

December 1, 2010

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

June 9, 2016

Record last verified: 2016-06

Locations