Paediatric MalignanciesBIO-FNCT02666625
Iatrogenic Effects of Treatment for Childhood Cancer Constitution of a Biological Samples Bank
An observational study of Paediatric Malignancies, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paediatric Malignancies
- What is being tested?
- saliva samples and blood samples
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 3 sitesFrance
- Study dates
- 23 Jul 2013to Dec 2036
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients treated for a first cancer in childhood
- Adult patients
- Signed informed consent
- Patient insured or enjoying a social security scheme
Who cannot join
- Minor patients
- Under legal protection measure patients
- Refusal of consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Centre Léon Bérard
Lyon, 69008
Amandine Bertrand, MD, 0469166685, amandine.bertrand@lyon.unicancer.fr
- Recruiting
Institut Curie
Paris, 75005
François Doz, MD, 0144324550, francois.doz@curie.fr
- Recruiting
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805
Brice Fresneau, MD, 0142114622 ext. +33, brice.fresneau@gustaveroussy.fr
About this study
Official title: Study of Iatrogenic Effects of Treatment for Childhood Cancer - Constitution of a Biological Samples Bank as Part of a Cohort of Patients (Cohort FCCSS)
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.
- Conditions
- Paediatric Malignancies
- Being tested
- saliva samples, blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saliva samplesProcedure or surgery
blood samplesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients treated for cancer in childhood | Not described Receives: Procedure: saliva samples; Procedure: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of genetic factors who might lead to secondary iatrogenic pathology due to treatment of a childhood cancer
Measured: From enrollment to the end of study at 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start23 Jul 2013
- Primary completionDec 2036 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paediatric MalignanciesStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666625
- Sponsor's protocol ID
- 2010-A00555-34
- Other IDs
- 2010/1623
- Acronym
- BIO-F
- Status last verified
- Sep 2026
- First submitted
- 3 Aug 2015
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Iatrogenic Effects of Treatment for Childhood Cancer - Constitution of a Biological Samples Bank as Part of a Cohort of Patients (Cohort FCCSS)
- ClinicalTrials.gov ID
- NCT02666625
- Acronym / sponsor ID
- BIO-F / 2010-A00555-34
- Conditions
- Paediatric Malignancies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 23 Jul 2013 (actual)
- Primary completion
- Dec 2036 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated for cancer in childhood | – | Procedure: saliva samples, Procedure: blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Patients treated for a first cancer in childhood
- Adult patients
- Signed informed consent
- Patient insured or enjoying a social security scheme
Key exclusion criteria (3 listed)
- Minor patients
- Under legal protection measure patients
- Refusal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saliva samples | Procedure or surgery | Patients treated for cancer in childhood |
| blood samples | Procedure or surgery | Patients treated for cancer in childhood |
Primary outcome
Study of genetic factors who might lead to secondary iatrogenic pathology due to treatment of a childhood cancer
Time frame: From enrollment to the end of study at 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paediatric Malignancies, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brice Fresneau, MD (0142114622 ext. +33, brice.fresneau@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of genetic factors who might lead to secondary iatrogenic pathology due to treatment of a childhood cancer (time frame: From enrollment to the end of study at 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.