Pediatric CancerSALTO-BIONCT02665819
Long Term Support for Pediatric Cancer Adult Survivors in Rhône-Alpes : Evaluation of Women Fertility.
An observational study of Pediatric Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
Trial summary
PanCareLIFE Study is a cohort study of patients treated for cancer in childhood, and biological case-control study nested in the cohort (WP4) is coordinated by Erasmus MC-Sophia Children's Hospital in Holland. Ensure optimal patient quality of life throughout his life is a priority for the research teams. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Pediatric cancer women survivors
- How many people
- 101 participants
- Where
- 4 sitesFrance
- Study dates
- 23 Oct 2015to 29 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The population studied belongs to a cohort composed of women treated for a cancer in their childhood (diagnosed between 1987 and 1999 in Rhône-Alpes Region) before 15 years old.
Who may be able to join
- min 18 years old
- female
- diagnosed for a cancer between 01/01/87 and 31/12/99, before 15 years old, and living in Rhône-Alpes
- treated with chemotherapy +/- radiotherapy
- accepting a blood taking to perform DNA and hormonal tests
- affiliated to a security social scheme
- informed consent
Who cannot join
- severe mental disorder
Trial locations and contacts
4 sites in 1 country.
France4 sites
Chu Grenoble
Grenoble, 38000
IHOP 1 Lyon
Lyon, 69000
CH Lyon Sud
Pierre-Bénite, 69000
CHU Saint-Etienne
Saint-Etienne, 42000
About this study
Official title: SALTO-BIO (Long Term Follow up in Oncology) - PanCareLIFE. Long Term Support for Pediatric Cancer Survivors in Rhône-Alpes. Evaluation of Women Fertility.
PanCareLIFE Study is a cohort study of patients treated for cancer in childhood, and biological case-control study nested in the cohort (WP4) is coordinated by Erasmus MC-Sophia Children's Hospital in Holland.
Ensure optimal patient quality of life throughout his life is a priority for the research teams. PanCareLIFE Study also aims to identify the factors that predispose to impaired quality of life. It is in this light that will be offered to patients a quality of life questionnaires during the period of treatment and then periodically during long-term follow-up.
Read the detailed description
PanCareLIFE Study is a cohort study of patients treated for cancer in childhood, and biological case-control study nested in the cohort (WP4) is coordinated by Erasmus MC-Sophia Children's Hospital in Holland. At European level, approximately 1,200 women are expected in this latest study, the patients were already identified through certain regional or national registries in terms of cumulative doses of chemotherapy, surgery, radiation.
Ensure optimal patient quality of life throughout his life is a priority for the research teams. PanCareLIFE Study also aims to identify the factors that predispose to impaired quality of life. It is in this light that will be offered to former patients to complete quality of life questionnaires during the period of treatment and then periodically during long-term follow-up.
The SALTO-BIO study is the French part of the European study PanCareLIFE. CHU of Saint-Etienne as French promotor, will organize this study only on the Rhône-Alpes region (Lyon, Grenoble and Saint-Etienne centers) and will participate as co-investigator and "data provider "to WP2, WP3, WP4 and WP6. Indeed, ototoxicity is already studied by a French group.
- Conditions
- Pediatric Cancer
- Being tested
- Pediatric cancer women survivors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric cancer women survivorsOther
Women will incur a blood taking to obtain fertility indication.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric cancer women survivors | Women diagnosed for a cancer between 01/01/87 and 31/12/99 before the age of 15 years old living in Rhône-Alpes, will incur a blood taking for DNA tests (hormone tests) to see their fertility capacity. Receives: Other: Pediatric cancer women survivors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the FSH hormone rate.
In this arm women will incur a blood taking to measure the FSH hormone rate.
Measured: Day 1
Measure the AMH hormone rate.
In this arm women will incur a blood taking to measure the AMH hormone rate.
Measured: Day 1
Detect the genetic polymorphism of the FSH and AMH hormones.
With the blood taking realized for each patient, genetic markers will be obtained to identify their fertility capacity.
Measured: Day 1
Secondary outcomes (2)
Quality of life
The quality of life for each patient will be measured with the SF-36 scale.
Measured: Day 1
Identification of new loci associated to ovarian toxicity
With a pan-genomic method, new loci (associated to ovarian toxicity) will be identified.
Measured: Day 1
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 Oct 2015
- Primary completion29 Nov 2016
- Study completion29 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERGER Claire, MD, Principal investigator, Centre Hospitalier Universitaire de Saint EtienneLéonie CASAGRANDA, PhD, Study chair, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665819
- Sponsor's protocol ID
- 1508057
- Other IDs
- 2015-A00667-42
- Acronym
- SALTO-BIO
- Status last verified
- Feb 2018
- First submitted
- 25 Jan 2016
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SALTO-BIO (Long Term Follow up in Oncology) - PanCareLIFE. Long Term Support for Pediatric Cancer Survivors in Rhône-Alpes. Evaluation of Women Fertility.
- ClinicalTrials.gov ID
- NCT02665819
- Acronym / sponsor ID
- SALTO-BIO / 1508057
- Conditions
- Pediatric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 23 Oct 2015 (actual)
- Primary completion
- 29 Nov 2016 (actual)
- Study completion
- 29 Nov 2016 (actual)
- 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.
PanCareLIFE Study is a cohort study of patients treated for cancer in childhood, and biological case-control study nested in the cohort (WP4) is coordinated by Erasmus MC-Sophia Children's Hospital in Holland.
Ensure optimal patient quality of life throughout his life is a priority for the research teams. PanCareLIFE Study also aims to identify the factors that predispose to impaired quality of life. It is in this light that will be offered to patients a quality of life questionnaires during the period of treatment and then periodically during long-term follow-up.
Detailed description
PanCareLIFE Study is a cohort study of patients treated for cancer in childhood, and biological case-control study nested in the cohort (WP4) is coordinated by Erasmus MC-Sophia Children's Hospital in Holland. At European level, approximately 1,200 women are expected in this latest study, the patients were already identified through certain regional or national registries in terms of cumulative doses of chemotherapy, surgery, radiation.
Ensure optimal patient quality of life throughout his life is a priority for the research teams. PanCareLIFE Study also aims to identify the factors that predispose to impaired quality of life. It is in this light that will be offered to former patients to complete quality of life questionnaires during the period of treatment and then periodically during long-term follow-up.
The SALTO-BIO study is the French part of the European study PanCareLIFE. CHU of Saint-Etienne as French promotor, will organize this study only on the Rhône-Alpes region (Lyon, Grenoble and Saint-Etienne centers) and will participate as co-investigator and "data provider "to WP2, WP3, WP4 and WP6. Indeed, ototoxicity is already studied by a French group.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric cancer women survivors | – | Other: Pediatric cancer women survivorsWomen diagnosed for a cancer between 01/01/87 and 31/12/99 before the age of 15 years old living in Rhône-Alpes, will incur a blood taking for DNA tests (hormone tests) to see their fertility capacity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population studied belongs to a cohort composed of women treated for a cancer in their childhood (diagnosed between 1987 and 1999 in Rhône-Alpes Region) before 15 years old.
Key inclusion criteria (7 listed)
- min 18 years old
- female
- diagnosed for a cancer between 01/01/87 and 31/12/99, before 15 years old, and living in Rhône-Alpes
- treated with chemotherapy +/- radiotherapy
- accepting a blood taking to perform DNA and hormonal tests
Key exclusion criteria (1 listed)
- severe mental disorder
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 |
|---|---|---|
| Pediatric cancer women survivorsWomen will incur a blood taking to obtain fertility indication. | Other | Pediatric cancer women survivors |
Primary outcome
Measure the FSH hormone rate.
Time frame: Day 1
In this arm women will incur a blood taking to measure the FSH hormone rate.
Measure the AMH hormone rate.
Time frame: Day 1
In this arm women will incur a blood taking to measure the AMH hormone rate.
Detect the genetic polymorphism of the FSH and AMH hormones.
Time frame: Day 1
With the blood taking realized for each patient, genetic markers will be obtained to identify their fertility capacity.
2 secondary outcomes
Quality of life
Time frame: Day 1
Identification of new loci associated to ovarian toxicity
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
BERGER Claire, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
Léonie CASAGRANDA, PhD study chair
Centre Hospitalier Universitaire de Saint Etienne
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 4 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 7 inclusion and 1 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: finished, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the FSH hormone rate. (time frame: Day 1). The study lists 3 primary outcomes in all. 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 20 Feb 2018.