CancerSALTONCT01531478
Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France
An observational study of Cancer and Sequels, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
Trial summary
Childhood cancers are rare, and today 75% of patients survive them. An estimated one out of 850 French persons has survived childhood cancer. However, the complications of chemotherapy, radiotherapy or surgery can lead to a higher risk of secondary mortality, which the literature estimates is at 14%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Sequels, Complications
- What is being tested?
- Unique medical visit of the study
- How many people
- 147 participants
- Where
- 4 sitesFrance
- Study dates
- May 2011to Dec 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective cohort study in non-leukemia cancer survivors diagnosed between 1987 and 1992 in the Rhône-Alpes and Auvergne regions of France, who were younger than 15 years at the time of diagnosis
Who may be able to join
- Having been diagnosed with cancer between 01/01/1987 and 31/12/1992, before age 15, and living in Auvergne or Rhône-Alpes (France)
- Being a beneficiary of health insurance
- Having signed the informed consent form
Who cannot join
- Having been diagnosed with leukemia as a primary cancer
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
CHU de Grenoble
Grenoble, 38000
IHOP
Lyon, 69000
CHU de Saint-Etienne
Saint-Etienne, 42000
About this study
Childhood cancers are rare, and today 75% of patients survive them. An estimated one out of 850 French persons has survived childhood cancer. However, the complications of chemotherapy, radiotherapy or surgery can lead to a higher risk of secondary mortality, which the literature estimates is at 14%. Regular care has a positive impact on the quality of life and health of adults who survived cancer during their childhoods. It aims to detect the potential long-lasting effects of cancer and to provide therapeutic education and psychological care. Thanks to cancer registries, several countries (USA, Canada, UK, Germany, the Netherlands) have developed long-term care structures which function with specially trained adult medicine practitioners. There are only two structures in France: the Long-Term Oncology/Hematology Follow-Up Clinic, headed by Dr François Pein, in Nantes (France), and the LEA program for the follow-up of children treated for leukemia in the PACA-Corse and Lorraine regions of France, which began in 2003 and has since been extended to other centers.
The Rhône-Alpes and Auvergne regions have had childhood cancer registries since 1987; they compile about 200 new cases a year. The Rhône-Alpes registry has conducted a preliminary trial on children (0-15 years old) diagnosed with cancer between 1987 and 1992. They analyzed the correlation between patients' quality of life and the long-term medical effect of cancer and treatment, both recorded in patients' medical files and declared by patients. These young adults who survived pediatric cancer appear to suffer from and declare many complications, although this does not impact their global quality of life much. There is a negative correlation between the number of complications (observed or declared) and the global quality of life score, but only three types of complications play a significant role (motor function complications, auditory complications, and alopecia.) In addition, there is a significant mismatch between patients's perceived health (what they say they experience), and the information contained in their medical files. These young adults expressed the need for their impressions to be better taken into account by health care professionals. This study does not assess patients' psychopathological characteristics.
Read the detailed description
Results will help identify long-term complications, respond to patients' expectations, and evaluate the feasibility of conducting such a follow-up in all patients. They should guide the choice of the most appropriate tools for care, help assess needs in terms of collaboration with adult care staff, and identify potential partners.
- Conditions
- Cancer, Sequels, Complications
- Being tested
- Unique medical visit of the study
- Keywords
- Childhood cancer, Cancer, Sequels, Complications, Chemotherapy, Radiotherapy, Surgery
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unique medical visit of the studyOther
The visit will be with an oncologist specialized in the long-term follow-up of cured pediatric cancer patients. The examination will consist in weight and height measurements, a clinical examination and a measurement of arterial pressure. The list of drugs taken in the last two years, as well as all health issues encountered since the cancer treatment, will be collected. Success in education, career and, family status will also be discussed.
After the medical examination, patients will be offered a visit with a psychologist in order to assess their psychopathological outcomes. This questionnaire is a interquestionnaire designed to screen axis I psychopathological conditions. It includes an evaluation of all types of risk-taking behavior (alcohol, drugs, anorexia and bulimia).
| Study group | Role | What they receive |
|---|---|---|
| Young adult survivors of childhood cancer | Young adult survivors of childhood cancer diagnosed between 1987 and 1992 in the Rhône-Alpes and Auvergne regions of France. Receives: Other: Unique medical visit of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical complications (post cancer treatment)
The investigators note the medical complications from the end of their cancer treatment to the inclusion visit. Theses complications depend on the type of treatment received.
Measured: 15 years after the end of the cancer treatment
Secondary outcomes (1)
MINI questionnaire score
The investigators measured the psychological complications (post cancer treatment) by MINI questionnaire score.
Measured: 15 years after the end of the cancer treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startMay 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Claire BERGER, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531478
- Sponsor's protocol ID
- 1008102
- Other IDs
- 2010-A00853-36
- Acronym
- SALTO
- Status last verified
- Mar 2015
- First submitted
- 20 Jul 2011
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tardy F, Casagranda L, Protiere A, Buisson-Papet G, Garcin A, Trombert-Paviot B, Freycon C, Marec-Berard P, Massoubre C, Berger C. Long-Term Clinical and Psychiatric Complications of Young Adults Cured of a Pediatric Bone Tumor Diagnosed Between 1987 and 1999 in Rhone: Alpes Region (France). J Adolesc Young Adult Oncol. 2022 Dec;11(6):571-579. doi: 10.1089/jayao.2021.0145. Epub 2022 Jan 18.
PubMed 35049375
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France
- ClinicalTrials.gov ID
- NCT01531478
- Acronym / sponsor ID
- SALTO / 1008102
- Conditions
- Cancer, Sequels, Complications
- Keywords
- Childhood cancer, Cancer, Sequels, Complications, Chemotherapy, Radiotherapy, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- May 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Feb 2012 (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.
Childhood cancers are rare, and today 75% of patients survive them. An estimated one out of 850 French persons has survived childhood cancer. However, the complications of chemotherapy, radiotherapy or surgery can lead to a higher risk of secondary mortality, which the literature estimates is at 14%. Regular care has a positive impact on the quality of life and health of adults who survived cancer during their childhoods. It aims to detect the potential long-lasting effects of cancer and to provide therapeutic education and psychological care. Thanks to cancer registries, several countries (USA, Canada, UK, Germany, the Netherlands) have developed long-term care structures which function with specially trained adult medicine practitioners. There are only two structures in France: the Long-Term Oncology/Hematology Follow-Up Clinic, headed by Dr François Pein, in Nantes (France), and the LEA program for the follow-up of children treated for leukemia in the PACA-Corse and Lorraine regions of France, which began in 2003 and has since been extended to other centers.
The Rhône-Alpes and Auvergne regions have had childhood cancer registries since 1987; they compile about 200 new cases a year. The Rhône-Alpes registry has conducted a preliminary trial on children (0-15 years old) diagnosed with cancer between 1987 and 1992. They analyzed the correlation between patients' quality of life and the long-term medical effect of cancer and treatment, both recorded in patients' medical files and declared by patients. These young adults who survived pediatric cancer appear to suffer from and declare many complications, although this does not impact their global quality of life much. There is a negative correlation between the number of complications (observed or declared) and the global quality of life score, but only three types of complications play a significant role (motor function complications, auditory complications, and alopecia.) In addition, there is a significant mismatch between patients's perceived health (what they say they experience), and the information contained in their medical files. These young adults expressed the need for their impressions to be better taken into account by health care professionals. This study does not assess patients' psychopathological characteristics.
Detailed description
Results will help identify long-term complications, respond to patients' expectations, and evaluate the feasibility of conducting such a follow-up in all patients. They should guide the choice of the most appropriate tools for care, help assess needs in terms of collaboration with adult care staff, and identify potential partners.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young adult survivors of childhood cancer | – | Other: Unique medical visit of the studyYoung adult survivors of childhood cancer diagnosed between 1987 and 1992 in the Rhône-Alpes and Auvergne regions of France. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective cohort study in non-leukemia cancer survivors diagnosed between 1987 and 1992 in the Rhône-Alpes and Auvergne regions of France, who were younger than 15 years at the time of diagnosis
Key inclusion criteria (3 listed)
- Having been diagnosed with cancer between 01/01/1987 and 31/12/1992, before age 15, and living in Auvergne or Rhône-Alpes (France)
- Being a beneficiary of health insurance
- Having signed the informed consent form
Key exclusion criteria (1 listed)
- Having been diagnosed with leukemia as a primary cancer
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 |
|---|---|---|
| Unique medical visit of the studyThe visit will be with an oncologist specialized in the long-term follow-up of cured pediatric cancer patients. The examination will consist in weight and height measurements, a clinical examination and a measurement of arterial pressure. The list of drugs taken in the last two years, as well as all health issues encountered since the cancer treatment, will be collected. Success in education, career and, family status will also be discussed. After the medical examination, patients will be offered a visit with a psychologist in order to assess their psychopathological outcomes. This questionnaire is a interquestionnaire designed to screen axis I psychopathological conditions. It includes an evaluation of all types of risk-taking behavior (alcohol, drugs, anorexia and bulimia). | Other | Young adult survivors of childhood cancer |
Primary outcome
Medical complications (post cancer treatment)
Time frame: 15 years after the end of the cancer treatment
The investigators note the medical complications from the end of their cancer treatment to the inclusion visit. Theses complications depend on the type of treatment received.
1 secondary outcome
MINI questionnaire score
Time frame: 15 years after the end of the cancer treatment
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 31 Mar 2015.
- Derived from this study: PubMed 35049375Tardy F, Casagranda L, Protiere A, Buisson-Papet G, Garcin A, Trombert-Paviot B, Freycon C, Marec-Berard P, Massoubre C, Berger C. Long-Term Clinical and Psychiatric Complications of Young Adults Cured of a Pediatric Bone Tumor Diagnosed Between 1987 and 1999 in Rhone: Alpes Region (France). J Adolesc Young Adult Oncol. 2022 Dec;11(6):571-579. doi: 10.1089/jayao.2021.0145. Epub 2022 Jan 18.
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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.
Claire BERGER, MD principal investigator
CHU 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 Cancer and Sequels, 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 3 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 31 Mar 2015. 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?
Medical complications (post cancer treatment) (time frame: 15 years after the end of the cancer treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01531478, which also lists 1 linked publication.
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 31 Mar 2015.