Childhood CancerGECCOSNCT04702321
Genetic Risks for Childhood Cancer Complications in Switzerland
An observational study of Childhood Cancer and Genetic Predisposition, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The objectives of the GECCOS project are to identify genetic variants associated with complications of childhood cancer using genotype-phenotype association studies. Germline genetic samples and data of the "Germline DNA Biobank for Childhood Cancer and Blood Disorders Switzerland" (BISKIDS) which is included in the… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Childhood Cancer, Genetic Predisposition, Late Effect
- What is being tested?
- Procedure: Biospecimen Collection and Procedure: Medical Chart Review
- How many people
- 6,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2020to 31 Dec 2037
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Brief description of the anticipated study population: Swiss childhood cancer patients and survivors are being invited to participate in the BaHOP biobank hosting the Germline DNA Biobank for Childhood Cancer and Blood Disorders Switzerland (BISKIDS). Recruitment for BISKIDS is done by the collaborators at the Institute of Social and Preventive Medicine (ISPM), University of Bern. As of December 2019, 9,306 persons were alive and eligible to participate in this project. Participants are invited in batches depending on inclusion criteria of specific sub-projects. Clinical data is collected at the ISPM for childhood cancer patients and survivors since 1976 which will be available for the GECCOS project for genotype-phenotype analysis.
Who may be able to join
- Registered in the Swiss Childhood Cancer Registry (SCCR) since 1976; AND
- consented to the BaHOP (host biobank for the BISKIDS Biobanking project); AND
- diagnosed with cancer according to the International Classification of Childhood Cancer, version 3, ICCC-3, or Langerhans cell histiocytosis (LCH) before age 21 years.
Who cannot join
- Lacking written consent signed by participant and/ or their legal representative to participate in the BaHOP (where applicable); OR
- died after study participation and declined use of their samples and data after their death in the original consent for BaHOP (as indicated on the BaHOP consent).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Geneva
Geneva, 1211
Marc Ansari, Prof, +41 79 553 61 00, Marc.Ansari@hcuge.ch
Nicolas Waespe, MD, +41 77 435 37 95, biskids@cansearch.ch
About this study
The objectives of the GECCOS project are to identify genetic variants associated with complications of childhood cancer using genotype-phenotype association studies. Germline genetic samples and data of the "Germline DNA Biobank for Childhood Cancer and Blood Disorders Switzerland" (BISKIDS) which is included in the Geneva Biobank for Hematology and Oncology in Pediatrics (BaHOP) will be used with clinical data of Swiss childhood cancer patients collected at the Institute of Social and Preventive Medicine in Bern.
Read the detailed description
Background and rationale :
Around 300 children and adolescents are diagnosed with cancer each year in Switzerland. A wide range of acute and chronic complications have been linked to cancer and its treatments. Cancer treatments, though highly curative, have a high incidence of adverse events, not only acutely but also chronically. Depending on the type and dose of treatments, the complications vary. There are important inter-individual differences in the type and severity of complications associated with similar cancer treatments. Genetic variation was identified to affect some complications and is suspected to play an important role in many of these differences.
The GECCOS project on analysis of genetic risks for complications associated with childhood cancers fills the gap to analyze germline genetic data with clinical information on short- and long-term complications. This has not been done on a nationwide scale in Switzerland yet. The GECCOS project will improve knowledge on germline genetic risks for complications and further personalize care during acute treatment and follow-up of childhood cancer patients.
Objectives:
Primary objectives:
- Identify genetic variants associated with complications after childhood cancer leading to specific organ dysfunctions and second primary neoplasms.
- Evaluate the functional importance of genetic variants for complications after childhood cancer through in silico and in vitro studies.
Secondary objective:
Assess genetic variants and their impact on multiple outcomes as a result of specific treatment exposures.
- Conditions
- Childhood Cancer, Genetic Predisposition, Late Effect
- Being tested
- Procedure: Biospecimen Collection, Procedure: Medical Chart Review
- Keywords
- Childhood cancer, Late effects, Therapy complications, Second neoplasm, Registry, Biobank, Genetic variation, Genetic polymorphism, Pharmacogenetics, Genetic association studies
- Medical subject headings
- Neoplasms, Genetic Predisposition to Disease, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: Biospecimen CollectionOther
Also called Medical Chart Review
Collection of saliva, buccal swabs, blood, or other sample adequate for germline DNA extraction
Procedure: Medical Chart ReviewOther
Also called Registry data collection
Collection of clinical data
| Study group | Role | What they receive |
|---|---|---|
| Patient cohort | Patients with clinical data and biospecimens Receives: Other: Procedure: Biospecimen Collection; Other: Procedure: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic variants in participants as a possible marker of risk of complications after childhood cancer
Genotyping of germline genetic variants (candidate gene, whole exome, or whole genome sequencing data)
Measured: Genetic sequencing performed at enrollment into study
Secondary outcomes (2)
Number of participants with complications of childhood cancers: specific organ dysfunctions assessed by objective measurements and second primary neoplasms, extracted from medical records and cancer registry information
- Specific organ dysfunctions assessed by objective measurements, e.g. audiograms for hearing loss, and self-assessment with questionnaires and
- Second primary neoplasms as defined by the International Agency for Research on Cancer (IARC) criteria
Measured: Data collection at enrollment into study, and longitudinal data collection until last follow-up or death from any cause, approx. 10 years
Demographic and clinical covariates corresponding to possible risk factors for specific complications after childhood cancer, extracted from medical records and cancer registry information
Covariates include but are not restricted to the collection of the following data:
- demographic information, e.g. sex, age and year at diagnosis, etc.
- cancer-related information, e.g. cancer type, stage, metastases, etc.
- treatment-related risk factors, e.g. platinum chemotherapy exposure (with cumulative dose, mg/m2) for hearing impairment, radiation dose (gray) and fields for radiation toxicity, etc.
Measured: Data collection at enrollment into study, and longitudinal data collection until last follow-up or death from any cause, approx. 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Dec 2020
- Primary completion31 Dec 2037 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Other
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Ansari, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702321
- Sponsor's protocol ID
- GECCOS
- Acronym
- GECCOS
- Status last verified
- Jan 2021
- First submitted
- 21 Dec 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon specific request to study PI (Marc.Ansari@hcuge.ch or: biskids@cansearch.ch)
Publications
Waespe N, Strebel S, Nava T, Uppugunduri CRS, Marino D, Mattiello V, Otth M, Gumy-Pause F, Von Bueren AO, Baleydier F, Mader L, Spoerri A, Kuehni CE, Ansari M. Cohort-based association study of germline genetic variants with acute and chronic health complications of childhood cancer and its treatment: Genetic Risks for Childhood Cancer Complications Switzerland (GECCOS) study protocol. BMJ Open. 2022 Jan 24;12(1):e052131. doi: 10.1136/bmjopen-2021-052131.
PubMed 35074812Waespe N, Strebel S, Marino D, Mattiello V, Muet F, Nava T, Schindera C, Belle FN, Mader L, Spoerri A, Kuehni CE, Ansari M. Predictors for participation in DNA self-sampling of childhood cancer survivors in Switzerland. BMC Med Res Methodol. 2021 Oct 30;21(1):236. doi: 10.1186/s12874-021-01428-1.
PubMed 34717553
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Risks for Childhood Cancer Complications in Switzerland
- ClinicalTrials.gov ID
- NCT04702321
- Acronym / sponsor ID
- GECCOS / GECCOS
- Conditions
- Childhood Cancer, Genetic Predisposition, Late Effect
- Keywords
- Childhood cancer, Late effects, Therapy complications, Second neoplasm, Registry, Biobank, Genetic variation, Genetic polymorphism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2037 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 8 Jan 2021 (actual)
- 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 objectives of the GECCOS project are to identify genetic variants associated with complications of childhood cancer using genotype-phenotype association studies. Germline genetic samples and data of the "Germline DNA Biobank for Childhood Cancer and Blood Disorders Switzerland" (BISKIDS) which is included in the Geneva Biobank for Hematology and Oncology in Pediatrics (BaHOP) will be used with clinical data of Swiss childhood cancer patients collected at the Institute of Social and Preventive Medicine in Bern.
Detailed description
Background and rationale :
Around 300 children and adolescents are diagnosed with cancer each year in Switzerland. A wide range of acute and chronic complications have been linked to cancer and its treatments. Cancer treatments, though highly curative, have a high incidence of adverse events, not only acutely but also chronically. Depending on the type and dose of treatments, the complications vary. There are important inter-individual differences in the type and severity of complications associated with similar cancer treatments. Genetic variation was identified to affect some complications and is suspected to play an important role in many of these differences.
The GECCOS project on analysis of genetic risks for complications associated with childhood cancers fills the gap to analyze germline genetic data with clinical information on short- and long-term complications. This has not been done on a nationwide scale in Switzerland yet. The GECCOS project will improve knowledge on germline genetic risks for complications and further personalize care during acute treatment and follow-up of childhood cancer patients.
Objectives:
Primary objectives:
- Identify genetic variants associated with complications after childhood cancer leading to specific organ dysfunctions and second primary neoplasms.
- Evaluate the functional importance of genetic variants for complications after childhood cancer through in silico and in vitro studies.
Secondary objective:
Assess genetic variants and their impact on multiple outcomes as a result of specific treatment exposures.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient cohort | – | Other: Procedure: Biospecimen Collection, Other: Procedure: Medical Chart ReviewPatients with clinical data and biospecimens |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Brief description of the anticipated study population: Swiss childhood cancer patients and survivors are being invited to participate in the BaHOP biobank hosting the Germline DNA Biobank for Childhood Cancer and Blood Disorders Switzerland (BISKIDS). Recruitment for BISKIDS is done by the collaborators at the Institute of Social and Preventive Medicine (ISPM), University of Bern. As of December 2019, 9,306 persons were alive and eligible to participate in this project. Participants are invited in batches depending on inclusion criteria of specific sub-projects. Clinical data is collected at the ISPM for childhood cancer patients and survivors since 1976 which will be available for the GECCOS project for genotype-phenotype analysis.
Key inclusion criteria (3 listed)
- Registered in the Swiss Childhood Cancer Registry (SCCR) since 1976; AND
- consented to the BaHOP (host biobank for the BISKIDS Biobanking project); AND
- diagnosed with cancer according to the International Classification of Childhood Cancer, version 3, ICCC-3, or Langerhans cell histiocytosis (LCH) before age 21 years.
Key exclusion criteria (2 listed)
- Lacking written consent signed by participant and/ or their legal representative to participate in the BaHOP (where applicable); OR
- died after study participation and declined use of their samples and data after their death in the original consent for BaHOP (as indicated on the BaHOP 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 |
|---|---|---|
| Procedure: Biospecimen CollectionAlso: Medical Chart ReviewCollection of saliva, buccal swabs, blood, or other sample adequate for germline DNA extraction | Other | Patient cohort |
| Procedure: Medical Chart ReviewAlso: Registry data collectionCollection of clinical data | Other | Patient cohort |
Primary outcome
Genetic variants in participants as a possible marker of risk of complications after childhood cancer
Time frame: Genetic sequencing performed at enrollment into study
Genotyping of germline genetic variants (candidate gene, whole exome, or whole genome sequencing data)
2 secondary outcomes
Number of participants with complications of childhood cancers: specific organ dysfunctions assessed by objective measurements and second primary neoplasms, extracted from medical records and cancer registry information
Time frame: Data collection at enrollment into study, and longitudinal data collection until last follow-up or death from any cause, approx. 10 years
Demographic and clinical covariates corresponding to possible risk factors for specific complications after childhood cancer, extracted from medical records and cancer registry information
Time frame: Data collection at enrollment into study, and longitudinal data collection until last follow-up or death from any cause, approx. 10 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 13 Jan 2021.
- Derived from this study: PubMed 35074812Waespe N, Strebel S, Nava T, Uppugunduri CRS, Marino D, Mattiello V, Otth M, Gumy-Pause F, Von Bueren AO, Baleydier F, Mader L, Spoerri A, Kuehni CE, Ansari M. Cohort-based association study of germline genetic variants with acute and chronic health complications of childhood cancer and its treatment: Genetic Risks for Childhood Cancer Complications Switzerland (GECCOS) study protocol. BMJ Open. 2022 Jan 24;12(1):e052131. doi: 10.1136/bmjopen-2021-052131.
- Derived from this study: PubMed 34717553Waespe N, Strebel S, Marino D, Mattiello V, Muet F, Nava T, Schindera C, Belle FN, Mader L, Spoerri A, Kuehni CE, Ansari M. Predictors for participation in DNA self-sampling of childhood cancer survivors in Switzerland. BMC Med Res Methodol. 2021 Oct 30;21(1):236. doi: 10.1186/s12874-021-01428-1.
- Individual participant dataSharing planned: Yes. Upon specific request to study PI (Marc.Ansari@hcuge.ch or: biskids@cansearch.ch)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancer and Genetic Predisposition, run by University Hospital, Geneva at 1 site in Switzerland.
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 2 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 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 Marc Ansari, Prof (+41 79 553 61 00, Marc.Ansari@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic variants in participants as a possible marker of risk of complications after childhood cancer (time frame: Genetic sequencing performed at enrollment into study). 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 NCT04702321, which also lists 2 linked publications.
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 13 Jan 2021.