Genetic Risks for Childhood Cancer Complications in Switzerland
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 21
SponsorUniversity Hospital, Geneva
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Procedure: Biospecimen Collection
Other interventionCollection of saliva, buccal swabs, blood, or other sample adequate for germline DNA extraction
Procedure: Medical Chart Review
Other interventionCollection of clinical data
Treatment groups
6,000 Participants
are divided into 1 treatment groupGroup A: Patient cohort2 interventions
Trial outcomes
Primary outcomes
1
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)
Time frame
Genetic sequencing performed at enrollment into studySecondary outcomes
1
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
Time frame
Data collection at enrollment into study, and longitudinal data collection until last follow-up or death from any cause, approx. 10 years2
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.
Time frame
Data collection at enrollment into study, and longitudinal data collection until last follow-up or death from any cause, approx. 10 yearsSponsors and contacts
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Source ClinicalTrials.gov