Childhood Cancer Clinical Trial
— GECCOSOfficial title:
Genetic Risks for Childhood Cancer Complications in Switzerland
NCT number | NCT04702321 |
Other study ID # | GECCOS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2020 |
Est. completion date | December 31, 2037 |
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.
Status | Recruiting |
Enrollment | 6000 |
Est. completion date | December 31, 2037 |
Est. primary completion date | December 31, 2037 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 21 Years |
Eligibility | Inclusion Criteria: 1. Registered in the Swiss Childhood Cancer Registry (SCCR) since 1976; AND 2. consented to the BaHOP (host biobank for the BISKIDS Biobanking project); AND 3. diagnosed with cancer according to the International Classification of Childhood Cancer, version 3, ICCC-3, or Langerhans cell histiocytosis (LCH) before age 21 years. Exclusion Criteria: 1. Lacking written consent signed by participant and/ or their legal representative to participate in the BaHOP (where applicable); OR 2. 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). |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Geneva | Geneva |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Genetic sequencing performed at enrollment into study | |
Secondary | 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 |
Data collection at enrollment into study, and longitudinal data collection until last follow-up or death from any cause, approx. 10 years | |
Secondary | 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. |
Data collection at enrollment into study, and longitudinal data collection until last follow-up or death from any cause, approx. 10 years |
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