GECCOS: Genetic Risks for Childhood Cancer Complications in Switzerland

Sponsor

University Hospital, Geneva (Other)

Overall Status

Recruiting

CT.gov ID

NCT04702321

Collaborator

(none)

6,000

Enrollment

Location

205

Anticipated Duration (Months)

29.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Cancer Genetic Predisposition Late Effect	Other: Procedure: Biospecimen Collection Other: Procedure: Medical Chart Review

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

Study Type:

Observational

Anticipated Enrollment :

6000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Genetic Risks for Childhood Cancer Complications in Switzerland

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2037

Anticipated Study Completion Date :

Dec 31, 2037

Arms and Interventions

Arm	Intervention/Treatment
Patient cohort Patients with clinical data and biospecimens	Other: Procedure: Biospecimen Collection Collection of saliva, buccal swabs, blood, or other sample adequate for germline DNA extraction Other Names: Medical Chart Review Other: Procedure: Medical Chart Review Collection of clinical data Other Names: Registry data collection

Arm

Intervention/Treatment

Patient cohort

Patients with clinical data and biospecimens

Other: Procedure: Biospecimen Collection

Collection of saliva, buccal swabs, blood, or other sample adequate for germline DNA extraction

Other Names:

Medical Chart Review

Other: Procedure: Medical Chart Review

Collection of clinical data

Other Names:

Registry data collection

Outcome Measures

Primary Outcome Measures

Genetic variants in participants as a possible marker of risk of complications after childhood cancer [Genetic sequencing performed at enrollment into study]
Genotyping of germline genetic variants (candidate gene, whole exome, or whole genome sequencing data)

Secondary Outcome Measures

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 [Data collection at enrollment into study, and longitudinal data collection until last follow-up or death from any cause, approx. 10 years]
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
Demographic and clinical covariates corresponding to possible risk factors for specific complications after childhood cancer, extracted from medical records and cancer registry information [Data collection at enrollment into study, and longitudinal data collection until last follow-up or death from any cause, approx. 10 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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).