Genetic Risks for Childhood Cancer Complications in Switzerland (GECCOS)

January 11, 2021 updated by: Marc Ansari, University Hospital, Geneva
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  1. Identify genetic variants associated with complications after childhood cancer leading to specific organ dysfunctions and second primary neoplasms.
  2. 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 Type

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Genetic sequencing performed at enrollment into study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
  • 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
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Anticipated)

December 31, 2037

Study Completion (Anticipated)

December 31, 2037

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GECCOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon specific request to study PI (Marc.Ansari@hcuge.ch or: biskids@cansearch.ch)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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