Genetic Risks for Childhood Cancer Complications in Switzerland

NCT04702321 | Recruiting

• 1 other identifier: GECCOS
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Cancer; Genetic Predisposition; Late Effect

Keywords

Childhood cancer; Late effects; Therapy complications; Second neoplasm; Registry; Biobank; Genetic variation; Genetic polymorphism; Pharmacogenetics; Genetic association studies

Outcome Measures

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)

  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

  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

  Data collection at enrollment into study, and longitudinal data collection until last follow-up or death from any cause, approx. 10 years

Study Arms (1)

Patient cohort

Patients with clinical data and biospecimens

Other: Procedure: Biospecimen Collection; Other: Procedure: Medical Chart Review

Interventions

Procedure: Biospecimen Collection OTHER

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

Also known as: Medical Chart Review

Patient cohort

Procedure: Medical Chart Review OTHER

Collection of clinical data

Also known as: Registry data collection

Patient cohort

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospital of Geneva

Geneva, 1211, Switzerland

RECRUITING

Related Publications (2)

• 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.

  PMID: 35074812 DERIVED

• Waespe 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.

  PMID: 34717553 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Description: saliva, buccal swabs, blood, or other sample adequate for germline DNA extraction.

MeSH Terms

Conditions

Neoplasms; Genetic Predisposition to Disease; Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marc Ansari, Prof

CONTACT

+41 79 553 61 00; Marc.Ansari@hcuge.ch

Nicolas Waespe, MD

CONTACT

+41 77 435 37 95; biskids@cansearch.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Marc Ansari

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: January 8, 2021
• Study Start: December 1, 2020
• Primary Completion (Estimated): December 31, 2037
• Study Completion (Estimated): December 31, 2037
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)