Genetic Risks for Childhood Cancer Complications in Switzerland

NCT ID: NCT04702321

Last Updated: 2021-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2037-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Childhood Cancer Genetic Predisposition Late Effect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patient cohort

Patients with clinical data and biospecimens

Procedure: Biospecimen Collection

Intervention Type OTHER

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

Procedure: Medical Chart Review

Intervention Type OTHER

Collection of clinical data

Interventions

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Procedure: Biospecimen Collection

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

Intervention Type OTHER

Procedure: Medical Chart Review

Collection of clinical data

Intervention Type OTHER

Other Intervention Names

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Medical Chart Review Registry data collection

Eligibility Criteria

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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).
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Marc Ansari

Professor Marc Ansari

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Geneva

Geneva, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Marc Ansari, Prof

Role: CONTACT

+41 79 553 61 00

Nicolas Waespe, MD

Role: CONTACT

+41 77 435 37 95

Facility Contacts

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Marc Ansari, Prof

Role: primary

+41 79 553 61 00

Nicolas Waespe, MD

Role: backup

+41 77 435 37 95

References

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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.

Reference Type DERIVED
PMID: 35074812 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34717553 (View on PubMed)

Other Identifiers

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GECCOS

Identifier Type: -

Identifier Source: org_study_id

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