Genetic Risks for Childhood Cancer Complications in Switzerland

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04702321

Studienbeginn:
Dezember 2020

Letztes Update:
13.01.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Genetic Predisposition to Disease

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
University Hospital, Geneva

Collaborator:
-

Kontakt

Marc Ansari, Prof
Kontakt:
Phone: +41 79 553 61 00
E-Mail: Marc.Ansari@hcuge.ch» Kontaktdaten anzeigen

Nicolas Waespe, MD
Kontakt:
Phone: +41 77 435 37 95
E-Mail: biskids@cansearch.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital of Geneva
1211 Geneva
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Marc Ansari, Prof
Phone: +41 79 553 61 00
E-Mail: Marc.Ansari@hcuge.ch

Nicolas Waespe, MD
Phone: +41 77 435 37 95
E-Mail: biskids@cansearch.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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).

Studien-Rationale

Primary outcome:

1. 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)

Secondary outcome:

1. 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

2. 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.

Geprüfte Regime

Procedure: Biospecimen Collection (Medical Chart Review):
Collection of saliva, buccal swabs, blood, or other sample adequate for germline DNA extraction
Procedure: Medical Chart Review (Registry data collection):
Collection of clinical data

Quelle: ClinicalTrials.gov

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