NCT07378423

Questionnaire on Congenital Cancer Signs Through Self-Assessment

Questionnaire on Congenital Cancer Signs Through Self-Assessment (QUOCCAS)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial tests whether a patient- and caregiver-completed questionnaire (QUOCCAS) can accurately help identify children and adolescents with cancer who may have an underlying cancer predisposition syndrome (CPS). The study will also evaluate whether providing families with an educational brochure before their clinic visit improves their understanding of genetics and their satisfaction with care. The main questions it aims to answer are: * Does QUOCCAS identify children at risk for CPS as accurately as physician-based tools and compared to genetic testing? * Does the Pre-Visit Preparation (PVP) brochure improve caregiver knowledge about genetics? * Does the PVP brochure improve caregiver satisfaction with the care and information they receive? Participants will: * Complete the QUOCCAS questionnaire about family history, clinical features, and cancer signs * Provide a blood or saliva sample for genetic testing (whole-exome or whole-genome sequencing) * Randomly receive or not receive the educational Pre-Visit Preparation brochure before completing the questionnaire * Complete brief surveys on their knowledge and satisfaction

Conditions

• Cancer Predisposition Syndromes
• Pediatric Cancer
• Childhood Neoplasms
• Hereditary Cancer Syndromes

Interventions

Type	Name	Description
BEHAVIORAL	Pre-Visit Preparation (PVP) Brochure	Participants receive a Pre-Visit Preparation (PVP) brochure containing information about cancer predisposition syndromes, genetic testing, and implications for care. The brochure is provided before completion of the QUOCCAS questionnaire and is designed to improve caregiver knowledge, engagement, and satisfaction with care.
DIAGNOSTIC_TEST	QUOCCAS Questionnaire	Participants complete the QUOCCAS questionnaire, a structured, self- or caregiver-reported tool designed to identify clinical features, family history, and signs suggestive of cancer predisposition syndromes. Responses are used to classify risk status and are compared against physician-based tools and genetic testing (germline genetic sequencing).
DIAGNOSTIC_TEST	Germline genetic sequencing for Cancer Predisposition Syndromes (CPS)	All participants will provide a saliva or blood sample for germline genetic sequencing. The investigators will perform either whole-exome (WES) or whole-genome sequencing (WGS) and assess for pathogenic/ likely-pathogenic variants in known Cancer Predisposition Genes (CPS).
DIAGNOSTIC_TEST	MIPOGG Assessment	The McGill Interactive Pediatric OncoGenetic Guidelines (MIPOGG) is a clinician-applied digital decision-support tool that uses patient age, tumor type, and clinical features to generate recommendations for referral to genetics. In this study, all participants will undergo MIPOGG assessment performed by the research team through the use of medical records. Results will be compared with those from the QUOCCAS questionnaire to evaluate concordance and potential equivalence in identifying children with cancer predisposition syndromes.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

1 site across 1 country: Switzerland