Self‑report questionnaire to spot inherited cancer risk in children and teens
Questionnaire on Congenital Cancer Signs Through Self-Assessment (QUOCCAS)
This project will test whether a caregiver- or patient-completed questionnaire plus a short pre-visit brochure can help identify children and adolescents with an inherited cancer predisposition and improve caregiver genetics knowledge and satisfaction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 205 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT07378423 on ClinicalTrials.gov |
What this trial studies
Newly diagnosed children and adolescents treated at the University Children’s Hospital Bern will complete the QUOCCAS questionnaire about family history and cancer signs and provide a blood or saliva sample for germline sequencing (whole-exome or whole-genome). Families will be randomly assigned to receive a Pre-Visit Preparation (PVP) brochure or not before their clinic visit to measure effects on caregiver genetics knowledge and satisfaction. The QUOCCAS results will be compared with physician-based tools (including MIPOGG) and with germline genetic testing to determine how well the questionnaire flags potential cancer predisposition syndromes. Study outcomes include the questionnaire’s accuracy against sequencing and changes in caregiver understanding and satisfaction.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents under age 21 with a newly diagnosed cancer included in ICCC3 who are treated at the participating University Children’s Hospital Bern.
Not a fit: Patients older than 21, those whose diagnosis is not covered by ICCC3, or those already known to have a genetic cancer predisposition are unlikely to benefit from this enrollment.
Why it matters
Potential benefit: If successful, this approach could help identify children with inherited cancer risk earlier, enabling targeted surveillance, tailored care, and cascade testing for family members.
How similar studies have performed: Clinician checklists and family-history tools have shown promise in identifying some cancer predisposition syndromes, but direct comparisons with comprehensive germline sequencing and the addition of pre-visit education remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The investigators will include newly diagnosed patients who received a cancer diagnosis included in the International Classification of Childhood Cancer version 3 (ICCC3) criteria, treated at participating hospitals Exclusion Criteria: * Over 21 years of age
Where this trial is running
Bern
- Inselspital, Universitäts Kinderklinik (University Children's Hospital) Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Nicolas Waespe, MD PhD, PD — University Children's Hospital Bern, Inselspital, Bern, Switzerland
- Study coordinator: Nicolas Waespe, MD PhD, PD
- Email: quoccas@insel.ch
- Phone: +41 77 435 37 95
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.