Questionnaire on Congenital Cancer Signs Through Self-Assessment
QUOCCAS
1 other identifier
interventional
205
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2025
CompletedFirst Posted
Study publicly available on registry
January 30, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
May 1, 2026
April 1, 2026
2.8 years
November 18, 2025
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of the QUOCCAS Questionnaire for Identifying Cancer Predisposition Syndromes (CPS)
Accuracy of the QUOCCAS questionnaire in identifying childhood cancer patients at increased risk for a cancer predisposition syndrome, compared to (1) physician standard of care referral, (2) the McGill Interactive Paediatric Oncogenetic Guidelines (MIPOGG), and (3) the gold standard of germline genetic sequencing. Sensitivity is defined as the proportion of CPS cases correctly identified by QUOCCAS; specificity is the proportion of non-CPS cases correctly identified.
Baseline to study completion, up to 36 months
Secondary Outcomes (3)
Genetic Literacy Score of Caregivers
Baseline to study completion, up to 36 months
Patient and Caregiver Satisfaction with Care and Information
Baseline to study completion, up to 36 months
Feasibility of Implementing QUOCCAS Questionnaire for Identifying Cancer Predisposition Syndromes and the Pre-Visit Preparation (PVP) Brochure
At study completion, up to 36 months
Study Arms (2)
Pre-Visit Preparation (PVP) Brochure + QUOCCAS Questionnaire
EXPERIMENTALParticipants will receive the educational Pre-Visit Preparation (PVP) brochure before completing the QUOCCAS questionnaire. They will also provide a saliva or blood sample for germline genetic sequencing and complete follow-up surveys.
QUOCCAS Questionnaire Only
ACTIVE COMPARATORParticipants will complete the QUOCCAS questionnaire without receiving the Pre-Visit Preparation (PVP) brochure. They will also provide a saliva or blood sample for germline genetic sequencing and complete follow-up surveys.
Interventions
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.
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).
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Over 21 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Insel Gruppe AG, University Hospital Bernlead
- Berner Stiftung für krebskranke Kinder und Jugendlichecollaborator
- Zoé4Lifecollaborator
- Swiss Cancer Leaguecollaborator
- Fondation CANSEARCHcollaborator
- Childhood Cancer Switzerlandcollaborator
Study Sites (1)
Inselspital, Universitäts Kinderklinik (University Children's Hospital) Bern
Bern, 3010, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas Waespe, MD PhD, PD
University Children's Hospital Bern, Inselspital, Bern, Switzerland
Central Study Contacts
Jakica Cavar, MSc
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2025
First Posted
January 30, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2029
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Sensitive data on genetic disease of a small patient group which might lead to confidentiality issues. On request, anonymised data can be requested after study completion from the principal investigator.