NCT07378423|RecruitingDMC
Questionnaire on Congenital Cancer Signs Through Self-Assessment
QUOCCAS
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QUOCCAS
Sponsor study identifier
Secondary identifiers
NIH
interventional
205
1 country
1
Study Start
April 1, 2026
Actual (reported)Primary Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 18, 2025
Actual (reported)January 30, 2026
Actual (reported)April 1, 2026
Actual (reported)December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Genetic Literacy Score of Caregivers
Baseline to study completion, up to 36 months
Participants 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.
Participants 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.
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.
Inselspital, Universitäts Kinderklinik (University Children's Hospital) Bern
Bern, 3010, Switzerland
Nicolas Waespe, MD PhD, PD
University Children's Hospital Bern, Inselspital, Bern, Switzerland
Jakica Cavar, MSc
CONTACT
First Submitted
November 18, 2025
First Posted
January 30, 2026
Study Start
April 1, 2026
Actual (reported)Primary Completion
December 31, 2028
EstimatedNurse-led Transitional Care to Improve Symptom Management in Childhood Cancer Survivors
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 1, 2026
Record last verified: 2026-04
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.
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Source: ClinicalTrials.gov.
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