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NCT Number: NCT07378423

Questionnaire on Congenital Cancer Signs Through Self-Assessment

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

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Key information

Conditions

Cancer Predisposition Syndromes Childhood Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Cancer Syndromes Neoplasms Neoplastic Syndromes, Hereditary Pediatric Cancer

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inselspital, Universitäts Kinderklinik (University Children's Hospital) Bern

Bern, 3010, Switzerland

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-Visit Preparation (PVP) Brochure

Behavioral

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.

Other names: Educational Brochure

QUOCCAS Questionnaire

Diagnostic Test

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).

Other names: Questionnaire on Congenital Cancer Signs through Self-Assessment

Germline genetic sequencing for Cancer Predisposition Syndromes (CPS)

Diagnostic Test

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).

MIPOGG Assessment

Diagnostic Test

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.

Primary outcomes

  1. Sensitivity and Specificity of the QUOCCAS Questionnaire for Identifying Cancer Predisposition Syndromes (CPS)

    Time frame: Baseline to study completion, up to 36 months

    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.

Secondary outcomes

  1. Genetic Literacy Score of Caregivers

    Time frame: Baseline to study completion, up to 36 months

    Change in caregiver knowledge and understanding of genetics and cancer predisposition syndromes, measured with a validated genetic literacy questionnaire (Fitzgerald-Butt et al. 2016) and additional CPS-specific items. The genetic literacy score comprises 18 items with each correct item being attributed one point (higher scores from 0-18 indicating higher genetic literacy). The CPS-specific part comprises 10 items with each correctly answered item being attributed one point (higher scores from 0-10 indicating higher genetic literacy). Mean scores of each item will be compared between participants who received the Pre-Visit Preparation (PVP) brochure and those who did not.

  2. Patient and Caregiver Satisfaction with Care and Information

    Time frame: Baseline to study completion, up to 36 months

    Satisfaction measured using the Picker Patient Experience Questionnaire (PPE-15), adapted for the study, focusing on clarity of information, involvement in decision-making, and overall satisfaction with care. Proportions of problematic items (with higher proportions indicating more problematic encounters and negative experience) will be compared between families receiving the PVP brochure and those not receiving it.

  3. Feasibility of Implementing QUOCCAS Questionnaire for Identifying Cancer Predisposition Syndromes and the Pre-Visit Preparation (PVP) Brochure

    Time frame: At study completion, up to 36 months

    Feasibility will be evaluated through the proportion of eligible families who successfully complete the QUOCCAS questionnaire, average time to complete the questionnaire, and provider survey feedback on ease of use and workflow integration.

Study contacts

Contact information is provided by the study sponsor or research team.

Jakica Cavar, MSc

CONTACT

Nicolas Waespe, MD PhD, PD

CONTACT

[email protected]

+41 77 435 37 95

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Berner Stiftung für krebskranke Kinder und Jugendliche
  • Childhood Cancer Switzerland
  • Fondation CANSEARCH
  • Swiss Cancer League
  • Zoé4Life

Registry information

Official study title

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

Acronym: QUOCCAS

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 30, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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