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

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Childhood Neoplasms; Cancer Predisposition Syndromes; Hereditary Cancer Syndromes; Pediatric Cancer

Treatments: Diagnostic Test: Germline genetic sequencing for Cancer Predisposition Syndromes (CPS); Behavioral: Pre-Visit Preparation (PVP) Brochure; Diagnostic Test: QUOCCAS Questionnaire; Diagnostic Test: MIPOGG Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT07378423

2025-01346

Details and patient eligibility

About

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

Enrollment: 205 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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205 participants in 2 patient groups

Pre-Visit Preparation (PVP) Brochure + QUOCCAS Questionnaire

Experimental group

Description:

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.

Treatment:

Diagnostic Test: MIPOGG Assessment

Diagnostic Test: QUOCCAS Questionnaire

Diagnostic Test: Germline genetic sequencing for Cancer Predisposition Syndromes (CPS)

Behavioral: Pre-Visit Preparation (PVP) Brochure

QUOCCAS Questionnaire Only

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: MIPOGG Assessment

Diagnostic Test: QUOCCAS Questionnaire

Diagnostic Test: Germline genetic sequencing for Cancer Predisposition Syndromes (CPS)