Actively Recruiting

Phase Not Applicable
Age: 0 - 21Years
All Genders
ID07378423

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

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-01

205

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

I

Insel Gruppe AG, University Hospital Bern

Lead Sponsor

B

Berner Stiftung für krebskranke Kinder und Jugendliche

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying a questionnaire called QUOCCAS, completed by patients or caregivers, to see if it can accurately identify children and adolescents with cancer who might have an inherited cancer predisposition syndrome (CPS). The study also looks at whether giving families an educational brochure before their clinic visit improves their understanding of genetics and their satisfaction with care. The research compares QUOCCAS results to physician assessments and genetic testing. Participants are randomly assigned to receive either the educational Pre-Visit Preparation (PVP) brochure before completing the QUOCCAS questionnaire or to complete the questionnaire without the brochure. All participants provide a saliva or blood sample for genetic testing through whole-exome or whole-genome sequencing. The study also uses a clinician tool called MIPOGG to assess genetic risk, and results from all methods are compared. During the study, participants complete the QUOCCAS questionnaire and provide samples for genetic sequencing. They also fill out surveys about their knowledge of genetics and satisfaction with care. The main measure is how well QUOCCAS identifies CPS compared to genetic testing, with additional evaluations of caregiver knowledge and satisfaction. The study lasts up to 36 months and monitors the feasibility of using these tools in clinical care.

CONDITIONS

Brief Title

Questionnaire on Congenital Cancer Signs Through Self-Assessment

Who Can Participate

Age: 0 - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed patients with a cancer diagnosis included in the International Classification of Childhood Cancer version 3 (ICCC3) criteria
  • Treated at participating hospitals
  • 21 years of age or younger
Not Eligible

You will not qualify if you...

  • Over 21 years of age

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 36 months

Participants complete the QUOCCAS questionnaire and provide a saliva or blood sample for germline genetic sequencing to identify signs suggestive of cancer predisposition syndromes. Some participants receive a Pre-Visit Preparation brochure before completing the questionnaire to improve knowledge and engagement. Additionally, medical records are reviewed using the MIPOGG digital decision-support tool.

1 to 2 visits depending on group assignment

Long-term Monitoring

Duration - Up to 36 months

Participants complete follow-up surveys to assess genetic literacy, satisfaction with care, and feasibility of the questionnaire and brochure implementation over time.

Periodic follow-up contacts

Trial Site Locations

Total: 1 location

1

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

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

N

Nicolas Waespe, MD PhD, PD

J

Jakica Cavar, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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