Cancer Predisposition SyndromesQUOCCASNCT07378423
Questionnaire on Congenital Cancer Signs Through Self-Assessment
A study testing Pre-Visit Preparation (PVP) Brochure, QUOCCAS Questionnaire and Germline genetic sequencing for Cancer Predisposition Syndromes (CPS) in people with Cancer Predisposition Syndromes and Pediatric Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Cancer Predisposition Syndromes, Pediatric Cancer, Childhood Neoplasms
- What is being tested?
- Pre-Visit Preparation (PVP) Brochure, QUOCCAS Questionnaire and Germline genetic sequencing for Cancer Predisposition Syndromes (CPS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Over 21 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jakica Cavar, MSc contact
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital, Universitäts Kinderklinik (University Children's Hospital) Bern
Bern, 3010
About this study
Official title: Questionnaire on Congenital Cancer Signs Through Self-Assessment (QUOCCAS)
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:
Read more
- 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
- Conditions
- Cancer Predisposition Syndromes, Pediatric Cancer, Childhood Neoplasms, Hereditary Cancer Syndromes
- Being tested
- Pre-Visit Preparation (PVP) Brochure, QUOCCAS Questionnaire, Germline genetic sequencing for Cancer Predisposition Syndromes (CPS), MIPOGG Assessment
- Keywords
- Cancer Predisposition Syndrome (CPS), Pediatric Oncology, Childhood Cancer, Genetic Testing, Whole-Exome Sequencing (WES), Screening Tool, Patient-Reported Outcomes, Genetic Literacy, Whole-Genome Sequencing (WGS)
- Medical subject headings
- Neoplasms, Neoplastic Syndromes, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Visit Preparation (PVP) BrochureBehavioural
Also called Educational Brochure
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.
QUOCCAS QuestionnaireDiagnostic test
Also called Questionnaire on Congenital Cancer Signs through Self-Assessment
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).
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 AssessmentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Visit Preparation (PVP) Brochure + QUOCCAS Questionnaire | Experimental | 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. Receives: Behavioral: Pre-Visit Preparation (PVP) Brochure; Diagnostic Test: QUOCCAS Questionnaire; Diagnostic Test: Germline genetic sequencing for Cancer Predisposition Syndromes (CPS); Diagnostic Test: MIPOGG Assessment |
| QUOCCAS Questionnaire Only | Active comparator | 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. Receives: Diagnostic Test: QUOCCAS Questionnaire; Diagnostic Test: Germline genetic sequencing for Cancer Predisposition Syndromes (CPS); Diagnostic Test: MIPOGG Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to study completion, up to 36 months
Secondary outcomes (3)
Genetic Literacy Score of Caregivers
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.
Measured: Baseline to study completion, up to 36 months
Patient and Caregiver Satisfaction with Care and Information
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.
Measured: 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
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.
Measured: At study completion, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Predisposition SyndromesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Berner Stiftung für krebskranke Kinder und Jugendliche, Fondation CANSEARCH, Childhood Cancer Switzerland, Zoé4Life, Swiss Cancer League
- Responsible party
- Sponsor
- Investigators
- Nicolas Waespe, MD PhD, PD, Principal investigator, University Children's Hospital Bern, Inselspital, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378423
- Sponsor's protocol ID
- 2025-01346
- Other IDs
- 2025
- Acronym
- QUOCCAS
- Status last verified
- Apr 2026
- First submitted
- 18 Nov 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Questionnaire on Congenital Cancer Signs Through Self-Assessment (QUOCCAS)
- ClinicalTrials.gov ID
- NCT07378423
- Acronym / sponsor ID
- QUOCCAS / 2025-01346
- Conditions
- Cancer Predisposition Syndromes, Pediatric Cancer, Childhood Neoplasms, Hereditary Cancer Syndromes
- Keywords
- Cancer Predisposition Syndrome (CPS), Pediatric Oncology, Childhood Cancer, Genetic Testing, Whole-Exome Sequencing (WES), Screening Tool, Patient-Reported Outcomes, Genetic Literacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Berner Stiftung für krebskranke Kinder und Jugendliche, Fondation CANSEARCH, Childhood Cancer Switzerland, Zoé4Life, Swiss Cancer League
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Visit Preparation (PVP) Brochure + QUOCCAS Questionnaire | Experimental | Behavioral: Pre-Visit Preparation (PVP) Brochure, Diagnostic Test: QUOCCAS Questionnaire, Diagnostic Test: Germline genetic sequencing for Cancer Predisposition Syndromes (CPS), Diagnostic Test: MIPOGG AssessmentParticipants 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 comparator | Diagnostic Test: QUOCCAS Questionnaire, Diagnostic Test: Germline genetic sequencing for Cancer Predisposition Syndromes (CPS), Diagnostic Test: MIPOGG AssessmentParticipants 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. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Over 21 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-Visit Preparation (PVP) BrochureAlso: Educational BrochureParticipants 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. | Behavioural | Pre-Visit Preparation (PVP) Brochure + QUOCCAS Questionnaire |
| QUOCCAS QuestionnaireAlso: Questionnaire on Congenital Cancer Signs through Self-AssessmentParticipants 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). | Diagnostic test | Pre-Visit Preparation (PVP) Brochure + QUOCCAS Questionnaire, QUOCCAS Questionnaire Only |
| Germline genetic sequencing for Cancer Predisposition Syndromes (CPS)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). | Diagnostic test | Pre-Visit Preparation (PVP) Brochure + QUOCCAS Questionnaire, QUOCCAS Questionnaire Only |
| MIPOGG AssessmentThe 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. | Diagnostic test | Pre-Visit Preparation (PVP) Brochure + QUOCCAS Questionnaire, QUOCCAS Questionnaire Only |
Primary outcome
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.
3 secondary outcomes
Genetic Literacy Score of Caregivers
Time frame: Baseline to study completion, up to 36 months
Patient and Caregiver Satisfaction with Care and Information
Time frame: 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
Time frame: At study completion, up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jakica Cavar, MSc contact
Nicolas Waespe, MD PhD, PD principal investigator
University Children's Hospital Bern, Inselspital, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Visit Preparation (PVP) Brochure, QUOCCAS Questionnaire and Germline genetic sequencing for Cancer Predisposition Syndromes (CPS) in people with Cancer Predisposition Syndromes and Pediatric Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Waespe, MD PhD, PD (+41 77 435 37 95, quoccas@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of the QUOCCAS Questionnaire for Identifying Cancer Predisposition Syndromes (CPS) (time frame: Baseline to study completion, up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.