Questionnaire on Congenital Cancer Signs Through Self-Assessment (QUOCCAS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity of the QUOCCAS Questionnaire for Identifying Cancer Predisposition Syndromes (CPS)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Over 21 years of age
研究组 & 干预措施
Pre-Visit Preparation (PVP) Brochure + QUOCCAS Questionnaire
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.
干预措施: Pre-Visit Preparation (PVP) Brochure (Behavioral)
Pre-Visit Preparation (PVP) Brochure + QUOCCAS Questionnaire
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.
干预措施: QUOCCAS Questionnaire (Diagnostic Test)
Pre-Visit Preparation (PVP) Brochure + QUOCCAS Questionnaire
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.
干预措施: Germline genetic sequencing for Cancer Predisposition Syndromes (CPS) (Diagnostic Test)
Pre-Visit Preparation (PVP) Brochure + QUOCCAS Questionnaire
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.
干预措施: MIPOGG Assessment (Diagnostic Test)
QUOCCAS Questionnaire Only
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.
干预措施: QUOCCAS Questionnaire (Diagnostic Test)
QUOCCAS Questionnaire Only
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.
干预措施: Germline genetic sequencing for Cancer Predisposition Syndromes (CPS) (Diagnostic Test)
QUOCCAS Questionnaire Only
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.
干预措施: MIPOGG Assessment (Diagnostic Test)
结局指标
主要结局
Sensitivity and Specificity of the QUOCCAS Questionnaire for Identifying Cancer Predisposition Syndromes (CPS)
时间窗: 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.
次要结局
- Genetic Literacy Score of Caregivers(Baseline to study completion, up to 36 months)
- 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)