Identifying and Caring for Individuals With Inherited Cancer Syndrome
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Ductal Carcinoma In Situ
- Hematopoietic and Lymphoid System Neoplasm
- Hereditary Neoplastic Syndrome
- Lynch Syndrome
- Malignant Solid Neoplasm
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Screening
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. Evaluate the effectiveness and sustainability of heritable cancer syndrome testing in two proposed screening populations compared to current guidelines. SECONDARY OBJECTIVES: I. Measure adherence to current guidelines for screening and prophylactic intervention of Cohorts B and...
PRIMARY OBJECTIVE: I. Evaluate the effectiveness and sustainability of heritable cancer syndrome testing in two proposed screening populations compared to current guidelines. SECONDARY OBJECTIVES: I. Measure adherence to current guidelines for screening and prophylactic intervention of Cohorts B and C compared to Cohort A to show non-inferiority. II. Measure the efficiency of cascade testing (defined as the ratio of family members screened over total possible) for Cohorts B and C compared to Cohort A to show non-inferiority. III. Determine the costs and effectiveness, specifically quality adjusted life years (QALYs) associated with genetic screening models based on Cohorts B and C to estimate incremental cost-effectiveness ratio (ICER) and show that the costs per QALY are below the acceptable cost effectiveness threshold. OUTLINE: Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling. Patients also complete a survey about cancer prevention, screening, and treatment.
Tracking Information
- NCT #
- NCT04494945
- Collaborators
- National Cancer Institute (NCI)
- Oregon Health and Science University
- Investigators
- Principal Investigator: Paul T Spellman, Ph.D. OHSU Knight Cancer Institute