Recruitment

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