Identifying and Caring for Individuals With Inherited Cancer Syndrome
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- STATUS
- Recruiting
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- End date
- Jun 10, 2030
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- participants needed
- 27500
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- sponsor
- OHSU Knight Cancer Institute
Summary
This trial examines approaches to identify and care for individuals with inherited cancer syndrome. The purpose of this study is to offer no cost genetic testing to the general public. Researchers hope to learn the value of providing broad, public-wide testing for high risk cancer types (like hereditary breast and ovarian cancer or Lynch syndromes) instead of only testing people whose families are known to be high risk.
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 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.
Details
| Condition | BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphoid System Neoplasm, Hereditary Neoplastic Syndrome, Lynch Syndrome, Malignant Solid Neoplasm |
|---|---|
| Treatment | genetic testing, Genetic Counseling, survey administration, biospecimen collection |
| Clinical Study Identifier | NCT04494945 |
| Sponsor | OHSU Knight Cancer Institute |
| Last Modified on | 23 March 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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