Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-04627 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00020629 | Other Identifier | OHSU Knight Cancer Institute | |
| U01CA232819 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Oregon Health and Science University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening (genetic testing) | Other | Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of saliva sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations | 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. | Up to 5 years |
| Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes | For Lynch syndrome we identify compliance as colonoscopy in past two years and bilateral salpingo-oophorectomy (BSO ) after child-bearing age. For HBOC, compliance is defined as breast imaging in past year or risk reducing surgery at any point in women. | Up to 5 years |
| Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging | The merged risk reduction strategies of BSO or bilateral mastectomy and the imaging are treated as evidence of risk reducing behavior. | Up to 5 years |
| Cascade screening rate among Lynch or HBOC positive carriers | Will conduct negative binomial regression model and non-inferiority will be determined by rate ratio and its 95% confidence interval (CI). | Up to 5 years |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jackilen Shannon, Ph.D. | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Portland Medical Center | Recruiting | Portland | Oregon | 97213 | United States |
Data and samples collected under this protocol will be stored indefinitely in this study's repository for future research use. Participants must agree to future research use of their samples/data to participate in HOP.
Data/samples from participants who identify as American Indian/Alaska Native will be flagged within the HOP database so they can be excluded from data/sample releases for research purposes.
HOP has created a Data Access Committee (DAC) to review all requests for HOP data/samples. The DAC will review requests for feasibility and scientific merit before any data/samples are released.
OHSU investigators wishing to receive data from this study will sign a data release agreement documenting they will:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Genetic Counseling | Other | Receive genetic counseling if testing results are positive |
|
| Genetic Testing | Other | Undergo genetic testing |
|
|
| Survey Administration | Other | Complete a survey |
|
| OHSU Knight Cancer Institute | Recruiting | Portland | Oregon | 97239 | United States |
|
| ID | Term |
|---|---|
| D061325 | Hereditary Breast and Ovarian Cancer Syndrome |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D009386 | Neoplastic Syndromes, Hereditary |
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005817 | Genetic Counseling |
| D005820 | Genetic Testing |
| ID | Term |
|---|---|
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
Not provided
Not provided