Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27,500
- 试验地点
- 2
- 主要终点
- Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ALL COHORTS: 18 years of age or older
- •Retrospective COHORT A: Per HIPAA waiver, Retrospective Cohort A will not actively consent
- •Retrospective COHORT A: Patients may or may not be diagnosed with cancer
- •Retrospective COHORT A: Patients have received genetic counseling in the past 5 years
- •Retrospective COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome
- •COHORT A: Per Health Insurance Portability and Accountability Act (HIPAA) waiver, Cohort A returns survey as consent
- •COHORT A: Patients may or may not be diagnosed with cancer
- •COHORT A: Patients have received genetic counseling in the past 1 - 2 years
- •COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome
- •COHORT A: INCLUSIVE of no contact list to exclude from Cohort B
- •COHORT B: Creation of secure Healthy Oregon Project (HOP) app account
- •COHORT B: Consent to this project, either hard or electronic signature
- •COHORT B: Consent to the HOP repository, either hard or electronic signature
- •COHORT B: Choosing to submit a deoxyribonucleic acid (DNA) sample
- •COHORT B: Patients diagnosed with any National Cancer Institute (NCI)-reportable cancers, including ductal carcinoma in situ (DCIS) and/or in situ breast cancer
- •COHORT B: Must have had an encounter within past twelve months
- •COHORT B: Exclude Cohort A
- •COHORT C: Creation of secure Hop app account
- •COHORT C: Consent to this project, either hard or electronic signature
- •COHORT C: Consent to the HOP repository, either hard or electronic signature
- •COHORT C: Choosing to submit a DNA sample
排除标准
- 未提供
研究组 & 干预措施
Screening (genetic testing)
Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
干预措施: Survey Administration (Other)
Screening (genetic testing)
Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
干预措施: Biospecimen Collection (Procedure)
Screening (genetic testing)
Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
干预措施: Genetic Counseling (Other)
Screening (genetic testing)
Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
干预措施: Genetic Testing (Other)
结局指标
主要结局
Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations
时间窗: Up to 5 years
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.
Cascade screening rate among Lynch or HBOC positive carriers
时间窗: Up to 5 years
Will conduct negative binomial regression model and non-inferiority will be determined by rate ratio and its 95% confidence interval (CI).
Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes
时间窗: Up to 5 years
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.
Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging
时间窗: Up to 5 years
The merged risk reduction strategies of BSO or bilateral mastectomy and the imaging are treated as evidence of risk reducing behavior.
次要结局
未报告次要终点
研究者
Jackie Shannon
Principal Investigator
OHSU Knight Cancer Institute