Identifying and Caring for Individuals With Inherited Cancer Syndrome
Primary Purpose
BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphoid System Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection
Genetic Counseling
Genetic Testing
Survey Administration
Sponsored by
About this trial
This is an interventional screening trial for BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome
Eligibility Criteria
Inclusion Criteria:
- 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 Medable account
- COHORT B: Consent to this project, either hard or electronic signature
- COHORT B: Consent to the Healthy Oregon Project (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 Medable 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
Sites / Locations
- Providence Portland Medical CenterRecruiting
- OHSU Knight Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Screening (genetic testing)
Arm Description
Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
Outcomes
Primary Outcome Measures
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.
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.
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04494945
First Posted
July 28, 2020
Last Updated
August 10, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI), Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT04494945
Brief Title
Identifying and Caring for Individuals With Inherited Cancer Syndrome
Official Title
Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2020 (Actual)
Primary Completion Date
June 10, 2025 (Anticipated)
Study Completion Date
June 10, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI), Oregon Health and Science University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Screening (genetic testing)
Arm Type
Other
Arm Description
Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection
Intervention Description
Undergo collection of saliva sample
Intervention Type
Other
Intervention Name(s)
Genetic Counseling
Intervention Description
Receive genetic counseling if testing results are positive
Intervention Type
Other
Intervention Name(s)
Genetic Testing
Other Intervention Name(s)
genetic analysis, Genetic Examination, Genetic Test
Intervention Description
Undergo genetic testing
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Complete a survey
Primary Outcome Measure Information:
Title
Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations
Description
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.
Time Frame
Up to 5 years
Title
Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes
Description
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.
Time Frame
Up to 5 years
Title
Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging
Description
The merged risk reduction strategies of BSO or bilateral mastectomy and the imaging are treated as evidence of risk reducing behavior.
Time Frame
Up to 5 years
Title
Cascade screening rate among Lynch or HBOC positive carriers
Description
Will conduct negative binomial regression model and non-inferiority will be determined by rate ratio and its 95% confidence interval (CI).
Time Frame
Up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Medable account
COHORT B: Consent to this project, either hard or electronic signature
COHORT B: Consent to the Healthy Oregon Project (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 Medable 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jackilen Shannon, Ph.D.
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bill J. Wright, Ph.D.
Email
Bill.Wright@providence.org
First Name & Middle Initial & Last Name & Degree
Bill J. Wright, Ph.D.
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackilen Shannon, Ph.D.
Phone
503-494-4993
Email
shannoja@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Jackilen Shannon, Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Identifying and Caring for Individuals With Inherited Cancer Syndrome
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