Clinical trial NCT04494945: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Oregon Health and Science University
First posted: 2020-07-31
Enrollment: 27500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations
timeFrame: Up to 5 years
measure: Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes
timeFrame: Up to 5 years
measure: Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging
timeFrame: Up to 5 years
measure: Cascade screening rate among Lynch or HBOC positive carriers
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Jackilen Shannon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: