Identifying and Caring for Individuals With Inherited Cancer Syndrome

July 10, 2026 updated by: Jackie Shannon, OHSU Knight Cancer Institute

Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Bill J. Wright, Ph.D.
      • Portland, Oregon, United States, 97239
        • Recruiting
        • OHSU Knight Cancer Institute
        • Contact:
        • Principal Investigator:
          • Jackilen Shannon, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Screening (genetic testing)
Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
Other: Genetic Testing
Undergo genetic testing
Other Names:
  • genetic analysis
  • Genetic Examination
  • Genetic Test
Other: Survey Administration
Complete a survey
Procedure: Biospecimen Collection
Undergo collection of saliva sample
Other Names:
  • Biological Sample Collection
Other: Genetic Counseling
Receive genetic counseling if testing results are positive

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations
Time Frame: 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.
Up to 5 years
Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes
Time Frame: 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.
Up to 5 years
Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging
Time Frame: 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.
Up to 5 years
Cascade screening rate among Lynch or HBOC positive carriers
Time Frame: 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).
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OHSU Knight Cancer Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
Oregon Health and Science University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jackilen Shannon, Ph.D., OHSU Knight Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00020629 (Other Identifier: OHSU Knight Cancer Institute)
  • NCI-2020-04627 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U01CA232819 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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:

  • Meet all IRB requirements (IRB approval, exemption or nonhuman subjects research determination), as appropriate.
  • Use data only for the research described in their data request and/or IRB application/ protocol and obtain additional IRB approval if secondary studies are

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings