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Recruiting NCT04494945

Identifying and Caring for Individuals With Inherited Cancer Syndrome

No phase Interventional BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome Breast Ductal Carcinoma In Situ Hematopoietic and Lymphoid System Neoplasm Hereditary Neoplastic Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen Collection, Genetic Counseling, Genetic Testing, Survey Administration.
Who it may be relevant to
Registry conditions: BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphoid System Neoplasm, Hereditary Neoplastic Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes

Overview

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.

Interventions

  • Procedure Biospecimen Collection
    Undergo collection of saliva sample
  • Other Genetic Counseling
    Receive genetic counseling if testing results are positive
  • Other Genetic Testing
    Undergo genetic testing
  • Other Survey Administration
    Complete a survey

Primary outcome measures

  • Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations [Time frame: 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]
  • Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging [Time frame: Up to 5 years]
  • Cascade screening rate among Lynch or HBOC positive carriers [Time frame: Up to 5 years]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 2 centers
  • Providence Portland Medical Center — Portland
  • OHSU Knight Cancer Institute — Portland

Identifiers

NCT: NCT04494945 · STUDY00020629 · NCI-2020-04627 · STUDY00020629 · U01CA232819

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗