Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04494945
Other study ID # STUDY00020629
Secondary ID NCI-2020-04627ST
Status Recruiting
Phase N/A
First received
Last updated
Start date March 9, 2020
Est. completion date June 10, 2030

Study information

Verified date March 2024
Source OHSU Knight Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 27500
Est. completion date June 10, 2030
Est. primary completion date June 10, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States OHSU Knight Cancer Institute Portland Oregon
United States Providence Portland Medical Center Portland Oregon

Sponsors (3)

Lead Sponsor Collaborator
OHSU Knight Cancer Institute National Cancer Institute (NCI), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 5 years
Primary 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. Up to 5 years
Primary 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. Up to 5 years
Primary 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). Up to 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT06030427 - Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT05660421 - Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors Phase 2
Suspended NCT04060849 - Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY Phase 1
Recruiting NCT06192875 - A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
Completed NCT04122118 - Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor N/A
Active, not recruiting NCT04940299 - Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma Phase 2
Active, not recruiting NCT03168737 - 18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients Phase 1
Active, not recruiting NCT06062901 - An Educational Intervention on Provider Knowledge for the Support of Cancer Survivors N/A
Active, not recruiting NCT02444741 - Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer Phase 1/Phase 2
Terminated NCT04081298 - eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors N/A
Active, not recruiting NCT04555837 - Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer Phase 1/Phase 2
Completed NCT04983901 - PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN Phase 2
Active, not recruiting NCT04602026 - The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer N/A
Recruiting NCT04871542 - Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Active, not recruiting NCT04592250 - Financial Toxicity in Cancer Patients
Recruiting NCT05112614 - Role of Gut Microbiome in Cancer Therapy
Active, not recruiting NCT04296305 - Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain Phase 4
Recruiting NCT05873608 - Communication Issues in Patient and Provider Discussions of Immunotherapy N/A
Recruiting NCT02464696 - Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure N/A