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Identifying and Caring for Individuals With Inherited Cancer Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04494945
Recruitment Status : Not yet recruiting
First Posted : July 31, 2020
Last Update Posted : July 31, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Oregon Health and Science University
Information provided by (Responsible Party):
Paul T Spellman, Ph.D., OHSU Knight Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Hereditary Breast and Ovarian Cancer Syndrome Hereditary Neoplastic Syndrome Lynch Syndrome Procedure: Biospecimen Collection Other: Genetic Counseling Other: Genetic Testing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : June 10, 2025
Estimated Study Completion Date : June 10, 2030


Arm Intervention/treatment
Screening (genetic testing)
Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
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 Names:
  • genetic analysis
  • Genetic Examination
  • Genetic Test




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Consent to this project, either hard or electronic signature
  • Creation of secure Medable account
  • Electronically signed Healthy Oregon Project (HOP) consent form (found within Medable app)
  • Choosing to submit a deoxyribonucleic acid (DNA) sample

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04494945


Locations
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United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Contact: Bill J. Wright, Ph.D.       Bill.Wright@providence.org   
Principal Investigator: Bill J. Wright, Ph.D.         
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Contact: Paul T. Spellman, Ph.D.       spellmap@ohsu.edu   
Principal Investigator: Paul T. Spellman, Ph.D.         
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Oregon Health and Science University
Investigators
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Principal Investigator: Paul T Spellman, Ph.D. OHSU Knight Cancer Institute
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Responsible Party: Paul T Spellman, Ph.D., Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT04494945    
Other Study ID Numbers: STUDY00020629
NCI-2020-04627 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
STUDY00020629 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
U01CA232819 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms, Hereditary Nonpolyposis
Hereditary Breast and Ovarian Cancer Syndrome
Neoplasms
Neoplastic Syndromes, Hereditary
Syndrome
Disease
Pathologic Processes
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Breast Neoplasms
Breast Diseases
Skin Diseases