Hereditary CancerNCT03067389
Combined Breast Cancer Risk Study
An observational study of Hereditary Cancer, run by Myriad Genetic Laboratories, Inc. at 4 sites in United States.
Trial summary
A prospective, non-interventional study in women 18 to 84 years of age. Subjects will provide a sample for genetic testing and information about their medical and family history. The results of the genetic test will be combined with clinical data to validate a method of predicting breast cancer risk. Read more about this study
- Who is it for?
- Ages 18 to 84 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hereditary Cancer
- What is being tested?
- Diagnostic test
- How many people
- 553 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Feb 2016to 8 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women presenting at imaging centers for a breast cancer diagnostic assessment visit or preventative screening visit.
Who may be able to join
- Women without breast cancer:
- 18 to 84 years of age
- Western/Northern European, Central/Eastern European, or Ashkenazi ancestry
- No history of invasive breast cancer
- Women with a history of breast cancer:
- 18 to 84 years of age
- Western/Northern European, Central/Eastern European, or Ashkenazi ancestry
- Pathologically confirmed invasive breast cancer diagnosed within the past 12 months
Who cannot join
- Unwilling to provide written informed consent
- Women with history of ductal carcinoma in situ (DCIS).
- Patient has had a prior breast biopsy, exclusive of a breast biopsy diagnostic of breast cancer, that showed either hyperplasia, atypical hyperplasia, lobular carcinoma in situ (LCIS), or the specific histologic result is unknown to the patient
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Bethesda Health
Boynton Beach, Florida, 33437
The Breast Center of Northwest Arkansas
Fayetteville, Arkansas, 72703
Cuda Women's Health Center
Hyannis, Massachusetts, 02601
Elizabeth Wende Breast Care
Rochester, New York, 14620
About this study
Official title: Evaluation of a Combined Breast Cancer Risk Derived From a Polygenic Risk Score and the Tyrer-Cuzick Model
A prospective, non-interventional study in women 18 to 84 years of age. Subjects will provide a sample for genetic testing and information about their medical and family history. The results of the genetic test will be combined with clinical data to validate a method of predicting breast cancer risk.
Read the detailed description
This is a prospective, non- interventional study. Women presenting at imaging centers for routine breast cancer screening or breast cancer diagnostic assessment and who provide written informed consent will undergo genetic testing. Subjects will also provide information about their personal medical and cancer history and family cancer history. The results of the genetic test will be combined with the subject's clinical information, family history, and a risk assessment model to validate a new method of predicting breast cancer.
- Conditions
- Hereditary Cancer
- Being tested
- Diagnostic test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testDiagnostic test
Genetic diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| History of invasive breast cancer | Subjects with a diagnosis of invasive breast cancer within the past 12 months will provide a blood or saliva sample for genetic diagnostic testing and provide information about their personal medical and cancer history and family cancer history. Receives: Diagnostic Test: Diagnostic test | |
| No history of invasive breast cancer | Subjects with no history of breast cancer will provide a blood or saliva sample for genetic diagnostic testing and provide information about their personal medical and cancer history and family cancer history. Receives: Diagnostic Test: Diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that a combined breast cancer risk derived from a polygenic risk score and a breast cancer risk assessment model is a better predictor of breast cancer than the risk assessment model alone
Measured: Baseline
Secondary outcomes (1)
To derive a distribution of polygenic risk scores in an unselected patient population
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start6 Feb 2016
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 553 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myriad Genetic Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Holmsn, MD, Study director, Myriad Genetics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067389
- Sponsor's protocol ID
- HCP-018
- Status last verified
- Jan 2019
- First submitted
- 24 Feb 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Combined Breast Cancer Risk Derived From a Polygenic Risk Score and the Tyrer-Cuzick Model
- ClinicalTrials.gov ID
- NCT03067389
- Acronym / sponsor ID
- HCP-018
- Conditions
- Hereditary Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 553 participants (actual)
- Lead sponsor
- Myriad Genetic Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2016 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, non-interventional study in women 18 to 84 years of age. Subjects will provide a sample for genetic testing and information about their medical and family history. The results of the genetic test will be combined with clinical data to validate a method of predicting breast cancer risk.
Detailed description
This is a prospective, non- interventional study. Women presenting at imaging centers for routine breast cancer screening or breast cancer diagnostic assessment and who provide written informed consent will undergo genetic testing. Subjects will also provide information about their personal medical and cancer history and family cancer history. The results of the genetic test will be combined with the subject's clinical information, family history, and a risk assessment model to validate a new method of predicting breast cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| History of invasive breast cancer | – | Diagnostic Test: Diagnostic testSubjects with a diagnosis of invasive breast cancer within the past 12 months will provide a blood or saliva sample for genetic diagnostic testing and provide information about their personal medical and cancer history and family cancer history. |
| No history of invasive breast cancer | – | Diagnostic Test: Diagnostic testSubjects with no history of breast cancer will provide a blood or saliva sample for genetic diagnostic testing and provide information about their personal medical and cancer history and family cancer history. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women presenting at imaging centers for a breast cancer diagnostic assessment visit or preventative screening visit.
Key inclusion criteria (8 listed)
- 18 to 84 years of age
- Western/Northern European, Central/Eastern European, or Ashkenazi ancestry
- No history of invasive breast cancer
- 18 to 84 years of age
- Western/Northern European, Central/Eastern European, or Ashkenazi ancestry
Key exclusion criteria (3 listed)
- Unwilling to provide written informed consent
- Women with history of ductal carcinoma in situ (DCIS).
- Patient has had a prior breast biopsy, exclusive of a breast biopsy diagnostic of breast cancer, that showed either hyperplasia, atypical hyperplasia, lobular carcinoma in situ (LCIS), or the specific histologic result is unknown to the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic testGenetic diagnostic test | Diagnostic test | History of invasive breast cancer, No history of invasive breast cancer |
Primary outcome
To demonstrate that a combined breast cancer risk derived from a polygenic risk score and a breast cancer risk assessment model is a better predictor of breast cancer than the risk assessment model alone
Time frame: Baseline
1 secondary outcome
To derive a distribution of polygenic risk scores in an unselected patient population
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Hereditary Cancer
RecruitingObservational study
Feasibility Study of a Chatbot AI-Driven Preliminary Screening System for Hereditary Cancer Syndromes
Hereditary Cancer Syndromes
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Not yet recruitingPhase 2
Combination of Avutometinib and Defactinib for Treatment of Relapsed, Refractory, Metastatic, or Unresectable Malignant Peripheral Nerve Sheath Tumor
MPNST (Malignant Peripheral Nerve Sheath Tumor)
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Holmsn, MD study director
Myriad Genetics, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Cancer, run by Myriad Genetic Laboratories, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate that a combined breast cancer risk derived from a polygenic risk score and a breast cancer risk assessment model is a better predictor of breast cancer than the risk assessment model alone (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.