Hereditary CancerNCT03319290
Increase Surveillance for Breast and Ovarian Cancers, Also to Determine Targeted Risk-reducing and Preventative Strategies
An observational study of Hereditary Cancer, run by Data Collection Analysis Business Management at 1 site in United States.
Trial summary
Observational study is to increase surveillance for breast and ovarian cancers, also to determine targeted risk-reducing and preventative strategies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hereditary Cancer
- What is being tested?
- BRCA1 and BRCA2
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2017to 17 Oct 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Current standard operating procedures for providers
Who may be able to join
- Must be a Medical Practitioner
- Medical Doctor (MD)
- Doctor of Osteopathic (DO)
- Physician Assistant (PA)
- Advanced Practice Registered Nurse (APRN)
- Nurse Practitioner (NP)
- Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history
Who cannot join
- Government-funded insurance data cannot be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical Provider Experience Assessment Healthcare Decisions Post-Testing, Risk Reducing, and Preventative Strategies Using BRCA2 and BRCA2 Genetic Testing
Observational study is to increase surveillance for breast and ovarian cancers, also to determine targeted risk-reducing and preventative strategies.
Read the detailed description
The general design of this study is collecting data and reviewing the Principal Investigators' (P.I.) Standard Operating Procedures (SOP) on BRCA testing and changes made to their specific SOP.
- Conditions
- Hereditary Cancer
- Being tested
- BRCA1 and BRCA2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRCA1 and BRCA2Genetic
Genetic breast and ovarian cancer testing
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Structures and Processes
Plan of Care Changes due to BRCA testing. Provider based observational survey system on the health and well-being of patients and populations
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start17 Oct 2017
- Primary completion1 Oct 2020 (estimated)
- Study completion17 Oct 2020 (estimated)
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Data Collection Analysis Business Management
- Sponsor type
- University, hospital or other
- Collaborators
- PAS Research Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319290
- Sponsor's protocol ID
- PAS1460
- Status last verified
- Jan 2019
- First submitted
- 17 Oct 2017
- Last updated
- 23 Jan 2019
- Results posted
- 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 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Provider Experience Assessment Healthcare Decisions Post-Testing, Risk Reducing, and Preventative Strategies Using BRCA2 and BRCA2 Genetic Testing
- ClinicalTrials.gov ID
- NCT03319290
- Acronym / sponsor ID
- PAS1460
- Conditions
- Hereditary Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Data Collection Analysis Business ManagementUniversity, hospital or other
- Collaborators
- PAS Research Services
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 17 Oct 2020 (estimated)
- First posted
- 24 Oct 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.
Observational study is to increase surveillance for breast and ovarian cancers, also to determine targeted risk-reducing and preventative strategies.
Detailed description
The general design of this study is collecting data and reviewing the Principal Investigators' (P.I.) Standard Operating Procedures (SOP) on BRCA testing and changes made to their specific SOP.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Current standard operating procedures for providers
Key inclusion criteria (7 listed)
- Must be a Medical Practitioner
- Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history
Key exclusion criteria (1 listed)
- Government-funded insurance data cannot be included in the study.
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 |
|---|---|---|
| BRCA1 and BRCA2Genetic breast and ovarian cancer testing | Genetic | – |
Primary outcome
Provider Structures and Processes
Time frame: 36 months
Plan of Care Changes due to BRCA testing. Provider based observational survey system on the health and well-being of patients and populations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Data Collection Analysis Business Management at 1 site 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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 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 1 site 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?
Results are not available in the source record.
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?
Provider Structures and Processes (time frame: 36 months). 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 23 Jan 2019.