Breast CancerNCT02755779
Characterization of Breast Masses Incidentally Detected on Chest CT
An observational study of Breast Cancer, run by Tel Aviv Medical Center.
Trial summary
Although Computed tomography (CT) is not routinely used to evaluate beast masses, It is common to discover Incidental breast lesions on chest CT. The goal of this study is to investigate the incidence and appearance of incidentally discovered breast masses on chest CT. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2017
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Woman over 18
Who may be able to join
- Woman with incidentally discovered breast masses on chest CT
Who cannot join
- Male gender
- Known breast cancer
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Characterization of Breast Masses Incidentally Detected on Chest CT - a Prospective Study
Although Computed tomography (CT) is not routinely used to evaluate beast masses, It is common to discover Incidental breast lesions on chest CT.
The goal of this study is to investigate the incidence and appearance of incidentally discovered breast masses on chest CT.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient enrollment
Enrolling 100 patients with breast masses to study
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoav Amitai, Tel Aviv Medical Center
- Investigators
- Yoav Amitai, Dr, Principal investigator, Sourasky medical center Tel aviv
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755779
- Sponsor's protocol ID
- 0067-16-TLV
- Status last verified
- Apr 2016
- First submitted
- 27 Apr 2016
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Breast Masses Incidentally Detected on Chest CT - a Prospective Study
- ClinicalTrials.gov ID
- NCT02755779
- Acronym / sponsor ID
- 0067-16-TLV
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel Aviv Medical CenterUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 29 Apr 2016 (estimated)
- 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.
Although Computed tomography (CT) is not routinely used to evaluate beast masses, It is common to discover Incidental breast lesions on chest CT.
The goal of this study is to investigate the incidence and appearance of incidentally discovered breast masses on chest CT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Woman over 18
Key inclusion criteria (1 listed)
- Woman with incidentally discovered breast masses on chest CT
Key exclusion criteria (2 listed)
- Male gender
- Known breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient enrollment
Time frame: One year
Enrolling 100 patients with breast masses to study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- 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.
Yoav Amitai, Dr principal investigator
Sourasky medical center Tel aviv
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Tel Aviv Medical Center.
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 1 inclusion and 2 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 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yoav Amitai, Dr (+972544771715, yoavslava@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient enrollment (time frame: One year). 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 2 May 2016.