Mammary TumorPhase 2NCT01522300
Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité Tomos Study- Contribution of Tomosynthesis In Locoregional Pretherapeutic Staging of a Breast Tumor: Multicentricity Search
A Phase 2 study testing Evaluation of the Tomosynthesis and Avaluation of a medical device: the tomosynthesis in people with Mammary Tumor, run by Centre Jean Perrin at 1 site in France.
Trial summary
The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis in detecting the multicentricity of mammary tumor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mammary Tumor
- What is being tested?
- Evaluation of the Tomosynthesis and Avaluation of a medical device: the tomosynthesis
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Aug 2013
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years.
- Patients with a breast tumor, regardless of the stage and size
- Compulsory affiliation to a social security system.
- Obtaining informed consent in writing, signed and dated.
Who cannot join
- Patients with cognitive or psychiatric disorders.
- Patient deprived of liberty by a court or administrative.
- Patients with indications against the achievement of MRI, mammography and tomosynthesis
- Pregnant Women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité
The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis in detecting the multicentricity of mammary tumor.
Read the detailed description
The secondaries objectives of the study are:
- Sensitivity and specificity in detecting multifocality of breast tumor
- Sensitivity and specificity of Tomosynthesis in the detection of contralateral tumors
- Predetermination of potential targets for ultrasound
- Conditions
- Mammary Tumor
- Being tested
- Evaluation of the Tomosynthesis, Avaluation of a medical device: the tomosynthesis
- Keywords
- Tomosynthesis, breast cancer, specificity, sensitivity, To assess efficacy of Tomosynthesis by evaluating its sensitivity and specificity in detecting the multicentricity of mammary tumor
- Medical subject headings
- Breast Neoplasms, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the TomosynthesisOther
An exam by tomosynthesis will be realised at the inclusion of the patient in the study.
Avaluation of a medical device: the tomosynthesisOther
An exam by tomosynthesis will be realised at the inclusion of the patient in the study
What is being measured
The primary outcome is the main question the study is designed to answer.
To calculate the sensitivity and specificity of both types of imaging (mammography and Tomosynthesis) with respect to number of tumors multicentric and multifocal identified through MRI.
To calculate the sensitivity and specificity of both types of imaging (mammography and Tomosynthesis) with respect to number of tumors multicentric and multifocal identified through MRI. The other parameters VPN, VPP will also be calculated and discussed.
Measured: January 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: No more inclusions since august 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammary TumorStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522300
- Sponsor's protocol ID
- TOMOS
- Status last verified
- Nov 2013
- First submitted
- 18 Jan 2012
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité
- ClinicalTrials.gov ID
- NCT01522300
- Acronym / sponsor ID
- TOMOS
- Conditions
- Mammary Tumor
- Keywords
- Tomosynthesis, breast cancer, specificity, sensitivity, To assess efficacy of Tomosynthesis by evaluating its sensitivity and specificity in detecting the multicentricity of mammary tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No more inclusions since august 2013
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 31 Jan 2012 (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.
The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis in detecting the multicentricity of mammary tumor.
Detailed description
The secondaries objectives of the study are:
- Sensitivity and specificity in detecting multifocality of breast tumor
- Sensitivity and specificity of Tomosynthesis in the detection of contralateral tumors
- Predetermination of potential targets for ultrasound
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age> 18 years.
- Patients with a breast tumor, regardless of the stage and size
- Compulsory affiliation to a social security system.
- Obtaining informed consent in writing, signed and dated.
Key exclusion criteria (4 listed)
- Patients with cognitive or psychiatric disorders.
- Patient deprived of liberty by a court or administrative.
- Patients with indications against the achievement of MRI, mammography and tomosynthesis
- Pregnant Women
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 |
|---|---|---|
| Evaluation of the TomosynthesisAn exam by tomosynthesis will be realised at the inclusion of the patient in the study. | Other | – |
| Avaluation of a medical device: the tomosynthesisAn exam by tomosynthesis will be realised at the inclusion of the patient in the study | Other | – |
Primary outcome
To calculate the sensitivity and specificity of both types of imaging (mammography and Tomosynthesis) with respect to number of tumors multicentric and multifocal identified through MRI.
Time frame: January 2013
To calculate the sensitivity and specificity of both types of imaging (mammography and Tomosynthesis) with respect to number of tumors multicentric and multifocal identified through MRI. The other parameters VPN, VPP will also be calculated and discussed.
Results and safety
The study was stopped early (reason given: No more inclusions since august 2013). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
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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?
A Phase 2 study testing Evaluation of the Tomosynthesis and Avaluation of a medical device: the tomosynthesis in people with Mammary Tumor, run by Centre Jean Perrin at 1 site in France.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 21 Nov 2013. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No more inclusions since august 2013). 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?
To calculate the sensitivity and specificity of both types of imaging (mammography and Tomosynthesis) with respect to number of tumors multicentric and multifocal identified through MRI. (time frame: January 2013). 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 21 Nov 2013.