Breast CancerNCT00749255
Collect Breast Cancer Patients' Digital Mammography Images With Corresponding Reports for the Development of Software
An observational study of Breast Cancer, run by WellSpan Health at 1 site in United States.
Trial summary
The purpose of this case collection effort is software design by R2 Technologies, Inc., The information received from Women's Imaging will be provided to the Case Collection, Data Management and Algorithm/software design and development teams who are responsible for the receipt of patient data and management of such… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jan 2011
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Known breast cancer patients
Who may be able to join
- subjects with known breast cancer ages 18 and over
- case images originating from Women's imaging or one of the affiliated screening centers. Raw images must be available for each image
- source documents or mammographic interpretation must be available
Who cannot join
- 17 or younger
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Imaging @ WellSpan Health
York, Pennsylvania, 17403
About this study
Official title: R2 Case Collection
The purpose of this case collection effort is software design by R2 Technologies, Inc., The information received from Women's Imaging will be provided to the Case Collection, Data Management and Algorithm/software design and development teams who are responsible for the receipt of patient data and management of such data; and creation, testing and validation of R2 Technologies, Inc., for Computer Aided Detection (CAD) and new digital image archiving software design.
Read the detailed description
The information is necessary for Sponsor development efforts and will be utilized as a viewing tool with supporting written documentation of the findings on each image itself. The information will be used to develop algorithms that will foster development of CAD software. The information in each image and/or accompanying written clinical case documentation will not be analyzed in any way for clinical events
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Digital archiver software
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FFDM | a sum of at least 200 cancer cases, mammographically visible, on at least one image view (including masses and calcifications) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startMay 2008
- Study completionJan 2011
Why it stopped: not enough personnel to conduct study at site
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Investigators
- Misty Hicks, RTRM, Principal investigator, Women's Imaging @ WellSpan Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749255
- Sponsor's protocol ID
- 0708052
- Status last verified
- Jan 2011
- First submitted
- 5 Sep 2008
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R2 Case Collection
- ClinicalTrials.gov ID
- NCT00749255
- Acronym / sponsor ID
- 0708052
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Digital archiver software
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: not enough personnel to conduct study at site
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- WellSpan HealthUniversity, hospital or other
- Study start
- May 2008
- Study completion
- Jan 2011 (actual)
- First posted
- 9 Sep 2008 (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 purpose of this case collection effort is software design by R2 Technologies, Inc., The information received from Women's Imaging will be provided to the Case Collection, Data Management and Algorithm/software design and development teams who are responsible for the receipt of patient data and management of such data; and creation, testing and validation of R2 Technologies, Inc., for Computer Aided Detection (CAD) and new digital image archiving software design.
Detailed description
The information is necessary for Sponsor development efforts and will be utilized as a viewing tool with supporting written documentation of the findings on each image itself. The information will be used to develop algorithms that will foster development of CAD software. The information in each image and/or accompanying written clinical case documentation will not be analyzed in any way for clinical events
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FFDM | – | –a sum of at least 200 cancer cases, mammographically visible, on at least one image view (including masses and calcifications) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Known breast cancer patients
Key inclusion criteria (3 listed)
- subjects with known breast cancer ages 18 and over
- case images originating from Women's imaging or one of the affiliated screening centers. Raw images must be available for each image
- source documents or mammographic interpretation must be available
Key exclusion criteria (1 listed)
- 17 or younger
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: not enough personnel to conduct study at site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
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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.
Misty Hicks, RTRM principal investigator
Women's Imaging @ WellSpan Health
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 Breast Cancer, run by WellSpan Health 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 3 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: stopped early, as of the sponsor's last update on 19 Jan 2011. 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?
The study was stopped early (reason given: not enough personnel to conduct study at site). 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.
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 19 Jan 2011.