This Study Has Been Designed to Compile Information on the Efficacy of the Partial Breast Intracavitary Brachytherapy in the Post Market Setting.NCT01813825
A Single Site Prospective, Non-randomized Study of Partial Breast Intracavitary Brachytherapy Devices to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities.
An observational study of This Study Has Been Designed to Compile Information on the Efficacy of the Partial Breast Intracavitary Brachytherapy in the Post Market Setting., run by St. Vincent's Medical Center at 1 site in United States.
Trial summary
A registry is an observation database. Participation in this registry does not require any additional or different procedures or drugs other than those you would normally receive for breast cancer. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- This Study Has Been Designed to Compile Information on the Efficacy of the Partial Breast Intracavitary Brachytherapy in the Post Market Setting.
- What is being tested?
- Registry
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Dec 2015
- How long will I take part?
- 7 Years
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Females, with Breast Cancer Tis, T1,N0,M0. Negative Surgival Margens
Who may be able to join
- Be 45 years of age or older
- Be a Tis, T1, N0 M0 - American Joint Committee Classification
- Have negative surgical margins (NSABP definition) after final surgery
- Should have adequate skin spacing between balloon surface and surface of the skin (>=7mm)
- DCIS
Who cannot join
- Be pregnant or breast-feeding.(If appropriate, patient must use birth control during the study)
- Have collagen-vascular disease
- Have extensive intraductal component (Harvard Definition,>25% DCIS)
- Have infiltrating lobular histology
Trial locations and contacts
1 site in 1 country.
Deborah Fang, MD contact
United States1 site, 1 recruiting
- Recruiting
St. Vincent's Medical Center
Bridgeport, Connecticut, 06606
Deborah Fang, MD
Deborah Fang, MD
About this study
A registry is an observation database. Participation in this registry does not require any additional or different procedures or drugs other than those you would normally receive for breast cancer. Registry databases are used to identify trends in medical care that help the medical community identify optimal care for different diseases.
The data will be compiled on the safety and performance of the Partial Breast Brachytherapy Applicator based on the information collected about the treatment and follow up visits.
Read the detailed description
PURPOSE OF STUDY
The patient understand that she has cancer of the breast. The patient understand that is offered the opportunity to participate in a registry study to collect data on the FDA approved device,Partial Breast Brachytherapy Applicator. Partial Breast Brachytherapy is a treatment method that works by delivering radiation from inside the breast directly to the tissue where cancer is most likely to recur. The Partial Breast Brachytherapy Applicator is a device that has tiny catheters or wires that fit inside the lumpectomy cavity (the space left after the tumor is removed). Radioactive sources (seed) are placed within the device by a computer controlled machine. This radioactive source will deliver the radiation therapy to the breast
A registry is an observation database. Participation in this registry does not require any additional or different procedures or drugs other than those you would normally receive for breast cancer. Registry databases are used to identify trends in medical care that help the medical community identify optimal care for different diseases.
PROCEDURES
If the patient agree to take part in this registry, data will be compiled on the safety and performance of the Partial Breast Brachytherapy Applicator based on the information collected about the treatment and follow up visits.
POTENTIAL RISKS AND DISCOMFORTS
There is no medical risk to the patient if she takes part in this registry, as she will continue to receive the same medical care as provided by her medical team.
POTENTIAL BENEFITS:
It is not possible to state that the patient will benefit from this study. The information obtained from study may be used scientifically and may possibly be helpful to others.
ALTERNATIVES TO TREATMENT
The patient participation is voluntary and she may choose not to participate in this study or she may stop at any time. The patient choice will not affect doctors from providing care. The patient will not lose any benefits if she choose not to participate or if you withdraw from this study. She is free to seek care from a doctor of her choice at any time.
- Being tested
- Registry
- Keywords
- Mammosite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryOther
| Study group | Role | What they receive |
|---|---|---|
| Female >=45 years, negative margins, DCIS | Not described Receives: Other: Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Single Site Prospective, Non Randomized Study of Partial Breast Intracavitary Brachytherapy Devices To Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities
The efficacy of the treatment will be measured by using the overall survival. The following endpoints will also be reported and analyzed:Disease Free Survival, Cause Specific Survival, Ipsilateral Breast Failure, Contralateral Breast Failure.
Measured: 1-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startNov 2004
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study Has Been Designed to Compile Information on the Efficacy of the Partial Breast Intracavitary Brachytherapy in the Post Market Setting.Studies 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
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- St. Vincent's Medical Center
- Responsible party
- Principal investigator, Deborah Fang, MD, St. Vincent's Medical Center
- Investigators
- Deborah Fang, MD, Principal investigator, St. Vincent's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813825
- Sponsor's protocol ID
- SVMC 104
- Status last verified
- Mar 2013
- First submitted
- 13 Mar 2013
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Site Prospective, Non-randomized Study of Partial Breast Intracavitary Brachytherapy Devices to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities.
- ClinicalTrials.gov ID
- NCT01813825
- Acronym / sponsor ID
- SVMC 104
- Keywords
- Mammosite
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- St. Vincent's Medical Center
- Study start
- Nov 2004
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 19 Mar 2013 (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.
A registry is an observation database. Participation in this registry does not require any additional or different procedures or drugs other than those you would normally receive for breast cancer. Registry databases are used to identify trends in medical care that help the medical community identify optimal care for different diseases.
The data will be compiled on the safety and performance of the Partial Breast Brachytherapy Applicator based on the information collected about the treatment and follow up visits.
Detailed description
PURPOSE OF STUDY
The patient understand that she has cancer of the breast. The patient understand that is offered the opportunity to participate in a registry study to collect data on the FDA approved device,Partial Breast Brachytherapy Applicator. Partial Breast Brachytherapy is a treatment method that works by delivering radiation from inside the breast directly to the tissue where cancer is most likely to recur. The Partial Breast Brachytherapy Applicator is a device that has tiny catheters or wires that fit inside the lumpectomy cavity (the space left after the tumor is removed). Radioactive sources (seed) are placed within the device by a computer controlled machine. This radioactive source will deliver the radiation therapy to the breast
A registry is an observation database. Participation in this registry does not require any additional or different procedures or drugs other than those you would normally receive for breast cancer. Registry databases are used to identify trends in medical care that help the medical community identify optimal care for different diseases.
PROCEDURES
If the patient agree to take part in this registry, data will be compiled on the safety and performance of the Partial Breast Brachytherapy Applicator based on the information collected about the treatment and follow up visits.
POTENTIAL RISKS AND DISCOMFORTS
There is no medical risk to the patient if she takes part in this registry, as she will continue to receive the same medical care as provided by her medical team.
POTENTIAL BENEFITS:
It is not possible to state that the patient will benefit from this study. The information obtained from study may be used scientifically and may possibly be helpful to others.
ALTERNATIVES TO TREATMENT
The patient participation is voluntary and she may choose not to participate in this study or she may stop at any time. The patient choice will not affect doctors from providing care. The patient will not lose any benefits if she choose not to participate or if you withdraw from this study. She is free to seek care from a doctor of her choice at any time.
Study design
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female >=45 years, negative margins, DCIS | – | Other: Registry |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females, with Breast Cancer Tis, T1,N0,M0. Negative Surgival Margens
Key inclusion criteria (5 listed)
- Be 45 years of age or older
- Be a Tis, T1, N0 M0 - American Joint Committee Classification
- Have negative surgical margins (NSABP definition) after final surgery
- Should have adequate skin spacing between balloon surface and surface of the skin (>=7mm)
- DCIS
Key exclusion criteria (4 listed)
- Be pregnant or breast-feeding.(If appropriate, patient must use birth control during the study)
- Have collagen-vascular disease
- Have extensive intraductal component (Harvard Definition,>25% DCIS)
- Have infiltrating lobular histology
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 |
|---|---|---|
| Registry | Other | Female >=45 years, negative margins, DCIS |
Primary outcome
A Single Site Prospective, Non Randomized Study of Partial Breast Intracavitary Brachytherapy Devices To Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities
Time frame: 1-4 weeks
The efficacy of the treatment will be measured by using the overall survival. The following endpoints will also be reported and analyzed:Disease Free Survival, Cause Specific Survival, Ipsilateral Breast Failure, Contralateral Breast Failure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
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.
Deborah Fang, MD contact
Deborah Fang, MD principal investigator
St. Vincent's Medical Center
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 This Study Has Been Designed to Compile Information on the Efficacy of the Partial Breast Intracavitary Brachytherapy in the Post Market Setting., run by St. Vincent's Medical Center 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 5 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: status not confirmed, as of the sponsor's last update on 19 Mar 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 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?
Contact Deborah Fang, MD (203-576-5085), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Single Site Prospective, Non Randomized Study of Partial Breast Intracavitary Brachytherapy Devices To Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities (time frame: 1-4 weeks). 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 19 Mar 2013.