Breast CancerBCTNCT02310711
Multi-scale Modeling of Breast Conserving Therapy
An observational study of Breast Cancer, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The proposed study is a single-center, prospective, pilot, observation study to tabulate and measure the changes that occur during treatment and healing for breast conserving therapy (BCT) in women with non-metastatic breast cancer for comparison to the multiscale model of breast lumpectomy and healing in order to… Read more about this study
- Who is it for?
- Ages 30 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Aug 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 30 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with breast cancer who are having BCT and who satisfy the following criteria will be considered for participation in this study.
Who may be able to join
- Adult females ≥ age 30 years
- Have early stage (Stage I, II), non-metastatic breast cancer
- Planned to receive BCT
- Have received a pre-operative mammogram within 30 days of surgery
- Have received pre-operative magnetic resonance imaging (MRI) within 30 days of surgery
- Planned to receive post-surgery radiotherapy by whole breast radiotherapy
- Signed informed consent form prior to any research assessment
Who cannot join
- Adult females younger than 30 years of age
- Previous breast cancer
- Neo-adjuvant therapy for breast cancer
- Pregnant or nursing females
- Participation in a study of investigational drug in the previous 30 days or 5 half-lives of the investigational drug
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hopsital
Houston, Texas, 77030
Linda W Moore, 713-441-6144, lwmoore@houstonmethodist.org
Barbara Bass, MD
About this study
Official title: A Pilot Study for the Identification of Targets for Clinical Improvement in Breast Conserving Therapy
The proposed study is a single-center, prospective, pilot, observation study to tabulate and measure the changes that occur during treatment and healing for breast conserving therapy (BCT) in women with non-metastatic breast cancer for comparison to the multiscale model of breast lumpectomy and healing in order to identify targets for improving BCT. The study will be comprised of 12 de novo breast cancer patients with non-metastatic breast cancer undergoing BCT. Subjects will be enrolled in the study during the 3 weeks prior to receiving their BCT surgery and will be followed for six months after the BCT surgery. A total of 6 visits (not including the surgery) are planned.
Read the detailed description
This is a single-center, prospective, pilot observation study. Eligible subjects who enroll in this study will begin at the time of informed consent, which will occur during the pre-operative, surgical evaluation time. Once consented, a 3-dimensional 180° camera surface image will be taken and a pain-scale score will be completed. Data from the medical history will be recorded. As standard of care, the surgery will be scheduled and performed. Following surgery, a series of 5 standard of care visits will occur over the subsequent 6 months, that will include research measures of local ultrasound x5 and 3-dimensional surface imaging x3. The pain scale score will be administered pre and post ultrasound on the 5 post-operative visits. A judging of the cosmesis will take place at weeks 10 and 26 by independent surgeons. The participant's role in the study will be completed after the week 24 visit.
- Conditions
- Breast Cancer
- Being tested
- Standard of Care
- Keywords
- Breast, Mastectomy, Lumpectomy, Breast Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Standard of care for early stage breast cancer is breast conserving therapy at this center.
Other concomitant standard of care treatment • Radiation therapy to the whole breast
- 45-50 Gy delivered over 25-28 fractions with a boost to the tumor bed of 10-16 Gy delivered over 5-8 fractions
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Endpoint
The proportion of subjects with ≥60% agreement between the surgical/healing outcome of the lumpectomy and breast surface contour and the predicted changes from the multi-scale model.
Measured: Six-month Post-Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startMay 2012
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Bass, The Methodist Hospital Research Institute
- Investigators
- Barbara Bass, MD, Principal investigator, Chair, Department of Sugery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310711
- Sponsor's protocol ID
- Pro00006887
- Other IDs
- IRB0112-0007, BCTMM01
- Acronym
- BCT
- Status last verified
- Oct 2018
- First submitted
- 1 Dec 2014
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan to share data to be determined.
Publications
Salmon R, Garbey M, Moore LW, Bass BL. Interrogating a multifactorial model of breast conserving therapy with clinical data. PLoS One. 2015 Apr 23;10(4):e0125006. doi: 10.1371/journal.pone.0125006. eCollection 2015.
PubMed 25906048
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the Identification of Targets for Clinical Improvement in Breast Conserving Therapy
- ClinicalTrials.gov ID
- NCT02310711
- Acronym / sponsor ID
- BCT / Pro00006887
- Conditions
- Breast Cancer
- Keywords
- Breast, Mastectomy, Lumpectomy, Breast Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 8 Dec 2014 (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 proposed study is a single-center, prospective, pilot, observation study to tabulate and measure the changes that occur during treatment and healing for breast conserving therapy (BCT) in women with non-metastatic breast cancer for comparison to the multiscale model of breast lumpectomy and healing in order to identify targets for improving BCT. The study will be comprised of 12 de novo breast cancer patients with non-metastatic breast cancer undergoing BCT. Subjects will be enrolled in the study during the 3 weeks prior to receiving their BCT surgery and will be followed for six months after the BCT surgery. A total of 6 visits (not including the surgery) are planned.
Detailed description
This is a single-center, prospective, pilot observation study. Eligible subjects who enroll in this study will begin at the time of informed consent, which will occur during the pre-operative, surgical evaluation time. Once consented, a 3-dimensional 180° camera surface image will be taken and a pain-scale score will be completed. Data from the medical history will be recorded. As standard of care, the surgery will be scheduled and performed. Following surgery, a series of 5 standard of care visits will occur over the subsequent 6 months, that will include research measures of local ultrasound x5 and 3-dimensional surface imaging x3. The pain scale score will be administered pre and post ultrasound on the 5 post-operative visits. A judging of the cosmesis will take place at weeks 10 and 26 by independent surgeons. The participant's role in the study will be completed after the week 24 visit.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer who are having BCT and who satisfy the following criteria will be considered for participation in this study.
Key inclusion criteria (7 listed)
- Adult females ≥ age 30 years
- Have early stage (Stage I, II), non-metastatic breast cancer
- Planned to receive BCT
- Have received a pre-operative mammogram within 30 days of surgery
- Have received pre-operative magnetic resonance imaging (MRI) within 30 days of surgery
Key exclusion criteria (5 listed)
- Adult females younger than 30 years of age
- Previous breast cancer
- Neo-adjuvant therapy for breast cancer
- Pregnant or nursing females
- Participation in a study of investigational drug in the previous 30 days or 5 half-lives of the investigational drug
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 |
|---|---|---|
| Standard of CareStandard of care for early stage breast cancer is breast conserving therapy at this center. Other concomitant standard of care treatment • Radiation therapy to the whole breast o 45-50 Gy delivered over 25-28 fractions with a boost to the tumor bed of 10-16 Gy delivered over 5-8 fractions | Other | – |
Primary outcome
Study Endpoint
Time frame: Six-month Post-Surgery
The proportion of subjects with ≥60% agreement between the surgical/healing outcome of the lumpectomy and breast surface contour and the predicted changes from the multi-scale model.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Background: PubMed 25906048Salmon R, Garbey M, Moore LW, Bass BL. Interrogating a multifactorial model of breast conserving therapy with clinical data. PLoS One. 2015 Apr 23;10(4):e0125006. doi: 10.1371/journal.pone.0125006. eCollection 2015.
- Individual participant dataSharing planned: Undecided. Plan to share data to be determined.
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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.
Barbara Bass, MD principal investigator
Chair, Department of Sugery
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 The Methodist Hospital Research Institute 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 5 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 10 Oct 2018. 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 Linda W. Moore (713-441-6144, lwmoore@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Endpoint (time frame: Six-month Post-Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02310711, which also lists 1 linked publication.
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 10 Oct 2018.