- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02216136
Tumor: Breast Ratio Study (T:B)
A Prospective Trial to Assess Tumor :Breast Ratio and Patient Satisfaction in Following Lumpectomy Versus Mastectomy With Reconstruction
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient must be scheduled to undergo breast conservation therapy (BCT), mastectomy or mastectomy with immediate reconstruction (defined as initiating the reconstructive process at time of mastectomy) for ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), and early stage breast cancer (Clinical Stages IA-IIB). Stage IIB tumors are 2-5 cm with micrometastases 0.2 to 2.0 cm in lymph nodes; or 2-5 cm tumor with 1-3 positive axillary or internal mammary lymph nodes, or >5 cm with no lymph node involvement. Clinical staging, based on imaging and physical exam will be used for enrollment. Patients that are upstaged due to unexpected findings at the time of surgery/assessment of surgical pathology will be excluded at that time. For staging reference please see http://www.cancer.gov/cancertopics/pdq/treatment/breast/patient/page2#keypoint13
- If multifocal/multicentric disease of the ipsilateral breast is encountered and patients are still deemed eligible for BCT or mastectomy per standard of care, then the tumor area will be calculated as the total volumes of the identified foci.
- Patient must be between 18-72 years old
- Patient must be able to understand and willing to sign a written informed consent document
Exclusion Criteria:
- Cognitive impairment
- History of radiation to the chest wall or breasts
- Patients unable to undergo MRI due to metallic implant or claustrophobia
- Patients that are pregnant since breast MRI is contraindicated
- History of previous breast surgery other than primary cosmetic augmentation or breast reduction
- Identification of a concurrent or synchronous contralateral cancer during the enrollment period
- Any patient that would not have been considered for BCT or reconstruction
- BCT patients planning to proceed with reconstruction during their study participation timeline
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Breast Conservation Cohort
Breast Conservation group (Group A) with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment.
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Mastectomy and Reconstruction Cohort
Mastectomy and Reconstruction group (Group B): This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery).
They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction.
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Mastectomy Only Cohort
Mastectomy Only Cohort: This group will have mastectomy without reconstruction.
They may or may not require chemotherapy and radiation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life as Measured by the Breast Q
Time Frame: Compare preoperative values with postoperative values (up to 4 years)
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The Breast Q is a comprehensive and specific quality of life instrument that allows for patient self-assessment prior to and following breast surgery. Comprised of quality of life and satisfaction domains, and generates domain-specific Q-scores (0-100) constructed using Rasch analysis. The higher the score, the more satisfied the participant was. -Collected preoperatively (no more than 3 months prior to surgery) and postoperatively (approximately 6 months after conclusion of radiotherapy in the Breast Conservation Cohort and >=3 months after the final balancing reconstructive intervention in the Mastectomy and Reconstruction Cohort. |
Compare preoperative values with postoperative values (up to 4 years)
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Collaborators and Investigators
Investigators
- Principal Investigator: Terence M. Myckatyn, M.D., Washington University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201404004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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