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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 March 2013 |
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Main ID: |
NCT00539227 |
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Date of registration:
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02/10/2007 |
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Primary sponsor: |
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Public title:
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A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy
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Scientific title:
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A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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30 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00539227 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Gildy V. Babiera, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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M.D. Anderson Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients desiring prophylactic mastectomy with immediate reconstruction
2. Patients with Stage 0, I, or II breast cancer who are candidates for and desire
skin-sparing mastectomy with immediate reconstruction
3. Tumor location greater than or equal to 2.5 cm from the border of the NAC based on
preoperative imaging and/or clinical exam
4. Patients must sign an informed consent and be registered before the procedure is
performed
Exclusion Criteria:
1. Patients with cancer involvement of the NAC on clinical exam, defined as induration,
retraction, fixation, ulceration, or pathologic nipple discharge
2. Patients with subareolar tumor locations, tumors located < 2.5 cm from the border of
the NAC
3. Patients with Paget's disease of the nipple
4. Patients who have locally advanced breast cancer manifesting as inflammatory breast
cancer or gross involvement of the mastectomy skin
5. Patients with history of prior surgery involving a periareolar incision
6. Patients desiring a concomitant ipsilateral reduction mammoplasty at time of
mastectomy
7. Patients with macromastia as defined by the plastic surgeon
8. Patients with a body mass index (BMI) greater than 40 kg/m2
9. Patients who actively smoke
10. Patients with known collagen vascular disease
11. Patients with prior ipsilateral chest wall irradiation less than 12 months from their
time of surgery
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Behavioral: Questionnaire
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Procedure: NAC Sparing Mastectomy
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Primary Outcome(s)
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Nipple Sensation Evaluation (following NAC sparing mastectomy)
[Time Frame: Within first month postoperatively, then at 3 months, 6 month, 1 year, 2 years, and 5 years postoperatively (each interval +/- 1 month)]
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Secondary ID(s)
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2007-0194
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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