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Omitting vs. Doing Intraoperative Frozen Section Biopsy for Margin Status in Breast Conserving Surgery (OFF-MAP)

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ClinicalTrials.gov Identifier: NCT03975179
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Byung Joo Chae, Samsung Medical Center

Brief Summary:
  • Study phase: 3
  • Indication: Breast cancer patients undergoing breast conserving surgery
  • Primary objectives: To determine the effect of selective omission of intraoperative margin evaluation via frozen section on margin positive rate Secondary objectives: To determine the effect of selective omission of intraoperative margin evaluation via frozen section on reoperation rate, local recurrence rate, operation time, resection volume, medical cost and patient quality-of life
  • Hypothesis: Omitting intraoperative margin evaluation via frozen section biopsy in selected breast cancer patients does not increase margin positive rate
  • Study design: Randomized controlled trial
  • Sample size: 1292 patients
  • Procedures: breast conserving surgery +/- margin frozen section biopsy (+/- additional resection)

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Omission of intraoperative frozen section biopsy for margin status Procedure: Frozen section biopsy for margin status Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial for Doing vs. Omitting Intraoperative Frozen Section Biopsy For Resection MArgin Status in Selected Patients Undergoing Breast Conserving Surgery
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Frozen section omission Procedure: Omission of intraoperative frozen section biopsy for margin status
Omitting intraoperative frozen section biopsy for margin status in patients undergoing breast conserving surgery

Active Comparator: Frozen section Procedure: Frozen section biopsy for margin status
Performing intraoperative frozen section biopsy for margin status in patients undergoing breast conserving surgery




Primary Outcome Measures :
  1. Resection margin status [ Time Frame: 2 weeks after primary surgery ]
    Margin status data will be obtained from pathology report. Positive margin is defined as "no ink on tumor" for DCIS and invasive cancer. A close margin of any distance is defined as a negative margin


Secondary Outcome Measures :
  1. Reoperation rate [ Time Frame: 2 months after primary surgery ]
    Additional operation for re-excision of margin is defined as a reoperation. The decision for a reoperation is determined by the surgeon. Data regarding reoperation and reason for reoperation must be recorded.

  2. Operation time [ Time Frame: Immediately after primary surgery ]
    Operation time is defined by time from incision to closure, which will be obtained from anesthesia report.

  3. Cost effectiveness [ Time Frame: 3 months after primary surgery ]
    Data for in-hospital cost including cost for re-excision will be collected. Opportunity cost due to elongated surgery time and labor costs from the pathology department will also be calculated and included.

  4. Resection volume [ Time Frame: 3 months after primary surgery ]
    Resected volume is calculated from gross specimen measurements of pathology report (volume = width/2 * height/2 * depth/2). When additional resection is performed, resected volumes are reported separately.

  5. Local recurrence [ Time Frame: 5 years after primary surgery ]
    Local recurrence is defined as pathologically defined ipsilateral breast tumor recurrence. Median follow up period is 5 years. Annual clinical examination, mammography and breast sonography is warranted for evaluation of local recurrence.


Other Outcome Measures:
  1. Number of patients with residual cancer after reoperation [ Time Frame: 3 months after primary surgery ]
    Whether residual cancer cells are present in re-operation specimens for excision of resection margin. Thorough microscopic examinations are warranted for this endpoint.

  2. Number of patients with residual cancer after re-excision according to frozen section biopsy result [ Time Frame: 3 months after primary surgery ]
    Whether residual cancer cells are present in additional resection specimens performed according to frozen section biopsy result of resection margin. Thorough microscopic examinations are warranted for this endpoint.

  3. Patient quality-of-life assessment: BREAST-Q survey [ Time Frame: 1 year after primary surgery ]

    Quality-of-life assessment is performed by using the Korean version of the BREAST-Q survey for breast conserving therapy which is a questionnaire for patient reported outcome measurement. An assessment for physical well-being, psychosocial well-being, sexual well-being, satisfaction with breasts/outcome/care will be done. Each subscale will be reported with a scale of 0 - 100. A higher value is considered a better outcome. No total score will be calculated.

    The survey module is filled out pre- and post-operatively. Postoperative module is scored 1 month postoperatively (within one month of date of final operation but before start of radiotherapy) and within 2 months of completion of radiotherapy.




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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed breast cancer by core needle biopsy with clinical stage T1-3 by American Joint Committee on Cancer(AJCC) 8th edition
  • Candidate of breast-conserving surgery
  • Daughter nodule within ≤ 1cm distance of main mass on breast MRI
  • Non-mass enhancement extent within ≤ 1cm distance of main mass on breast MRI
  • Ability to understand and willing to sign a written informed consent document : Patients who consent about deciding whether frozen biopsy will be performed by randomization

Exclusion Criteria:

  • cT4 tumors (AJCC 8th edition)
  • Cancer diagnosis confirmed by vacuum-assisted biopsy or surgical biopsy
  • Initial operation plan being total mastectomy (conversion to total mastectomy after intraoperative frozen section biopsy is acceptable)
  • Personal history of ipsilateral breast cancer
  • Ductal carcinoma in situ component on CNB result
  • Lobular carcinoma (invasive, in situ)
  • Neoadjuvant chemotherapy
  • Lesion with microcalcification (microcalcification that is only contained inside the cancer mass is acceptable)
  • Multicentric tumor, however a daughter nodule within ≤ 1cm distance on breast MRI is acceptable
  • Non-mass enhancement extent wider than 1cm distance of main mass on breast MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975179


Contacts
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Contact: Byung Joo Chae 82 2 3410-3479 bj.chae@samsung.com

Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Byung Joo Chae, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03975179     History of Changes
Other Study ID Numbers: KC19EEDT0031
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Byung Joo Chae, Samsung Medical Center:
frozen section biopsy
resection margin
breast conserving surgery