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Multi-focal Breast Cancers(MFBC) still have undiscoverable Clinical Significance reflecting on a debatable surgical decision for this Category of breast cancer. A prospective study was conducted using certain surgical technique as a surgical treatment for female patients with operable breast cancer managed at the Surgical Oncology Unit, Alexandria University from May. 2017 to May2018 and will be followed for 3 Years.Analysis will be done to settle a paradigm for surgical management of Multi-focal Breast Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oncoplastic breast surgery | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oncoplastic breast surgery | Procedure | oncoplastic breast surgery with level 1 or 2 according to the case using intra operative frozen section to assess the margin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of the Tumor | assessment of the occurrence of local or distant recurrence through:
| a median of 30 months post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic Result | assessment of breast cosmesis after oncoplastic surgical intervention.Evaluation is based on 5 criteria, namely: breast symmetry, glandular tissue defects, nipple and areola reconstruction, scar quality and/or retraction, and the resultant breast shape. each criteria will be evaluated either satisfactory or not,satisfactory evaluation will represent 1 point. unsatisfactory will represent 0 point excellent result is equal or more than 4 points good result is equal to 3 points fair result is equal to 2 points bad result is equal to 1 point or less |
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Inclusion Criteria:
Exclusion Criteria:
all operable female patients affected with multifocal breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed T. Awad, MD | professor of surgical oncology,Alexandria university | Study Director |
| Mostafa M. Elsayed, Msc | Surgical oncology registrar,Alexandria university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine ,Alexandria university | Alexandria | 21500 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19082705 | Result | Yerushalmi R, Kennecke H, Woods R, Olivotto IA, Speers C, Gelmon KA. Does multicentric/multifocal breast cancer differ from unifocal breast cancer? An analysis of survival and contralateral breast cancer incidence. Breast Cancer Res Treat. 2009 Sep;117(2):365-70. doi: 10.1007/s10549-008-0265-1. Epub 2008 Dec 11. | |
| 18330695 | Result |
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IPD will be available that underlie results in a publication
will be available for 1 year after publication
individual participant data will be available to every researcher in field of multi -focal breast cancer, the candidate should have an accepted protocol from the ethical committee of the organization. contacting the main investigator will be method to review the request
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| ID | Title | Description |
|---|---|---|
| FG000 | Multifocal Breast Cancer Patients Treated Surgically by MRM | multifocal breast cancer patients involved in the study will be randomized to be treated either by oncoplastic breast conserving surgery or modified radical mastectomy(MRM) |
| FG001 | Multifocal Breast Cancer Patients Treated Surgically by OPS | multifocal breast cancer patients involved in the study randomized in the setting of receiving surgical treatment either modified radical mastectomy (MRM) or oncoplastic breast surgery(OPS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Multifocal Breast Cancer Patients Treated Surgically by MRM | multifocal breast cancer patients involved in the study will be randomized to be treated either by oncoplastic breast conserving surgery or modified radical mastectomy(MRM) |
| BG001 | Multifocal Breast Cancer Patients Treated Surgically by OPS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age in years < 40 40- 50- 60+ |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrence of the Tumor | assessment of the occurrence of local or distant recurrence through:
| Posted | Count of Participants | Participants | a median of 30 months post operative |
|
through 24 months post operative
Early complications
Late complications
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multifocal Breast Cancer Patients Treated Surgically by MRM | multifocal breast cancer patient treated by modified radical mastectomy(MRM) 66 patients Early complications Haematoma 2 patients out of 56 Seroma 16 patients out of 56 Skin or flap necrosis 5 patients out of 56 Abcess 3 patients out of 56 Late complications Scar fibrosis 2 patients out of 56 keloid 1 patients out of 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Surgical and medical procedures | Systematic Assessment | Early post operative complication |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR. mostafa elsayed | Alexandria university | 560566541 | +966 | m_elsayed2009@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 1, 2018 | Mar 29, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2019 | Jan 16, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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All operable(don't require neoadjuvant therapy or inflammatory carcinoma) female patients diagnosed as multifocal breast cancer will receive oncoplastic breast surgery as a surgical treatment.
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| a median of 30 months post operative |
| Gentilini O, Botteri E, Rotmensz N, Da Lima L, Caliskan M, Garcia-Etienne CA, Sosnovskikh I, Intra M, Mazzarol G, Musmeci S, Veronesi P, Galimberti V, Luini A, Viale G, Goldhirsch A, Veronesi U. Conservative surgery in patients with multifocal/multicentric breast cancer. Breast Cancer Res Treat. 2009 Feb;113(3):577-83. doi: 10.1007/s10549-008-9959-7. Epub 2008 Mar 11. |
multifocal breast cancer patients involved in the study randomized in the setting of receiving surgical treatment either modified radical mastectomy (MRM) or oncoplastic breast surgery(OPS) |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| tumor size | T(TUMOR SIZE) T1 <2 cm T2 (2-5 cm) T3 > 5 cm T4 tumor attached to the skin | Count of Participants | Participants |
|
|
|
| Secondary | Cosmetic Result | assessment of breast cosmesis after oncoplastic surgical intervention.Evaluation is based on 5 criteria, namely: breast symmetry, glandular tissue defects, nipple and areola reconstruction, scar quality and/or retraction, and the resultant breast shape. each criteria will be evaluated either satisfactory or not,satisfactory evaluation will represent 1 point. unsatisfactory will represent 0 point excellent result is equal or more than 4 points good result is equal to 3 points fair result is equal to 2 points bad result is equal to 1 point or less | overall number of participants subjected to oncoplastic breast surgery is 58 subdivided to categories according to the oncoplastic technique used, totally 58 patients | Posted | Count of Participants | Participants | a median of 30 months post operative |
|
|
|
| 0 |
| 56 |
| 29 |
| 56 |
| 0 |
| 56 |
| EG001 | Multifocal Breast Cancer Patients Treated Surgically by OPS | multifocal breast cancer patients treated by oncoplastic breast surgery(OPS) 58 patients Early complications Haematoma 2 patients out of 58 Seroma 10 patients out of 58 Abcess 4 patients out of 58 Skin or NAC necrosis 2 patients out of 58 Late complications Scar fibrosis 3 patients out of 58 keloid 2 patients out of 58 steatonecrosis 5 patients out of 58 | 0 | 58 | 28 | 58 | 0 | 58 |
|
| Seroma | Surgical and medical procedures | Systematic Assessment | Early post operative complications |
|
| skin necrosis | Surgical and medical procedures | Systematic Assessment | Early post operative complications |
|
| abcess | Surgical and medical procedures | Systematic Assessment | early post operative |
|
| Scar fibrosis | Surgical and medical procedures | Systematic Assessment | Late post operative complications |
|
| keloid | Surgical and medical procedures | Systematic Assessment | late post operative complications |
|
| steatonecrosis | Surgical and medical procedures | Systematic Assessment | late post operative complications |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| round block |
|
|
| parallelogram mastopxy |
|
|
| V theraputic mammoplasty |
|
|
| Latissimus Dorsi flap |
|
|
| J theraputic mammoplasty |
|
|
| grisotti flap |
|
|
| reduction therapeutic mammoplasty |
|
|