PARTial BREast RECONstruction With Chest Wall Perforator Flap
NCT ID: NCT06728527
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1001 participants
OBSERVATIONAL
2023-06-01
2026-05-31
Brief Summary
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Detailed Description
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A) Patient Demographics and Tumour characteristics
1. Patient demographics: age, body mass index (BMI), comorbidities
2. Preoperative tumour characteristics and location influencing surgical planning
B) Treatment characteristics
1. Surgical: operative data, including flap types and distribution
2. Oncological: systemic therapies (adjuvant and neoadjuvant), radiotherapy
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Delayed correction of breast deformity following previous BCS
* Each surgeon is to have performed a minimum of 10 CWPFs
* Each centre anticipates completing a minimum of 10/year
Exclusion Criteria
* Patients undergoing mastectomy +/- immediate breast reconstruction
18 Years
FEMALE
No
Sponsors
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Oxford University Hospitals NHS Trust
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Amit Agrawal
Consultant Oncoplastic Breast Surgeon
Principal Investigators
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Amit Agrawal
Role: PRINCIPAL_INVESTIGATOR
Cambridge University Hospitals NHS Trust
Locations
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Cambridge University Hospitals NHS Trust
Cambridge, Cambridgeshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Amit Agrawal, DM, FRCSsurg
Role: primary
References
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Agrawal A, Romics L, Thekkinkattil D, Soliman M, Kaushik M, Barmpounakis P, Mortimer C, Courtney CA, Goyal A, Garreffa E, Carmichael A, Lane RA, Rutherford C, Kim B, Achuthan R, Pitsinis V, Goh S, Ray B, Grover K, Vidya R, Murphy J; PartBreCon Collaborators. 'PartBreCon' study. A UK multicentre retrospective cohort study to assess outcomes following PARTial BREast reCONstruction with chest wall perforator flaps. Breast. 2023 Oct;71:82-88. doi: 10.1016/j.breast.2023.07.007. Epub 2023 Jul 17.
Garreffa E, Meattini I, Coles CE, Agrawal A. Use of tumour bed boost radiotherapy in volume replacement oncoplastic breast surgery: A systematic review. Crit Rev Oncol Hematol. 2023 Jun;186:103996. doi: 10.1016/j.critrevonc.2023.103996. Epub 2023 Apr 14.
Agrawal A. Oncoplastic breast surgery and radiotherapy-Adverse aesthetic outcomes, proposed classification of aesthetic components, and causality attribution. Breast J. 2019 Mar;25(2):207-218. doi: 10.1111/tbj.13193. Epub 2019 Feb 1.
Association of Breast Surgery A. NHSBSP and ABS Audit. Accessed 24.05.2020, https://associationofbreastsurgery.org.uk/professionals/audit/nhs-breast-screening-programme-audit/
Garreffa E, Hughes-Davies L, Russell S, Lightowlers S, Agrawal A. Definition of Tumor Bed Boost in Oncoplastic Breast Surgery: An Understanding and Approach. Clin Breast Cancer. 2020 Aug;20(4):e510-e515. doi: 10.1016/j.clbc.2020.03.003. Epub 2020 Mar 20.
Agrawal A, Mirshekar-Syahkal B. Use of combination of modules of BREAST-Q in partial breast reconstruction with lateral chest wall perforator flap. Eur J Surg Oncol. 2016;42(5):S39. doi:https://doi.org/10.1016/j.ejso.2016.02.155
Navin C, Agrawal A, Kolar KM. The use of latissimus dorsi miniflap for reconstruction following breast-conserving surgery: experience of a small breast unit in a district hospital. World J Surg. 2007 Jan;31(1):46-50. doi: 10.1007/s00268-006-0396-7.
Hamdi M, Van Landuyt K, Monstrey S, Blondeel P. Pedicled perforator flaps in breast reconstruction: a new concept. Br J Plast Surg. 2004 Sep;57(6):531-9. doi: 10.1016/j.bjps.2004.04.015.
Roy PG, Tenovici AA. Staged approach to partial breast reconstruction to avoid mastectomy in women with breast cancer. Gland Surg. 2017 Aug;6(4):336-342. doi: 10.21037/gs.2017.03.08.
Brouwers PJAM, van Werkhoven E, Bartelink H, Fourquet A, Lemanski C, van Loon J, Maduro JH, Russell NS, Scheijmans LJEE, Schinagl DAX, Westenberg AH, Poortmans P, Boersma LJ; Young Boost Trial research group. Predictors for poor cosmetic outcome in patients with early stage breast cancer treated with breast conserving therapy: Results of the Young boost trial. Radiother Oncol. 2018 Sep;128(3):434-441. doi: 10.1016/j.radonc.2018.06.020. Epub 2018 Jul 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Lead Site
Other Identifiers
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ID5342
Identifier Type: -
Identifier Source: org_study_id