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临床试验/CTRI/2025/05/087008
CTRI/2025/05/087008尚未招募不适用

A multi-centre PROspective study,including PROMS of PARTial BREast ReCONstruction with chest wallperforator flap

Not applicable1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年5月30日最近更新:
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试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
试验地点
1
主要终点
2. Preoperative tumour characteristics and location influencing surgical planning
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Summary of PartBreCon-Pro Study Protocol

  • Study Type: Multicentre prospective cohort study on partial breast reconstruction using chest wall perforator flaps (CWPF).
  • Objective: Evaluate clinical and patient-reported outcomes post-breast-conserving surgery.
  • Duration: 36 months (June 2023 - May 2026).
  • Data Collection: Includes surgical outcomes, oncological treatment, and patient-reported outcomes (PROMs).
  • Significance: Aims to establish performance standards and improve patient care in breast cancer treatment.
  • Contact: partbrecon.pros@gmail.com

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)（—）
性别
Female

入选标准

  • •Patients undergoing partial breast reconstruction using CWPF for primary breast cancer
  • •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.

排除标准

  • •Patients undergoing volume displacement BCS
  • •Patients undergoing mastectomy +/- immediate breast reconstruction.

结局指标

主要结局

2. Preoperative tumour characteristics and location influencing surgical planning

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

B) Treatment characteristics

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

1. Patient demographics: age, body mass index (BMI), comorbidities

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

3. Post-radiotherapy (6 months)

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

A) Patient Demographics and Tumour characteristics

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

1. Surgical: operative data, including flap types and distribution

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

2. Oncological: systemic therapies (adjuvant and neoadjuvant), radiotherapy

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

2. Surveillance

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

3. Oncological: Recurrence and Mortality

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

E) Patient-reported outcomes

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

1. Pre-operative

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

2. Post-operative (pre-radiotherapy)

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

C) Primary outcome: Surgical

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

2. Oncological clearance: Re-excision rates, conversion to mastectomy

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

D) Secondary outcomes

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

1. Revisional surgery

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

1. Complications

时间窗: 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 | C) Primary outcome: Surgical | 1. Complications | 2. Oncological clearance: Re-excision rates, conversion to mastectomy | D) Secondary outcomes | 1. Revisional surgery | 2. Surveillance | 3. Oncological: Recurrence and Mortality | E) Patient-reported outcomes | 1. Pre-operative | 2. Post-operative (pre-radiotherapy) | 3. Post-radiotherapy (6 months)

次要结局

  • 1. Revisional surgery(2. Surveillance)

研究者

申办方类型
Other [Not applicable]

研究点 (1)

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