Clinical trial · Observational
Patient Report Outcome-Reconstruction and Oncoplastic Cohort
Chinese Multicenter Prospective Registry of Breast Cancer Patient Reported Outcome -Reconstruction and Oncoplastic Cohort
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Available studies that focused on patient-reported outcomes (PROs) were mainly from one institution or of small sample size. The variations across hospitals and regions were not fully analyzed. A multicenter prospective patient report outcome-reconstruction and oncoplastic cohort (PRO-ROC) will be planned to assess the PROs for Chinese breast cancer patients who will undergo breast reconstruction or oncoplastic breast-conserving surgery (OBCS). The inclusion criteria are female breast cancer patients \>18 years old, who will undergo breast reconstruction (BR) or OBCS. This cohort will include at least 10000 patients (about 5000 patients who undergo BR, and 5000 patients who undergo OBCS). The exposures were the surgery types: BR and OBCS regardless of the techniques and materials they used. The primary endpoint will be PROs, which include BREAST-Q, quality of life (EORTC QLQ-C30), EORTC QLQ-BR23). This study follows the Helsinki Declaration and Chinese rules. All patients will be asked to to sign the informed consent and will be followed up 24 months after operations. All data will be collected using an app software.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Reconstruction | — | UNRESOLVED | — |
| Oncoplastic Breast-conserving Surgery | — | UNRESOLVED | — |
| Patient Reported Outcome Measures | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| breast reconstruction | Procedure | — | UNRESOLVED |
| oncoplastic breast-conserving surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- breast reconstruction
- interventionNames
- Procedure: breast reconstruction
- label
- oncoplastic breast-conserving surgery
- interventionNames
- Procedure: oncoplastic breast-conserving surgery
Primary outcomes (3)
- measure
- Change from baseline in BREAST-Q score
- timeFrame
- Change from baseline at 1 year and 2 years post-operatively.
- description
- The Breast-Q© is a patient reported outcome measure (PROM) for breast surgery that was rigorously developed to accurately measure patient reported satisfaction and quality of life (QOL). (http://www.mskcc.org/mskcc/shared/Breast-Q/index.html). The BREAST-Q was developed and validated with adherence to international guidelines. This PROM is composed of six scales that address: 1) psychosocial well-being, 2) physical well-being, 3) sexual well-being, 4) satisfaction with breasts, 5) satisfaction with outcome, and 6) satisfaction with care. Each module generates a Q-score on a 0-100 scale that can be used for quantitative analysis to enable statistical comparison of the pre- to the post-operative state.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Breast cancer patients; 2. Adult (\>18 years old); 3. Female; 4. Must undergo breast reconstruction or oncoplastic breast-conserving surgery; Exclusion Criteria: 1. Younger (\<18 years old); 2. Male; 3. Stage IV breast cancer patients; 4. Refuse to undergo breast reconstruction or oncoplastic breast-conserving surgery.
References
Publications (2)
- DERIVEDChi W, Zhang Q, Li L, Chen M, Xiu B, Yang B, Wu J. Immediate Breast Reconstruction After Neoadjuvant Chemotherapy: Factors Associated With Surgical Selection and Complications. Ann Plast Surg. 2023 Jul 1;91(1):48-54. doi: 10.1097/SAP.0000000000003574. Epub 2023 May 19. PMID 37216212
- DERIVEDLi L, Yang B, Li H, Yin J, Jin F, Han S, Liao N, Shi J, Ling R, Li Z, Ouyang L, Wang X, Fu P, Ouyang Z, Ma B, Wu X, Wang H, Liu J, Shao Z, Wu J. Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol. BMJ Open. 2019 Dec 15;9(12):e032945. doi: 10.1136/bmjopen-2019-032945. PMID 31843846