MedTrace Logo

Patient Report Outcome and Oncological Safety -Oncoplastic and Conventional BCS Cohort

NCT05054777 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2021-09-23

No results posted yet for this study

Summary

Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic BCS could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as conventional BCS does. However, these studies that focused on patient-reported outcomes and oncological safety 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 (PROs) and oncological safety will be planned to assess the PROs and safety for Chinese breast cancer patients who will undergo oncoplastic and conventional breast-conserving surgery (OBCS). This study follows the Helsinki Declaration and Chinese rules. All patients will be asked to sign the informed consent and will be followed up 24 months after operations. All data will be collected.

Conditions

  • Breast Cancer Female
  • Patient Reported Outcome
  • Oncological Safety
  • Breast-conserving Surgery

Interventions

PROCEDURE

oncoplastic breast-conserving surgery

The patients received oncoplastic breast-conserving surgery, including volume displacement or volume replacement techniques

PROCEDURE

conventional breast-conserving surgery

conventional breast-conserving surgery without any oncoplastic operations

Sponsors & Collaborators

  • Shandong Cancer Hospital and Institute

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-12-30
Completion
2024-12-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05054777 on ClinicalTrials.gov