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NCT05054777

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

Status unknown Last updated 23 September 2021
What this trial tests

trial testing oncoplastic breast-conserving surgery in Patient Reported Outcome in 5,000 participants. Status unknown.

Timeline
1 October 2021
Primary endpoint
30 December 2024
30 December 2024

Quick facts

Lead sponsorShandong Cancer Hospital and Institute
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment5,000
Start date1 October 2021
Primary completion30 December 2024
Estimated completion30 December 2024

Drugs / interventions tested

Conditions studied

Sponsor

Shandong Cancer Hospital and Institute

Who can join

Adults 18 to 80, female only, with Patient Reported Outcome or Oncological Safety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of oncoplastic breast-conserving surgery

Trials testing the same drug.

Other Shandong Cancer Hospital and Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05054777.

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