Recruiting

Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)

The study aspires to provide outcomes on surgery, quality of life and time-to-event outcomes following the development and validation of a standardised surgical assessment tool in a shared decision-making framework for patients with pre-invasive or invasive breast cancer with breast conservation.

ClinicalTrials.gov IDNCT06401304

PhaseNot Applicable

Enrollment1200

SponsorUppsala University

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer, Breast Carcinoma in Situ, Breast Cancer Invasive, Breast Asymmetry

About this study

Primary outcomes

Avoidance of mastectomy (3 months)
Re-excision rates (3 months)
Patient reported outcomes, European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) (Baseline, postoperative (6, 12, 24 months))
Patient reported outcomes, BreastQ module for Satisfaction with Breasts (Baseline, postoperative (6, 12, 24 months))
Patient reported outcomes, BreastQ module for Physical Wellbeing: Chest (Baseline, postoperative (6, 12, 24 months))

Eligibility information

Inclusion Criteria: 1. Female aged above 18 years. 2. Signed and dated written informed consent before the start of specific protocol procedures; oral consent for the participants of the quality control retrospective cohort study before accepting to partake a telephone interview. 3. Patients with invasive breast cancer (IBC) or ductal cancer in situ (DCIS) or unclear lesions mandating surgical excision or benign lesions amenable for surgical resection with BCS. 4. ECOG performance status 0-2. Exclusion Criteria 1. Life expectancy of less than 6 months 2. Non candidate for breast conservation 3. Inability to understand given information and give informed consent or undergo study procedures

Study locations

Westmead Breast Cancer Institute, Sydney, Australia
Uppsala University Hospital, Uppsala, 75185 Sweden
Royal Marsden Hospital, London, United Kingdom

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.