Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUppsala University
About this trial
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.
Eligibility criteria
Qualifiers
Female aged above 18 years.
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.
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.
ECOG performance status 0-2.
Disqualifiers
Life expectancy of less than 6 months
Non candidate for breast conservation
Inability to understand given information and give informed consent or undergo study procedures
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Uppsala University
Lead sponsor
Uppsala University Hospital
Collaborator
Royal Marsden NHS Foundation Trust
Collaborator
University of Sydney
Collaborator
Breast Unit, University Campus Biomedico, Rome, Italy
Collaborator
Source ClinicalTrials.gov