Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)
Recruiting · NCT06401304 · Observational (researchers observe without assigning treatment) · Lead sponsor: Uppsala University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
Where it is running
3 locations listed.
- Royal Marsden Hospital - London, United Kingdom
- Westmead Breast Cancer Institute - Sydney, Australia
- Uppsala University Hospital - Uppsala, Sweden