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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06401304




Registration number
NCT06401304
Ethics application status
Date submitted
27/04/2024
Date registered
6/05/2024
Date last updated
6/05/2024

Titles & IDs
Public title
Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)
Scientific title
Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery. A Multicentre, Cohort Study
Secondary ID [1] 0 0
UUBreast04
Universal Trial Number (UTN)
Trial acronym
OncoPROValue-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Breast Carcinoma in Situ 0 0
Breast Cancer Invasive 0 0
Breast Asymmetry 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Avoidance of mastectomy
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
Re-excision rates
Timepoint [2] 0 0
3 months
Primary outcome [3] 0 0
Patient reported outcomes, European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30)
Timepoint [3] 0 0
Baseline, postoperative (6, 12, 24 months)
Primary outcome [4] 0 0
Patient reported outcomes, BreastQ module for Satisfaction with Breasts
Timepoint [4] 0 0
Baseline, postoperative (6, 12, 24 months)
Primary outcome [5] 0 0
Patient reported outcomes, BreastQ module for Physical Wellbeing: Chest
Timepoint [5] 0 0
Baseline, postoperative (6, 12, 24 months)
Secondary outcome [1] 0 0
Postoperative Complications
Timepoint [1] 0 0
6 weeks or up to 3 months if no other adjuvant oncologic treatment has been employed
Secondary outcome [2] 0 0
Operative time
Timepoint [2] 0 0
At surgery
Secondary outcome [3] 0 0
Length of stay
Timepoint [3] 0 0
Perioperative
Secondary outcome [4] 0 0
Profile of mastectomy candidates
Timepoint [4] 0 0
Preoperative
Secondary outcome [5] 0 0
Procedure-related costs
Timepoint [5] 0 0
Postoperative
Secondary outcome [6] 0 0
Local Recurrence Free Survival
Timepoint [6] 0 0
Up to 10 years
Secondary outcome [7] 0 0
Locoregional Recurrence Free Survival
Timepoint [7] 0 0
Up to 10 years
Secondary outcome [8] 0 0
Disease Free Survival
Timepoint [8] 0 0
Up to 10 years
Secondary outcome [9] 0 0
Breast Cancer Specific Survival
Timepoint [9] 0 0
Up to 10 years
Secondary outcome [10] 0 0
Overall Survival
Timepoint [10] 0 0
Up to 10 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2032
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Westmead Breast Cancer Institute - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Sweden
State/province [1] 0 0
Uppsala
Country [2] 0 0
United Kingdom
State/province [2] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Uppsala University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Uppsala University Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Marsden NHS Foundation Trust
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Westmead Breast Cancer Institute, Sydney University, Sydney, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Breast Unit, University Campus Biomedico, Rome, Italy
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06401304
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Karakatsanis, MD, PhD
Address 0 0
Uppsala University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Andreas U Karakatsanis, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+46765864826
Fax 0 0
Email 0 0
andreas.karakatsanis@uu.se
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06401304