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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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)
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Scientific title
Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery. A Multicentre, Cohort Study
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Secondary ID [1]
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UUBreast04
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Universal Trial Number (UTN)
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Trial acronym
OncoPROValue-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Breast Carcinoma in Situ
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Breast Cancer Invasive
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Breast Asymmetry
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Condition category
Condition code
Cancer
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Breast
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Cancer
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Cervical (cervix)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Avoidance of mastectomy
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Assessment method [1]
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Percenteage of patients not amenable to standard wide local excision following a standardized assessment, that are operated with oncoplastic breast conservation resulting in negative margins and avoid mastectomy.
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Timepoint [1]
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3 months
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Primary outcome [2]
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Re-excision rates
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Assessment method [2]
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Percenteage of patients not amenable to standard wide local excision following a standardized assessment, that undergo breast conservation, but require re-excision of margins without conversion to mastectomy as a final result.
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Timepoint [2]
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3 months
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Primary outcome [3]
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Patient reported outcomes, European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30)
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Assessment method [3]
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The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) is a validated 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients. It assesses both quality of life domains and symptom domains in a scale score ranging from 0 to 100. For the quality of life domains, higher scores denote higher satisfaction or higher quality of life. For symptom scales, higher score denotes more severe symptoms. In the Summary Score of the Questionnaire, higher values denote higher quality of life
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Timepoint [3]
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Baseline, postoperative (6, 12, 24 months)
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Primary outcome [4]
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Patient reported outcomes, BreastQ module for Satisfaction with Breasts
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Assessment method [4]
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The BREAST-Q questionnaire is developed especially for breast cancer patients undergoing breast surgery. Independent modules are available for the different surgical interventions (e.g., mastectomy, reconstruction, augmentation). The BREAST-Q questionnaire has been validated and serves as of a standardized measurement instrument. The Satisfaction with Breasts module is summarized in a score ranging from 0 to 100, with higher scores denoting higher satisfaction
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Timepoint [4]
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Baseline, postoperative (6, 12, 24 months)
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Primary outcome [5]
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Patient reported outcomes, BreastQ module for Physical Wellbeing: Chest
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Assessment method [5]
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The BREAST-Q questionnaire is developed especially for breast cancer patients undergoing breast surgery. Independent modules are available for the different surgical interventions (e.g., mastectomy, reconstruction, augmentation). The BREAST-Q questionnaire has been validated and serves as of a standardized measurement instrument. The Physical Wellbeing: Chest module is summarized in a score ranging from 0 to 100, with higher scores denoting higher wellbeing
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Timepoint [5]
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Baseline, postoperative (6, 12, 24 months)
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Secondary outcome [1]
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Postoperative Complications
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Assessment method [1]
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Postoperative complications, reported descriptively, per the modified Clavien Dindo classification and the Comprehensive Complication Index 2.0 (CCI 2.0)
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Timepoint [1]
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6 weeks or up to 3 months if no other adjuvant oncologic treatment has been employed
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Secondary outcome [2]
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Operative time
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Assessment method [2]
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Operative time in minutes
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Timepoint [2]
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At surgery
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Secondary outcome [3]
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Length of stay
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Assessment method [3]
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Number of days of inpatient care
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Timepoint [3]
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Perioperative
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Secondary outcome [4]
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Profile of mastectomy candidates
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Assessment method [4]
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Characteristics of patients that require mastectomy per surgeon assessment
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Timepoint [4]
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Preoperative
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Secondary outcome [5]
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Procedure-related costs
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Assessment method [5]
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Costs related with each surgical procedure
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Timepoint [5]
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Postoperative
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Secondary outcome [6]
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Local Recurrence Free Survival
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Assessment method [6]
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Time from Surgery to ipsilateral local recurrence (in situ or invasive)
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Timepoint [6]
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Up to 10 years
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Secondary outcome [7]
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Locoregional Recurrence Free Survival
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Assessment method [7]
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Time from Surgery to ipsilateral locoregional recurrence (in situ or invasive)
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Timepoint [7]
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Up to 10 years
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Secondary outcome [8]
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Disease Free Survival
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Assessment method [8]
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Time from Surgery to any recurrence
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Timepoint [8]
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Up to 10 years
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Secondary outcome [9]
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Breast Cancer Specific Survival
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Assessment method [9]
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Time from surgery to breast cancer related death
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Timepoint [9]
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Up to 10 years
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Secondary outcome [10]
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Overall Survival
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Assessment method [10]
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Time from surgery to death from any cause
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Timepoint [10]
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Up to 10 years
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/12/2032
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Actual
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Sample size
Target
1200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Westmead Breast Cancer Institute - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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Sweden
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State/province [1]
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Uppsala
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Country [2]
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United Kingdom
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State/province [2]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
Uppsala University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Uppsala University Hospital
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Royal Marsden NHS Foundation Trust
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Westmead Breast Cancer Institute, Sydney University, Sydney, Australia
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Breast Unit, University Campus Biomedico, Rome, Italy
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT06401304
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Andreas Karakatsanis, MD, PhD
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Address
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Uppsala University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Andreas U Karakatsanis, MD, PhD
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Address
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Country
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Phone
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+46765864826
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06401304
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