NCT02341820

Brief Summary

This project which is fully funded by the European Union FP7 Program is designed to pull together all the information we obtain from scans and x-rays to design a personalised 3-D digital model of each patient, their anatomy and disease. We can then use this as follows: as (i) an aid to surgical planning to enable objective clinical decision making (ii) a decision support tool to communicate the available treatment options to the patient and facilitate shared decision making and provision of personalised care and (iii) to enable standardised objective evaluation of the aesthetic outcome of the treatment procedures. This study aims to demonstrate the ability of the Virtual Physiological Human concept to empower breast cancer patients and assess the impact on their care and quality of life.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 17, 2017

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

January 13, 2015

Last Update Submit

March 16, 2017

Conditions

Breast Neoplasms

Keywords

breast cancerbreast conserving surgerycosmesis

Outcome Measures

Primary Outcomes (1)

  • Creation of a reliable demonstrator.

    The primary objective of the study is to create a reliable demonstrator (software) by integrating models of surgical techniques and treatment schemes, clinical patient data, multi-modal imaging and individualised models of patient anatomy. The demonstrator will be used as an aid to objective surgical planning, via simulation of the cosmetic effects of breast conserving surgery, as a decision support tool to communicate the available options to the patient and to enable standardised evaluation of the procedure.

    One year

Secondary Outcomes (1)

  • Assess health-related quality of life.

    One year

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who are scheduled to undergo breast conserving surgery for early breast cancer.

You may qualify if:

  • Women undergoing breast conserving surgery for early breast cancer.
  • Willing and able to return for a one-year visit.
  • Written informed consent obtained.

You may not qualify if:

  • Unable to provide written informed consent.
  • Younger than 18 years.
  • Benign breast disease.
  • Women undergoing mastectomy.
  • Unable to have an MRI scan (e.g. claustrophobia, too large, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Leiden University Medical Center (LUMC)

Leiden, Netherlands

Location

Champalimaud Cancer Center

Lisbon, Portugal

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mo Keshtgar

    Royal Free London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 19, 2015

Study Start

April 1, 2014

Primary Completion

February 1, 2016

Study Completion

December 1, 2016

Last Updated

March 17, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

All requests for data sharing will adhere to the UCL Surgical \& Interventional Trials Unit (SITU) data sharing agreement policy. UCL Medical School is supportive of data sharing and will endeavour to assist in requests for data sharing. These data will be held at UCL on secure servers and will not be released to any third parties until the final study report has been published. All requests for access to the data will be formally requested through the use of a SITU data request form which will state the purpose, analysis and publication plans together with the named collaborators. All requests are dealt with on a case by case basis. All requests will be logged and those successful will have a data transfer agreement which will specify appropriate acknowledgement of the Royal Free Hospital, the sponsor, and funders.

Locations

NL(1)PT(1)GB(1)