Quantitative Analysis of Outcomes in Breast Reconstruction
Multimodality Anthropometric Analysis for Quantitative Assessment of Outcomes in Breast Reconstructive Surgery
2 other identifiers
observational
224
1 country
1
Brief Summary
The first objective of this study is to assess the accuracy of digital image-processing techniques to provide measurements of human breast physical dimensions. The ultimate usefulness of these techniques is to develop quantitative outcome measures of the visual appearance of breast after local treatments for breast cancer. These measures will be used to improve clinical outcomes from multimodality therapy that includes surgery and radiotherapy and form the basis for the future development of patient decision making aids. The second objective is to evaluate the relationship between patient reported body image outcomes and measurement of human breast physical dimensions for patients with breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 9, 2008
CompletedFirst Posted
Study publicly available on registry
May 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2021
CompletedApril 14, 2021
April 1, 2021
12.9 years
May 9, 2008
April 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate accuracy of digital image-processing techniques used to provide the physical dimensions of human breasts.
2 years
Study Arms (1)
Questionnaire + Digital Imaging
A brief questionnaire packet will be completed. Photographs of the breast(s) will be taken with two different types of digital cameras (2D and 3D). The photos will be used to develop automated methods for evaluating the appearance and shape of the breasts.
Interventions
A brief questionnaire packet will be completed.
Photographs of the breast(s) will be taken with two different types of digital cameras (2D and 3D). The photos will be used to develop automated methods for evaluating the appearance and shape of the breasts.
Eligibility Criteria
Study participants with breast cancer that have had or are about to have breast reconstructive surgery.
You may qualify if:
- Female
- Age greater than 21 years old.
- Candidate who has had or is planning to have breast reconstructive surgery and has at least one breast mound.
- Willing to participate in the study and able to complete informed consent.
- Proficient at reading and speaking English.
You may not qualify if:
- Women who have undergone previous bilateral mastectomy without reconstruction.
- Women who are unable to stand unassisted for 2 minutes.
- Diagnosis of serious mental illness (e.g. schizophrenia) or cognitive impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory P. Reece, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2008
First Posted
May 14, 2008
Study Start
May 1, 2008
Primary Completion
April 9, 2021
Study Completion
April 9, 2021
Last Updated
April 14, 2021
Record last verified: 2021-04