Breast CancerNCT00677430
Quantitative Analysis of Outcomes in Breast Reconstruction
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Questionnaire and Digital Imaging
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to 9 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Study participants with breast cancer that have had or are about to have breast reconstructive surgery.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Multimodality Anthropometric Analysis for Quantitative Assessment of Outcomes in Breast Reconstructive Surgery
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.
Read the detailed description
If you agree to take part in this study, you will be asked to fill out a brief questionnaire packet. This packet contains questions about how you feel about your appearance and your overall well-being. You will be asked to have photographs of your breast(s) taken with two different types of digital cameras (2D and 3D). These are the same type of photographs routinely taken for all patients having breast reconstructive surgery. The photographs and measurements will be taken during your routine clinic visit. You will not be identifiable in the photographs.
The photographs will be used to develop automated methods for evaluating the appearance and shape of the breasts.
You may be asked to complete additional follow-up visits for this study. These visits would take place at a regularly-scheduled clinic visit that takes place just before a surgical procedure is planned. At these visits you would be asked to fill out another questionnaire packet and to allow the research the research staff to repeat the photographs. The number of follow-up visits needed would depend on your individual treatment plan. A final study visit would take place once you feel you are finished with your breast reconstructive process. At this point, your participation in the study would be completed. Breast reconstruction is different for each patient. The length of time of the reconstructive process depends on the procedure(s) that you and your surgeon have agreed upon. These options will be discussed at your regularly scheduled clinic appointments.
This is an investigational study. A total of up to 300 patients will take part in this study. All will be enrolled at UTMDACC.
- Conditions
- Breast Cancer
- Being tested
- Questionnaire, Digital Imaging
- Keywords
- Breast Cancer, Breast Reconstruction, Digital Imaging, Questionnaire, Survey
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
A brief questionnaire packet will be completed.
Digital ImagingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Questionnaire; Procedure: Digital Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate accuracy of digital image-processing techniques used to provide the physical dimensions of human breasts.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startMay 2008
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory P. Reece, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677430
- Sponsor's protocol ID
- 2004-0899
- Other IDs
- RSGPB-09-157-01-CPPB
- Status last verified
- Apr 2021
- First submitted
- 9 May 2008
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Anthropometric Analysis for Quantitative Assessment of Outcomes in Breast Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT00677430
- Acronym / sponsor ID
- 2004-0899
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Breast Reconstruction, Digital Imaging, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2008 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 14 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
If you agree to take part in this study, you will be asked to fill out a brief questionnaire packet. This packet contains questions about how you feel about your appearance and your overall well-being. You will be asked to have photographs of your breast(s) taken with two different types of digital cameras (2D and 3D). These are the same type of photographs routinely taken for all patients having breast reconstructive surgery. The photographs and measurements will be taken during your routine clinic visit. You will not be identifiable in the photographs.
The photographs will be used to develop automated methods for evaluating the appearance and shape of the breasts.
You may be asked to complete additional follow-up visits for this study. These visits would take place at a regularly-scheduled clinic visit that takes place just before a surgical procedure is planned. At these visits you would be asked to fill out another questionnaire packet and to allow the research the research staff to repeat the photographs. The number of follow-up visits needed would depend on your individual treatment plan. A final study visit would take place once you feel you are finished with your breast reconstructive process. At this point, your participation in the study would be completed. Breast reconstruction is different for each patient. The length of time of the reconstructive process depends on the procedure(s) that you and your surgeon have agreed upon. These options will be discussed at your regularly scheduled clinic appointments.
This is an investigational study. A total of up to 300 patients will take part in this study. All will be enrolled at UTMDACC.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire + Digital Imaging | – | Behavioral: Questionnaire, Procedure: Digital ImagingA 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants with breast cancer that have had or are about to have breast reconstructive surgery.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyA brief questionnaire packet will be completed. | Behavioural | Questionnaire + Digital Imaging |
| Digital ImagingPhotographs 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. | Procedure or surgery | Questionnaire + Digital Imaging |
Primary outcome
Evaluate accuracy of digital image-processing techniques used to provide the physical dimensions of human breasts.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory P. Reece, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate accuracy of digital image-processing techniques used to provide the physical dimensions of human breasts. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.