Breast CancerNCT01679223
Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12
An observational study of Breast Cancer, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
The purpose of this study is to measure the level of AlloMax™ incorporation (cellular infiltration, collagen production, and neovascularization) in human breast reconstruction. The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast capsule at the 3-4 month time point. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Nov 2018
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (18 - 70 yrs) scheduled for immediate two stage breast reconstruction with AlloMaxTM are potential subjects for this study
Who may be able to join
- Adult patients (18 - 70 yrs) who require reconstructive breast surgery with AlloMaxTM implants and agree to participate will be included in this study.
Who cannot join
- Patients who do not agree to be included in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Nevada School of Medicine
Las Vegas, Nevada, 89102-2227
Sherree Mounts, LPN, 702-671-5117, smounts@medicine.nevada.edu
Kayvan Taghipour-Khiabani, M.D.
About this study
Official title: Objective Evaluation of Collagen Deposition in AlloMaxTM Acellular Dermal Matrix in Breast Reconstruction Version 8-15-12
The purpose of this study is to measure the level of AlloMax™ incorporation (cellular infiltration, collagen production, and neovascularization) in human breast reconstruction. The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast capsule at the 3-4 month time point.
- Conditions
- Breast Cancer
- Keywords
- Breast reconstruction, Hydroxyproline concentration, neoangiogenesis, collagen deposition
- Medical subject headings
- Breast Neoplasms, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| <40 years | subjects aged less than 40 years | |
| 40-60 years | subjects aged 40-60years | |
| > 60 years | subjects aged greater than 60 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydroxyproline Concentration
Hydroxyproline will be measured in the AlloMaxTM and adjacent capsule.
Measured: 3-4 months
Neoangiogenesis
Measure new blood vessels in AlloMaxTM and adjacent capsule
Measured: 3-4 months
Collagen I and III
Measure collagen I and III in AlloMaxTM and adjacent capsule
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startFeb 2014
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
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.
- 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kayvan Taghipour-Khiabani, M.D., University of Nevada, Las Vegas
- Investigators
- Kayvan Taghipour-Khiabani, M.D., Principal investigator, University of Nevada School of MedicineWilliam A Zamboni, M.D., Study chair, University of Nevada School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679223
- Sponsor's protocol ID
- 081512
- Status last verified
- Jan 2015
- First submitted
- 31 Aug 2012
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Evaluation of Collagen Deposition in AlloMaxTM Acellular Dermal Matrix in Breast Reconstruction Version 8-15-12
- ClinicalTrials.gov ID
- NCT01679223
- Acronym / sponsor ID
- 081512
- Conditions
- Breast Cancer
- Keywords
- Breast reconstruction, Hydroxyproline concentration, neoangiogenesis, collagen deposition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 5 Sep 2012 (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 purpose of this study is to measure the level of AlloMax™ incorporation (cellular infiltration, collagen production, and neovascularization) in human breast reconstruction. The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast capsule at the 3-4 month time point.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| <40 years | – | –subjects aged less than 40 years |
| 40-60 years | – | –subjects aged 40-60years |
| > 60 years | – | –subjects aged greater than 60 years |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (18 - 70 yrs) scheduled for immediate two stage breast reconstruction with AlloMaxTM are potential subjects for this study
Key inclusion criteria (1 listed)
- Adult patients (18 - 70 yrs) who require reconstructive breast surgery with AlloMaxTM implants and agree to participate will be included in this study.
Key exclusion criteria (1 listed)
- Patients who do not agree to be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hydroxyproline Concentration
Time frame: 3-4 months
Hydroxyproline will be measured in the AlloMaxTM and adjacent capsule.
Neoangiogenesis
Time frame: 3-4 months
Measure new blood vessels in AlloMaxTM and adjacent capsule
Collagen I and III
Time frame: 3-4 months
Measure collagen I and III in AlloMaxTM and adjacent capsule
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
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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.
Kayvan Taghipour-Khiabani, M.D. principal investigator
University of Nevada School of Medicine
William A Zamboni, M.D. study chair
University of Nevada School of Medicine
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 University of Nevada, Las Vegas 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jan 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kayvan Taghipour-Khiabani, M.D. (702-671-2267, kkhiabani@medicine.nevada.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydroxyproline Concentration (time frame: 3-4 months). The study lists 3 primary outcomes in all. 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 9 Jan 2015.