Breast CancerNCT00897468
Developing Mouse Models of Breast Cancer Using Tissue Samples From Women With Breast Cancer
An observational study of Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Changing the genes in laboratory mice to create a living model of human breast cancer may help doctors learn more about breast cancer. PURPOSE: This research study is developing mouse models of breast cancer using tissue samples that were previously collected from women with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- laboratory biomarker analysis and medical chart review
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to May 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: breast cancer patients
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Any stage of disease
- Primary or metastatic disease
- Human breast tumor tissues available after the diagnoses have been made
- Enrolled on the ongoing Breast Tissue Repository trial VU-VICC-BRE-03103
- Have consented to the use of their tissues for research purpose
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Developing In-Vivo Models of Human Breast Cancer
RATIONALE: Changing the genes in laboratory mice to create a living model of human breast cancer may help doctors learn more about breast cancer.
PURPOSE: This research study is developing mouse models of breast cancer using tissue samples that were previously collected from women with breast cancer.
Read the detailed description
OBJECTIVES:
- To develop new in vivo models of human breast cancer.
- To correlate response in this model to actual treatment outcome in patients, if the in vivo model is proven feasible.
OUTLINE: Previously collected breast tumor fragments are implanted into the renal capsule site of SCID mouse hosts (mouse with severe combined immune deficiency) to establish metastatic spread patterns, and both histologic and molecular tumor characteristics.
Patients' medical charts are reviewed to obtain relevant information, including general demographics, smoking and alcohol use, as well as outcome data such as survival and response to treatment.
- Conditions
- Breast Cancer
- Being tested
- laboratory biomarker analysis, medical chart review
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Tissue samples will either be collected at the time of medically indicated surgical procedures or through research core biopsies. A sample of urine will also be obtained. Blood will be collected via venipuncture and lymphocytes (mononuclear cells) separated and processed as a source of normal DNA and normal cells.
medical chart reviewOther
patient chart review will occur in conjunction with patient data collection for final analyses.
| Study group | Role | What they receive |
|---|---|---|
| breast cancer patients | Not described Receives: Other: laboratory biomarker analysis; Other: medical chart review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of new in vivo models of human breast cancer
Measured: 1 year
Correlation of response in this model to actual treatment outcome in patients, if the in vivo model proven feasible
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startFeb 2007
- Primary completionMay 2018
- Study completionMay 2018
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
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- A. Bapsi Chakravarthy, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897468
- Sponsor's protocol ID
- VICC BRE 0704
- Other IDs
- P30CA068485, VU-VICC-BRE-0704
- Status last verified
- May 2018
- First submitted
- 9 May 2009
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing In-Vivo Models of Human Breast Cancer
- ClinicalTrials.gov ID
- NCT00897468
- Acronym / sponsor ID
- VICC BRE 0704
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2007
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 12 May 2009 (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.
RATIONALE: Changing the genes in laboratory mice to create a living model of human breast cancer may help doctors learn more about breast cancer.
PURPOSE: This research study is developing mouse models of breast cancer using tissue samples that were previously collected from women with breast cancer.
Detailed description
OBJECTIVES:
- To develop new in vivo models of human breast cancer.
- To correlate response in this model to actual treatment outcome in patients, if the in vivo model is proven feasible.
OUTLINE: Previously collected breast tumor fragments are implanted into the renal capsule site of SCID mouse hosts (mouse with severe combined immune deficiency) to establish metastatic spread patterns, and both histologic and molecular tumor characteristics.
Patients' medical charts are reviewed to obtain relevant information, including general demographics, smoking and alcohol use, as well as outcome data such as survival and response to treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast cancer patients | – | Other: laboratory biomarker analysis, Other: medical chart review |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- breast cancer patients
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 |
|---|---|---|
| laboratory biomarker analysisTissue samples will either be collected at the time of medically indicated surgical procedures or through research core biopsies. A sample of urine will also be obtained. Blood will be collected via venipuncture and lymphocytes (mononuclear cells) separated and processed as a source of normal DNA and normal cells. | Other | breast cancer patients |
| medical chart reviewpatient chart review will occur in conjunction with patient data collection for final analyses. | Other | breast cancer patients |
Primary outcome
Development of new in vivo models of human breast cancer
Time frame: 1 year
Correlation of response in this model to actual treatment outcome in patients, if the in vivo model proven feasible
Time frame: 5 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 4 May 2018.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink 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.
A. Bapsi Chakravarthy, MD principal investigator
Vanderbilt-Ingram 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 Vanderbilt-Ingram 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?
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 4 May 2018. 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?
Development of new in vivo models of human breast cancer (time frame: 1 year). The study lists 2 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 4 May 2018.