Breast NeoplasmsNCT00646555
Inflammatory Breast Cancer, Tumor Markers, and Factors Associated With Angiogenesis
An observational study of Breast Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study, conducted by the NCI and the George Washington University Medical Center (GWUMC), will examine breast tissue from patients with inflammatory breast cancer (IBC) for tumor markers and factors associated with angiogenesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2003to 10 Apr 2012
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with inflammatory breast cancer.
- Age greater than 18 years.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
GW University Medical Center GW Hospital Center
Washington D.C., District of Columbia, 20037
About this study
Official title: Evaluation of Angiogenesis Parameters and Tumor Markers in Inflammatory Breast Cancer Specimens
This study, conducted by the NCI and the George Washington University Medical Center (GWUMC), will examine breast tissue from patients with inflammatory breast cancer (IBC) for tumor markers and factors associated with angiogenesis. Angiogenesis is the formation of new blood vessels that is essential for tumor growth and spread. IBC is an extremely rare, aggressive form of breast cancer that disproportionately affects young women. The risk factors for IBC, its cause, and how it develops are unknown, but the disease appears to involve a high degree of angiogenesis.
Tissue specimens for this study will be obtained from GWUMC's Inflammatory Breast Cancer Registry and Biospecimen Repository. The registry was established to develop a national registry of patients with IBC that includes standardized clinical, epidemiological, and pathological information, along with disease recurrence and survival data.
For this study, tissue specimens from the repository will be tested for biological markers and angiogenesis parameters to help in the classification of the tumors. Biological markers (such as estrogen receptor, progesterone receptor, the p53 gene, and others) and angiogenesis parameters (such as various proteins involved in vessel formation) will be examined to determine their prevalence in tissue specimens and their relationship to patient survival. When possible, the findings will be compared with non-IBC tissue samples.
Read the detailed description
Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast cancer that disproportionately affects young women. The risk factors and pathogenesis of these tumors are unknown and it is unclear whether tumors showing various clinical, pathological or molecular features behave differently. IBC appears to be a highly angiogenic tumor. In this study, tumor markers and parameters of angiogenesis will be further investigated in IBC.
The Inflammatory Breast Cancer Registry and Biospecimen Repository is a project funded by a grant from the Department of Defense to Paul H. Levine at GWUMC. The purpose of the registry is to develop a national registry of patients with IBC that will contain standardized clinical, epidemiological, and pathological information, along with recurrence and survival data. The goal is to obtain specimens from approximately 150 patients with IBC. The data in the registry and repository will be made available to researchers to aid in the development of a clinicopathological diagnosis of IBC. Investigators at GWUMC will consent recruited patients and collect clinical data. Subjects will not be recruited, evaluated, or monitored at the NCI. The GWUMC IRB will oversee human subjects protection issues. All samples obtained from GWUMC will be blinded and coded to the NCI investigators. In addition to the samples from George Washington University, we will obtain 150 control samples from the National Cancer Institute Cooperative Breast Cancer Tissue Resource. These samples were not available when this protocol was first submitted.
In collaboration with George Washington University Medical Center (GWUMC), we plan to test tissue specimens collected in the IBC registry and biospecimen repository. We will obtain frozen tissue (tissue and/or normal) and paraffin-embedded tissue blocks from each case. Genetic testing will not be performed on any of the samples. One pathologist reviews cases for grade and lymphovascular invasion (LVI) based on H\& E staining. Specimens will be tested for biological markers associated with IBC to help in classification of these tumors. These include ER, E-cadherin, podoplanin, ReIB, RhoC and vasodilator-stimulated phosphoprotein (VASP). Angiogenesis parameters will also be evaluated. These include hypoxia-inducible factor 1 alpha (HIF-1 alpha), vascular endothelial growth factor D (VEGF-D) protein expression, VEGF-C protein expression, VEGF-receptor 2 (VEGFR-2, Kdr) or VEGF-receptor 3 (VEGFR-3, flt-4).
- Conditions
- Breast Neoplasms
- Keywords
- Tissue Samples, VEGF Receptors, VEGF, Microvessel Density, Hypoxia Inducible Factor, Inflammatory Breast Cancer, IBC
- Medical subject headings
- Breast Neoplasms, Inflammatory Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study start20 Nov 2003
- Study completion10 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Amy Subar, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646555
- Sponsor's protocol ID
- 999904051
- Other IDs
- 04-C-N051
- Status last verified
- 10 Apr 2012
- First submitted
- 27 Mar 2008
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Folkman J. Angiogenesis and apoptosis. Semin Cancer Biol. 2003 Apr;13(2):159-67. doi: 10.1016/s1044-579x(02)00133-5.
PubMed 12654259Weidner N, Semple JP, Welch WR, Folkman J. Tumor angiogenesis and metastasis--correlation in invasive breast carcinoma. N Engl J Med. 1991 Jan 3;324(1):1-8. doi: 10.1056/NEJM199101033240101.
PubMed 1701519Gasparini G, Weidner N, Bevilacqua P, Maluta S, Dalla Palma P, Caffo O, Barbareschi M, Boracchi P, Marubini E, Pozza F. Tumor microvessel density, p53 expression, tumor size, and peritumoral lymphatic vessel invasion are relevant prognostic markers in node-negative breast carcinoma. J Clin Oncol. 1994 Mar;12(3):454-66. doi: 10.1200/JCO.1994.12.3.454.
PubMed 7509851
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Angiogenesis Parameters and Tumor Markers in Inflammatory Breast Cancer Specimens
- ClinicalTrials.gov ID
- NCT00646555
- Acronym / sponsor ID
- 999904051
- Conditions
- Breast Neoplasms
- Keywords
- Tissue Samples, VEGF Receptors, VEGF, Microvessel Density, Hypoxia Inducible Factor, Inflammatory Breast Cancer, IBC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 20 Nov 2003
- Study completion
- 10 Apr 2012
- First posted
- 28 Mar 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.
This study, conducted by the NCI and the George Washington University Medical Center (GWUMC), will examine breast tissue from patients with inflammatory breast cancer (IBC) for tumor markers and factors associated with angiogenesis. Angiogenesis is the formation of new blood vessels that is essential for tumor growth and spread. IBC is an extremely rare, aggressive form of breast cancer that disproportionately affects young women. The risk factors for IBC, its cause, and how it develops are unknown, but the disease appears to involve a high degree of angiogenesis.
Tissue specimens for this study will be obtained from GWUMC's Inflammatory Breast Cancer Registry and Biospecimen Repository. The registry was established to develop a national registry of patients with IBC that includes standardized clinical, epidemiological, and pathological information, along with disease recurrence and survival data.
For this study, tissue specimens from the repository will be tested for biological markers and angiogenesis parameters to help in the classification of the tumors. Biological markers (such as estrogen receptor, progesterone receptor, the p53 gene, and others) and angiogenesis parameters (such as various proteins involved in vessel formation) will be examined to determine their prevalence in tissue specimens and their relationship to patient survival. When possible, the findings will be compared with non-IBC tissue samples.
Detailed description
Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast cancer that disproportionately affects young women. The risk factors and pathogenesis of these tumors are unknown and it is unclear whether tumors showing various clinical, pathological or molecular features behave differently. IBC appears to be a highly angiogenic tumor. In this study, tumor markers and parameters of angiogenesis will be further investigated in IBC.
The Inflammatory Breast Cancer Registry and Biospecimen Repository is a project funded by a grant from the Department of Defense to Paul H. Levine at GWUMC. The purpose of the registry is to develop a national registry of patients with IBC that will contain standardized clinical, epidemiological, and pathological information, along with recurrence and survival data. The goal is to obtain specimens from approximately 150 patients with IBC. The data in the registry and repository will be made available to researchers to aid in the development of a clinicopathological diagnosis of IBC. Investigators at GWUMC will consent recruited patients and collect clinical data. Subjects will not be recruited, evaluated, or monitored at the NCI. The GWUMC IRB will oversee human subjects protection issues. All samples obtained from GWUMC will be blinded and coded to the NCI investigators. In addition to the samples from George Washington University, we will obtain 150 control samples from the National Cancer Institute Cooperative Breast Cancer Tissue Resource. These samples were not available when this protocol was first submitted.
In collaboration with George Washington University Medical Center (GWUMC), we plan to test tissue specimens collected in the IBC registry and biospecimen repository. We will obtain frozen tissue (tissue and/or normal) and paraffin-embedded tissue blocks from each case. Genetic testing will not be performed on any of the samples. One pathologist reviews cases for grade and lymphovascular invasion (LVI) based on H\& E staining. Specimens will be tested for biological markers associated with IBC to help in classification of these tumors. These include ER, E-cadherin, podoplanin, ReIB, RhoC and vasodilator-stimulated phosphoprotein (VASP). Angiogenesis parameters will also be evaluated. These include hypoxia-inducible factor 1 alpha (HIF-1 alpha), vascular endothelial growth factor D (VEGF-D) protein expression, VEGF-C protein expression, VEGF-receptor 2 (VEGFR-2, Kdr) or VEGF-receptor 3 (VEGFR-3, flt-4).
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with inflammatory breast cancer.
- Age greater than 18 years.
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 12654259Folkman J. Angiogenesis and apoptosis. Semin Cancer Biol. 2003 Apr;13(2):159-67. doi: 10.1016/s1044-579x(02)00133-5.
- Background: PubMed 1701519Weidner N, Semple JP, Welch WR, Folkman J. Tumor angiogenesis and metastasis--correlation in invasive breast carcinoma. N Engl J Med. 1991 Jan 3;324(1):1-8. doi: 10.1056/NEJM199101033240101.
- Background: PubMed 7509851Gasparini G, Weidner N, Bevilacqua P, Maluta S, Dalla Palma P, Caffo O, Barbareschi M, Boracchi P, Marubini E, Pozza F. Tumor microvessel density, p53 expression, tumor size, and peritumoral lymphatic vessel invasion are relevant prognostic markers in node-negative breast carcinoma. J Clin Oncol. 1994 Mar;12(3):454-66. doi: 10.1200/JCO.1994.12.3.454.
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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.
Amy Subar, Ph.D. principal investigator
National Cancer Institute (NCI)
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 Neoplasms, run by National Cancer Institute (NCI) 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 2 inclusion and 0 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00646555, which also lists 3 linked publications.
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 2 Jul 2017.