Inflammatory Breast CancerNCT00340158
Establishing an Inflammatory Breast Cancer Registry
An observational study of Inflammatory Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast cancer that disproportionately impacts young women. IBC often affects the skin of the breast, as well as the breast itself, making it appear inflamed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Inflammatory Breast Cancer
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to not given
- 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
- Patients will be recruited from collaborating institutions throughout the US and through the IBC research foundation (established by patient advocate, Mr. Owen Johnson), which maintains a website and a research e-mail list. The goal is to recruit approximately 300 volunteers, at least 18 years of age or older.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: The Establishment of an Inflammatory Breast Cancer Registry and Biospecimen Repository
Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast cancer that disproportionately impacts young women. IBC often affects the skin of the breast, as well as the breast itself, making it appear inflamed. The purpose of this study is to collect data and information on IBC patients so that researchers can study factors associated with IBC. The data and information collected will be used to establish the IBC Registry, a private cancer registry.
Approximately 300 persons who are 18 years or older and who have been diagnosed with IBC will participate in this study. Participants will provide researchers with access to their medical and pathology records, slides, tissue, and x-rays. They also will consent to a 15-minute telephone interview concerning general information about themselves and the initial manifestation of IBC and to a 30-minute interview about their medical history.
Read the detailed description
Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast carcinoma that disproportionately affects young women. Clinical features of IBC include warmth, redness, edema, skin dimpling and rapid enlargement; the hallmark pathologically is dermal lymphatic invasion. Minimal criteria necessary for a clinical diagnosis of IBC have been debated and relatively little is known about the epidemiology, pathogenesis and molecular characteristics of these very lethal tumors. This project, funded by a grant from the Department of Defense awarded to PHL, would develop a national registry of approximately 300 volunteers (aged 18 years or older) with IBC. Subjects will provide access to medical records, pathology records, slides, blocks and tissue (fixed and frozen) and x-rays and consent to an interview. Recruitment will be performed at collaborating institutions and through an IBC research foundation (Owen Johnson) that maintains a website and e-mail contact lists. The registry resources would be made available collaboratively to anyone in the breast cancer research community, based on merit as determined by a designated committee. Central aims of the study include determining whether clinically or pathologically defined IBC differs in clinical behavior or biologically, identifying markers in IBC that may provide useful information about the aggressive potential of breast cancers generally, and evaluation of tissue for mouse mammary tumor virus (MMTV) related sequences. The purpose of this IRB submission is to review the role of MES as a collaborating pathologist on this study. Enrollment is closed as of this time.
- Conditions
- Inflammatory Breast Cancer
- Keywords
- Mammary, Diagnosis, Aggressive, Pathology, Epidemiology
- Medical subject headings
- Inflammatory Breast Neoplasms, Disease, Aggression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study startJun 2003
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 Inflammatory Breast CancerStudies 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
- Time perspective
- Retrospective
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- United States Department of Defense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340158
- Sponsor's protocol ID
- 999903214
- Other IDs
- 03-C-N214
- Status last verified
- Apr 2009
- First submitted
- 19 Jun 2006
- Last updated
- 23 Apr 2010
- Results posted
- No
Publications
Levine PH, Steinhorn SC, Ries LG, Aron JL. Inflammatory breast cancer: the experience of the surveillance, epidemiology, and end results (SEER) program. J Natl Cancer Inst. 1985 Feb;74(2):291-7.
PubMed 3856043Chang S, Parker SL, Pham T, Buzdar AU, Hursting SD. Inflammatory breast carcinoma incidence and survival: the surveillance, epidemiology, and end results program of the National Cancer Institute, 1975-1992. Cancer. 1998 Jun 15;82(12):2366-72.
PubMed 9635529Mourali N, Levine PH, Tabanne F, Belhassen S, Bahi J, Bennaceur M, Herberman RB. Rapidly progressing breast cancer (poussee evolutive) in Tunisia: studies on delayed hypersensitivity. Int J Cancer. 1978 Jul 15;22(1):1-3. doi: 10.1002/ijc.2910220102.
PubMed 681022
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Establishment of an Inflammatory Breast Cancer Registry and Biospecimen Repository
- ClinicalTrials.gov ID
- NCT00340158
- Acronym / sponsor ID
- 999903214
- Conditions
- Inflammatory Breast Cancer
- Keywords
- Mammary, Diagnosis, Aggressive, Pathology, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- United States Department of Defense
- Study start
- Jun 2003
- First posted
- 21 Jun 2006 (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.
Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast cancer that disproportionately impacts young women. IBC often affects the skin of the breast, as well as the breast itself, making it appear inflamed. The purpose of this study is to collect data and information on IBC patients so that researchers can study factors associated with IBC. The data and information collected will be used to establish the IBC Registry, a private cancer registry.
Approximately 300 persons who are 18 years or older and who have been diagnosed with IBC will participate in this study. Participants will provide researchers with access to their medical and pathology records, slides, tissue, and x-rays. They also will consent to a 15-minute telephone interview concerning general information about themselves and the initial manifestation of IBC and to a 30-minute interview about their medical history.
Detailed description
Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast carcinoma that disproportionately affects young women. Clinical features of IBC include warmth, redness, edema, skin dimpling and rapid enlargement; the hallmark pathologically is dermal lymphatic invasion. Minimal criteria necessary for a clinical diagnosis of IBC have been debated and relatively little is known about the epidemiology, pathogenesis and molecular characteristics of these very lethal tumors. This project, funded by a grant from the Department of Defense awarded to PHL, would develop a national registry of approximately 300 volunteers (aged 18 years or older) with IBC. Subjects will provide access to medical records, pathology records, slides, blocks and tissue (fixed and frozen) and x-rays and consent to an interview. Recruitment will be performed at collaborating institutions and through an IBC research foundation (Owen Johnson) that maintains a website and e-mail contact lists. The registry resources would be made available collaboratively to anyone in the breast cancer research community, based on merit as determined by a designated committee. Central aims of the study include determining whether clinically or pathologically defined IBC differs in clinical behavior or biologically, identifying markers in IBC that may provide useful information about the aggressive potential of breast cancers generally, and evaluation of tissue for mouse mammary tumor virus (MMTV) related sequences. The purpose of this IRB submission is to review the role of MES as a collaborating pathologist on this study. Enrollment is closed as of this time.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 23 Apr 2010.
- Background: PubMed 3856043Levine PH, Steinhorn SC, Ries LG, Aron JL. Inflammatory breast cancer: the experience of the surveillance, epidemiology, and end results (SEER) program. J Natl Cancer Inst. 1985 Feb;74(2):291-7.
- Background: PubMed 9635529Chang S, Parker SL, Pham T, Buzdar AU, Hursting SD. Inflammatory breast carcinoma incidence and survival: the surveillance, epidemiology, and end results program of the National Cancer Institute, 1975-1992. Cancer. 1998 Jun 15;82(12):2366-72.
- Background: PubMed 681022Mourali N, Levine PH, Tabanne F, Belhassen S, Bahi J, Bennaceur M, Herberman RB. Rapidly progressing breast cancer (poussee evolutive) in Tunisia: studies on delayed hypersensitivity. Int J Cancer. 1978 Jul 15;22(1):1-3. doi: 10.1002/ijc.2910220102.
Related trials for Inflammatory Breast Cancer
Active, not recruitingPhase 2
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
Inflammatory Breast Cancer, Stage IIA Breast Cancer
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Effects of SPSIP Block on Perioperative Inflammation and TLR4 in Breast Cancer Surgery
Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Breast Cancer
Not yet recruiting
Feasibility and Effectiveness of Sentinel Lymph Node Biopsy in Inflammatory Breast Cancer
Breast Cancer
RecruitingPhase 2
TRUDI: TDXD+Durva in HER2+/Low IBC
Invasive Breast Cancer, Inflammatory Breast Cancer Stage III
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Inflammatory Breast Cancer, 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?
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 23 Apr 2010. 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 NCT00340158, 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 23 Apr 2010.