Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340158
Status:
COMPLETED
Last Update Posted:
2010-04-23
First Post:
2006-06-19
Brief Title:
Establishing an Inflammatory Breast Cancer Registry
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Establishment of an Inflammatory Breast Cancer Registry and Biospecimen Repository
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-N214 | None | None | None |