Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344071
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-23
Brief Title:
Pilot Study of Inflammatory Breast Cancer in Egypt and Tunisia
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study of Inflammatory Breast Cancer in Egypt and Tunisia
Status:
COMPLETED
Status Verified Date:
2009-09-23
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:
One form of breast cancer known as inflammatory breast cancer IBC is characterized by diffuse erythema redness and edema peau dorange of the breast This type of cancer is aggressive and poorly understood It is rare in the United States about 4 percent of cases but more common in Egypt and Tunisia up to 23 percent of cases Conducting a case-control study of IBC is complicated by several factors including the lack of standardized criteria for IBC In addition collecting pre-chemotherapy tissue and blood samples from IBC patients is difficult because treatment begins immediately after diagnosis
In this pilot study the National Cancer Institute will collaborate with two major cancer centers and two hospitals in Egypt and Tunisia to determine the feasibility of a case-control study of IBC The study will assess the number and characteristics of IBC cases the feasibility of identifying cases at diagnosis and the availability of control subjects will collect frozen pre-treatment tumor tissue from five IBC cases to determine whether RNA isolation is possible will obtain digital photographs of the breasts of IBC cases and will demonstrate collaboration between the institutions and personnel involved in the study The study will last for approximately one year
Participating hospitals will identify IBC cases Consenting patients will undergo a breast examination in which the examining surgeon will complete an Initial Examination Form IEF Digital photographs of the breasts but not face will be taken and linked to the study ID number Tissue examination results will be entered into the IEF For five selected cases additional pre-treatment tumor tissue will be collected and frozen
This pilot study will assess the availability of controls for a case-control study by investigating the number and type of admissions to the Ear Nose and Throat and Ophthalmology Departments at participating hospitals during 2000-2003 using computerized records
In this pilot study the National Cancer Institute will collaborate with two major cancer centers and two hospitals in Egypt and Tunisia to determine the feasibility of a case-control study of IBC The study will assess the number and characteristics of IBC cases the feasibility of identifying cases at diagnosis and the availability of control subjects will collect frozen pre-treatment tumor tissue from five IBC cases to determine whether RNA isolation is possible will obtain digital photographs of the breasts of IBC cases and will demonstrate collaboration between the institutions and personnel involved in the study The study will last for approximately one year
Participating hospitals will identify IBC cases Consenting patients will undergo a breast examination in which the examining surgeon will complete an Initial Examination Form IEF Digital photographs of the breasts but not face will be taken and linked to the study ID number Tissue examination results will be entered into the IEF For five selected cases additional pre-treatment tumor tissue will be collected and frozen
This pilot study will assess the availability of controls for a case-control study by investigating the number and type of admissions to the Ear Nose and Throat and Ophthalmology Departments at participating hospitals during 2000-2003 using computerized records
Detailed Description:
Breast cancer characterized by diffuse erythema and edema or peau dorange of the breast inflammatory breast cancer IBC is rare particularly aggressive and poorly understood The extent of redness and edema or peau dorange of the breast required for a diagnosis of IBC has not been standardized According to the most recent American Joint Committee on Cancer AJCC definition of inflammatory breast cancer the signs of redness and edema or peau dorange should cover the majority of the breast and should have arisen quickly Breast cancers with redness and edema or peau dorange account for approximately 4 percent of breast cancers in the United States but up to 23 percent of breast cancers in Egypt and Tunisia
The proposed pilot study will determine the feasibility of conducting a case-control study of inflammatory breast cancer in collaboration with the National Cancer Institute-Cairo Egypt and the Institut Salah Azaiz Tunis Tunisia the major cancer centers in Egypt and Tunisia and Cairo University Hospital and Charles Nicolle Hospital affiliated general hospitals from which controls will be selected Currently neither case study hospital collects data on the number of inflammatory breast cancer cases meeting the AJCC definition which will be used for the proposed case-control study In addition the geographic distribution of IBC cases at the two study hospitals knowledge of which is necessary for the selection of appropriate controls is unknown
The goals of the pilot study are to assess the feasibility of the following critical components of the case-control study 1 identifying a sufficient number of IBC cases at the time of diagnosis in the two study hospitals 2 selecting appropriate hospital-based control subjects 3 collecting frozen pre-treatment tumor tissue 4 obtaining digital photographs of the breasts of IBC cases and 5 communicating and working collaboratively with the study hospitals and personnel in Egypt and Tunisia To accomplish these objectives IBC cases meeting the AJCC definition as well as cases meeting other definitions of IBC will be identified over a one-year period at each of the two study hospitals Computerized records at the control hospital for the years 2000-2003 will be used to enumerate the number of female patients with non-chronic diseases and their age and geographic distribution in the Departments of Ophthalmology and Ear Nose and Throat ENT Pre-treatment frozen tumor tissue and digital photographs of the breast will be collected from five IBC cases at each study site
The proposed pilot study will determine the feasibility of conducting a case-control study of inflammatory breast cancer in collaboration with the National Cancer Institute-Cairo Egypt and the Institut Salah Azaiz Tunis Tunisia the major cancer centers in Egypt and Tunisia and Cairo University Hospital and Charles Nicolle Hospital affiliated general hospitals from which controls will be selected Currently neither case study hospital collects data on the number of inflammatory breast cancer cases meeting the AJCC definition which will be used for the proposed case-control study In addition the geographic distribution of IBC cases at the two study hospitals knowledge of which is necessary for the selection of appropriate controls is unknown
The goals of the pilot study are to assess the feasibility of the following critical components of the case-control study 1 identifying a sufficient number of IBC cases at the time of diagnosis in the two study hospitals 2 selecting appropriate hospital-based control subjects 3 collecting frozen pre-treatment tumor tissue 4 obtaining digital photographs of the breasts of IBC cases and 5 communicating and working collaboratively with the study hospitals and personnel in Egypt and Tunisia To accomplish these objectives IBC cases meeting the AJCC definition as well as cases meeting other definitions of IBC will be identified over a one-year period at each of the two study hospitals Computerized records at the control hospital for the years 2000-2003 will be used to enumerate the number of female patients with non-chronic diseases and their age and geographic distribution in the Departments of Ophthalmology and Ear Nose and Throat ENT Pre-treatment frozen tumor tissue and digital photographs of the breast will be collected from five IBC cases at each study site
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 |
|---|---|---|---|
| 04-C-N284 | None | None | None |