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Inflammatory Breast CancerNCT00344071

Pilot Study of Inflammatory Breast Cancer in Egypt and Tunisia

An observational study of Inflammatory Breast Cancer, run by National Cancer Institute (NCI) at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

One form of breast cancer, known as inflammatory breast cancer (IBC), is characterized by diffuse erythema (redness) and edema (peau d'orange) of the breast. This type of cancer is aggressive and poorly understood. Read more about this study

Who is it for?
Any age
Conditions the study is for
Inflammatory Breast Cancer
How many people
250 participants
Where
4 sitesin 2 countries
Study dates
8 Sep 2004to 27 Apr 2007
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All patients with redness and edema or peau d'orange, of the breast who are seen at the National Cancer-Cairo, Egypt or the Institute Salah Azair in Tunis, Tunisia during the period June 1, 2004 to May 31, 2005 will be eligible for the pilot study.

Who cannot join

None listed.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Egypt2 sites
  • Cairo University Hospital

    Cairo

  • National Cancer Institute-Cairo

    Cairo

Other trials in Egypt

Tunisia2 sites
  • Association Tunisienne de lutte contre le Cancer (ATCC, le conseil

    Tunis

  • Charles Nicolle Hospital, Tunisia

    Tunis

Other trials in Tunisia

About this study

One form of breast cancer, known as inflammatory breast cancer (IBC), is characterized by diffuse erythema (redness) and edema (peau d'orange) 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.

Read more

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.

Read the detailed description

Breast cancer characterized by diffuse erythema and edema, or peau d'orange, of the breast (inflammatory breast cancer (IBC)) is rare, particularly aggressive, and poorly understood. The extent of redness and edema or peau d'orange, 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 d'orange, should cover the majority of the breast, and should have arisen quickly. Breast cancers with redness and edema or peau d'orange, 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.

Keywords
Clinical, Tissue, Photographs, Women, Case-Control
Medical subject headings
Inflammatory Breast Neoplasms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2006 (estimated)
  2. Study start8 Sep 2004
  3. Primary completion27 Apr 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
250 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00344071
Sponsor's protocol ID
999904284
Other IDs
04-C-N284
Status last verified
23 Sep 2009
First submitted
23 Jun 2006
Last updated
2 Jul 2017
Results posted
No

Publications

  • Attia-Sobol J, Ferriere JP, Cure H, Kwiatkowski F, Achard JL, Verrelle P, Feillel V, De Latour M, Lafaye C, Deloche C, et al. Treatment results, survival and prognostic factors in 109 inflammatory breast cancers: univariate and multivariate analysis. Eur J Cancer. 1993;29A(8):1081-8. doi: 10.1016/s0959-8049(05)80292-8.

    PubMed 8518016
  • Classon M, Settleman J. Emerging concepts in tumor progression and therapy. Semin Cancer Biol. 2000 Dec;10(6):393-7. doi: 10.1006/scbi.2000.0338. No abstract available.

    PubMed 11170861
  • Helal T, Nassiri M, Khalifa A. Immunohistochemical markers of tumor prognosis in breast cancer in Egypt. Cancer Detect Prev. 1997;21(3):201-6.

    PubMed 9167036

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Breast Cancer, run by National Cancer Institute (NCI) at 4 sites in 2 countries.

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 1 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 4 sites in Egypt, Tunisia. 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 NCT00344071, 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.

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