DiabetesNCT00793390
Case-Control Study of Inflammatory Breast Cancer in North Africa
An observational study of Diabetes, run by National Cancer Institute (NCI) at 6 sites in 3 countries.
Trial summary
Background: Inflammatory breast cancer (IBC) is a rare, poorly understood and particularly aggressive form of breast cancer. Three characteristics of IBC tumors their rapid progression, their extensive formation of new blood vessels, and the fact that these characteristics are present from the inception of the tumor… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Diabetes
- How many people
- 815 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 17 Nov 2008to 30 Sep 2018
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients at study hospitals and visitors to study hospitals.
- The case-control study will be restricted to women at least 18 years of age. IBC cases will be defined as having any clinical signs of redness, and either edema or peau d' orange characteristic of IBC or evidence of tumor emboli in the dermal lymphatics (at the center in Rabat).
Cases with extensive ulceration of the breast or with breast carcinoma 'en cuirasse' will be excluded from the study, even if erythema is present.
Women with a previous diagnosis of breast cancer will be excluded.
All cancers will be pathologically confirmed with evidence of tumor in either the breast parenchyma or dermal lymphatics based on the diagnostic biopsy.
Cases newly diagnosed and/or treated at study hospitals will be included.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Egypt3 sites
National Cancer Institute-Cairo
Cairo
Gharbia Cancer Society
Gharbia
Tanta Cancer Center
Tanta
Morocco2 sites
Ibn Rochd Oncology Center
Casablanca
University Hospital Center Mohammed VI
Marrakesh
About this study
Official title: A Case-Control Study of Inflammatory Breast Cancer in North Africa
Background:
- Inflammatory breast cancer (IBC) is a rare, poorly understood and particularly aggressive form of breast cancer.
- Three characteristics of IBC tumors their rapid progression, their extensive formation of new blood vessels, and the fact that these characteristics are present from the inception of the tumor make it an ideal model for studying factors associated with tumor aggressiveness.
- This study is a collaboration among several institutions in the United States and North Africa that have extensive epidemiological experience and experience with IBC.
Read more
Objectives:
- To understand what causes certain types of breast conditions, including IBC.
Eligibility:
- Women 18 years of age and older with IBC and non-IBC and healthy women volunteers are eligible. Women who have had a previous diagnosis of any kind of breast cancer are excluded.
Design:
- Participants complete a questionnaire providing information about their background, including medical and reproductive history, family health history and lifestyle habits and undergo the following additional procedures:
- Height, weight, hip and chest measurements.
- Saliva sample collection to measure biological factors that may be related to breast conditions.
- Breast examination and, if permission is given, photographs of affected breast.
- Analysis of biopsied tissue for genetic and biochemical factors.
Read the detailed description
Inflammatory breast cancer (IBC) is a rare, poorly understood and particularly aggressive form of breast cancer characterized by diffuse erythema and edema/peau d orange of the breast. The proposed case-control study of risk factors for IBC will include approximately 400 IBC cases accrued over a two-year period in centers in four countries in North Africa (the major cancer center and selected private clinicians in Tunisia, the major cancer center in Egypt, 2 cancer centers in Algeria, and 2 cancer centers in Morocco). Two control groups will be included: 1) 400 non-IBC breast cancer cases and; 2) 400 visitor controls (excluding those with breast, ovarian, endometrial, and nasopharyngeal cancers) in the study hospitals. The study will involve the administration of a questionnaire, anthropometric measurements, and saliva collection for all study subjects. In addition, digital photographs of the breasts will be collected for IBC cases, and a clinical examination form and paraffin-embedded tumor tissue will be collected for IBC cases and non-IOBC breast cancer controls. The study will be conducted as a consortium, with form development and translation coordinated at the National Cancer Institute (USA). A review of study procedures will be done after the first three months of data collection. The National Cancer Institute (NCI)-Division of Cancer Epidemiology and Genetics (DCEG), NCI-Office of International Affairs (OIA), University of Michigan, and International Breast Cancer Research Foundation (IBCRF) will provide funding for the project.
- Conditions
- Diabetes
- Keywords
- Aggressive Breat Cancer
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| inflammatory breast cancer cases | inflammatory breast cancer cases | |
| non-inflammotory breast cancer cases | non-inflammatory breast cancer cases | |
| visitor controls without cancer | visitor controls without breast cancer- those visiting cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast cancer
a rare type of breast cancer assessed clinically by study clinicians.
Measured: retrospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study start17 Nov 2008
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 815 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gretchen Benson, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793390
- Sponsor's protocol ID
- 999909033
- Other IDs
- 09-C-N033
- Status last verified
- Dec 2020
- First submitted
- 18 Nov 2008
- Last updated
- 24 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-Control Study of Inflammatory Breast Cancer in North Africa
- ClinicalTrials.gov ID
- NCT00793390
- Acronym / sponsor ID
- 999909033
- Conditions
- Diabetes
- Keywords
- Aggressive Breat Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 815 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 17 Nov 2008 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 19 Nov 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.
Background:
- Inflammatory breast cancer (IBC) is a rare, poorly understood and particularly aggressive form of breast cancer.
- Three characteristics of IBC tumors their rapid progression, their extensive formation of new blood vessels, and the fact that these characteristics are present from the inception of the tumor make it an ideal model for studying factors associated with tumor aggressiveness.
- This study is a collaboration among several institutions in the United States and North Africa that have extensive epidemiological experience and experience with IBC.
Objectives:
- To understand what causes certain types of breast conditions, including IBC.
Eligibility:
- Women 18 years of age and older with IBC and non-IBC and healthy women volunteers are eligible. Women who have had a previous diagnosis of any kind of breast cancer are excluded.
Design:
- Participants complete a questionnaire providing information about their background, including medical and reproductive history, family health history and lifestyle habits and undergo the following additional procedures:
- Height, weight, hip and chest measurements.
- Saliva sample collection to measure biological factors that may be related to breast conditions.
- Breast examination and, if permission is given, photographs of affected breast.
- Analysis of biopsied tissue for genetic and biochemical factors.
Detailed description
Inflammatory breast cancer (IBC) is a rare, poorly understood and particularly aggressive form of breast cancer characterized by diffuse erythema and edema/peau d orange of the breast. The proposed case-control study of risk factors for IBC will include approximately 400 IBC cases accrued over a two-year period in centers in four countries in North Africa (the major cancer center and selected private clinicians in Tunisia, the major cancer center in Egypt, 2 cancer centers in Algeria, and 2 cancer centers in Morocco). Two control groups will be included: 1) 400 non-IBC breast cancer cases and; 2) 400 visitor controls (excluding those with breast, ovarian, endometrial, and nasopharyngeal cancers) in the study hospitals. The study will involve the administration of a questionnaire, anthropometric measurements, and saliva collection for all study subjects. In addition, digital photographs of the breasts will be collected for IBC cases, and a clinical examination form and paraffin-embedded tumor tissue will be collected for IBC cases and non-IOBC breast cancer controls. The study will be conducted as a consortium, with form development and translation coordinated at the National Cancer Institute (USA). A review of study procedures will be done after the first three months of data collection. The National Cancer Institute (NCI)-Division of Cancer Epidemiology and Genetics (DCEG), NCI-Office of International Affairs (OIA), University of Michigan, and International Breast Cancer Research Foundation (IBCRF) will provide funding for the project.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| inflammatory breast cancer cases | – | –inflammatory breast cancer cases |
| non-inflammotory breast cancer cases | – | –non-inflammatory breast cancer cases |
| visitor controls without cancer | – | –visitor controls without breast cancer- those visiting cancer patients |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at study hospitals and visitors to study hospitals.
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
breast cancer
Time frame: retrospective
a rare type of breast cancer assessed clinically by study clinicians.
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 24 Dec 2020.
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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.
Gretchen Benson, Ph.D. principal investigator
National Cancer Institute (NCI)
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by National Cancer Institute (NCI) at 6 sites in 3 countries.
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 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Egypt, Morocco, 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.
What does the primary outcome measure?
breast cancer (time frame: retrospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.