CD133 Expression in Mammary Invasive Ductal Carcinoma

May 5, 2021 updated by: Nagwa Abd El-Sadek Ahmed, Sohag University

Significance of CD133 Expression in Invasive Ductal Carcinoma of the Breast

Background and Aim: Breast carcinoma is the most common type of cancer and the most common cause of cancer-related mortality among women worldwide. Cancer stem cells (CSCs) are thought to be responsible for tumor initiation, progression, dissemination and resistance to chemotherapy and radiotherapy. CD133 is a trans-membrane glycoprotein which is considered as a putative CSCs marker. It has been extensively used as a stem cell marker for normal and cancerous tissues. Emerging evidence suggests that CD133 may be a critical factor in tumor development, progression and metastasis. The aim of this study was to evaluate expression status of CD133 in invasive ductal carcinoma (IDC) of the breast and its role during breast cancer progression and to correlate its expression with some known clinicopathological parameters.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Introduction:

Breast carcinoma is the most frequent malignant tumor in women worldwide comprising 30% on average of all cancers and the most likely cause of cancer-related deaths in women worldwide. In Egypt, according to the official statistics of the National Cancer Institute, Cairo University, breast carcinoma is the most prevalent cancer among women representing 35.1% of total cancer cases.

Breast carcinoma is currently regarded as a heterogeneous group of tumors with diverse morphology, behavior, outcome and response to therapy. In spite of advances in diagnosis and treatment of breast carcinoma, the clinical outcome remains unsatisfactory due to recurrence, metastasis or chemotherapy-resistance.

Cancer stem cells (CSCs) are recognized as a subpopulation of cancer cells that show the characteristics of normal stem cells. They are believed to possess the capacity to self-renewal and are responsible for tumor formation and progression. CSCs also promote tumor cell heterogeneity and metastasis. In addition, CSCs are thought to be more resistant to chemotherapy and radiotherapy. Given the significance of CSCs in tumor development, the identification and characterization of CSCs could lead to the development of directed therapies against these aggressive cells, hence more effective treatments for cancer.

Over recent years, CSCs have been described in different types of cancers including breast cancer. In the mammary gland, the microenvironment provides clues to control the behavior of epithelial stem and progenitor cells. Breast cancer stem cells (BCSCs) subpopulation was shown to express higher level of pro-invasive genes and had highly invasive properties.

With evidence forthcoming regarding the effects of the stroma and the microenvironment in breast tumor progression, several genes have also been reported to be associated with BCSCs. The phenomenon of epithelial-mesenchymal transition (EMT) is important discovery during progression of breast carcinoma and explanation for their ability to invade and to colonize other parts of the body. With all these knowledge, targeting BCSCs for breast carcinoma treatment was demanded.

CD133, also known as prominin-1, is a member of pentaspan trans-membrane glycoproteins, frequently expressed on multipotent progenitor cells, including immature hematopoietic stem and progenitor cells. CD133 is a putative CSCs marker; it has been extensively used as a stem cell marker for normal and cancerous tissues. CD133 expressing cells possessing stem cell-like characteristics including self-renewal, high proliferation and drug resistance substantiating a tumorigenic role of CD133-expressing cells. It also plays a role in cell differentiation, proliferation and apoptosis.

Emerging evidences suggest that CD133 may be a critical factor in tumor development, progression and metastasis. CD133-positive CSC showed increased expression levels of CXCR4 which is a critical protein for the adhesion and/or migration of tumor cells, indicating an important role of CD133 in tumor cells migration and tumor invasion. CD133 is used as a diagnostic and prognostic marker which is overexpressed in various neoplasms. In breast cancer, its overexpression confers a poor prognosis. Increasing clinical evidence has confirmed that it is involved in breast cancer progression. CD133 is a promising marker for the identification of CSC in breast cancer subtypes including aggressive HER2+ and triple-negative classes.

Aim of This Work:

The aim of this study is to

  1. Detect the immunohistochemical expression of CD133 in mammary invasive ductal carcinoma (IDC) and to correlate its expression with some known clinicopathological parameters.
  2. Correlate the IHC expression of CD133 with some known clinicopathological parameters in mammary IDC.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Faculty of Medicine, Sohag University
        • Contact:
          • Ahmed Rhoshdi, assistent prof
      • Sohag, Egypt
        • Not yet recruiting
        • Faculty of Medicine, Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

• Patients: Fifty specimens of IDC obtained from patients who underwent mastectomy in General Surgery Department of Sohag Faculty of Medicine according to local Ethical Committee regulations, to be examined in the Pathology Laboratory of the same faculty.

Description

Inclusion Criteria:• Inclusion criteria: Patients with IDC and underwent mastectomy or excisional biopsy of breast mass.

-

Exclusion Criteria

  • Patients received pre-operative chemotherapy or radiotherapy.
  • Patients with insufficient clinical data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
1. Detect the immunohistochemical expression of CD133 in mammary invasive ductal carcinoma (IDC) and to correlate its expression with some known clinicopathological parameters.
Time Frame: 1 month
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
2. Correlate the IHC expression of CD133 with some known clinicopathological parameters in mammary IDC.
Time Frame: 1 months
1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CD133, Breast Cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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