Carbonic Anhydrase IX Enzyme in Triple Negative Breast Carcinoma

March 6, 2024 updated by: Mehmet Buğra Bozan, Kahramanmaras Sutcu Imam University

Carbonic Anhydrase IX Enzyme in Triple Negative Breast Carcinoma: Relationship With Prognostic Factors and Response to Neoadjuvant Chemotherapy

Triple-negative breast carcinoma is characterized by the absence of estrogen receptors, progesterone receptors, and HER2/neu receptors. Carbonic anhydrase IX (CA IX) is a tumor-associated cell surface glycoprotein that is involved in adaptation to hypoxia-induced acidosis and plays a role in cancer progression. This study aimed to investigate CA IX expression in TNBC and its relationship with treatment effect.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tru-cut biopsy materials, sent to our hospital pathology laboratory between August 2018 and May 2023, will be examined. Invasive carcinoma cases will be evaluated according to estrogen, progesterone, and HER 2 receptor levels. Triple-negative tumor cases were isolated and those cases who underwent breast resection in our hospital after receiving neoadjuvant chemotherapy (Adriamycin, cyclophosphamide, and then paclitaxel for 4 cycles) were included in the study.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

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

Study Locations

  • Turkey
      • Kahramanmaraş, Turkey, 46000
        • Kahramanmaraş Sütçü İmam 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Triple Negative Breast Cancer cases who were operated in Elazığ Fethi Sekin SUAM

Description

Inclusion Criteria:

  • Older than 18 years
  • Triple-negative mastectomy cases
  • Patients whose data can be available
  • Patients who were operated in our hospital

Exclusion Criteria:

  • Younger than 18 years
  • Not triple negative mastectomy cases
  • Patients with missing data
  • Patients who were operated in another hospital

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low Staining
CA IX is a transmembrane protein, it exhibits cytoplasmic membrane staining. Immunohistochemically positive cells were graded as Low staining if they constituted <10% of the total.
Diagnostic test: Carbonic anhydrase staining levels
CA IX is a transmembrane protein, it exhibits cytoplasmic membrane staining. Immunohistochemically positive cells were graded as Low staining if they constituted <10% of the total and high staining if they constituted ≥ 10% (15).
High Staining
CA IX is a transmembrane protein, it exhibits cytoplasmic membrane staining. Immunohistochemically positive cells were graded as high staining if they constituted ≥ 10%
Diagnostic test: Carbonic anhydrase staining levels
CA IX is a transmembrane protein, it exhibits cytoplasmic membrane staining. Immunohistochemically positive cells were graded as Low staining if they constituted <10% of the total and high staining if they constituted ≥ 10% (15).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Poor prognostic factors in patients with TNBC
Time Frame: 2018-2023
Higher staining CA IX levels (≥ 10%) in TNBC patients' pathological specimens is a poor prognostic factor
2018-2023
The treatment success with inhibiting the CA IX enzyme levels' effectiveness
Time Frame: 2018-2023
Treatment success in TNBC patients by evaluating changes in CA IX staining levels
2018-2023

Collaborators and Investigators

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

Sponsor

Kahramanmaras Sutcu Imam University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 1, 2018

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 2023/04-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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