NCT06309459

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

4.8 years

First QC Date

January 10, 2024

Last Update Submit

March 6, 2024

Conditions

Keywords

Triple negative breast carcinomaCarbonic anhydrase IXTreatment effectKi67 proliferation index

Outcome Measures

Primary Outcomes (2)

  • Poor prognostic factors in patients with TNBC

    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

    Treatment success in TNBC patients by evaluating changes in CA IX staining levels

    2018-2023

Study Arms (2)

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

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

Interventions

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 StainingLow Staining

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü İmam University

Kahramanmaraş, 46000, Turkey (Türkiye)

Location

Related Publications (9)

  • Bakherad H, Ghasemi F, Hosseindokht M, Zare H. Nanobodies; new molecular instruments with special specifications for targeting, diagnosis and treatment of triple-negative breast cancer. Cancer Cell Int. 2022 Aug 6;22(1):245. doi: 10.1186/s12935-022-02665-0.

    PMID: 35933373BACKGROUND
  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PMID: 33538338BACKGROUND
  • Yin L, Duan JJ, Bian XW, Yu SC. Triple-negative breast cancer molecular subtyping and treatment progress. Breast Cancer Res. 2020 Jun 9;22(1):61. doi: 10.1186/s13058-020-01296-5.

    PMID: 32517735BACKGROUND
  • Warburg O, Wind F, Negelein E. THE METABOLISM OF TUMORS IN THE BODY. J Gen Physiol. 1927 Mar 7;8(6):519-30. doi: 10.1085/jgp.8.6.519. No abstract available.

    PMID: 19872213BACKGROUND
  • Carroll CP, Bolland H, Vancauwenberghe E, Collier P, Ritchie AA, Clarke PA, Grabowska AM, Harris AL, McIntyre A. Targeting hypoxia regulated sodium driven bicarbonate transporters reduces triple negative breast cancer metastasis. Neoplasia. 2022 Mar;25:41-52. doi: 10.1016/j.neo.2022.01.003. Epub 2022 Feb 9.

    PMID: 35150959BACKGROUND
  • Lee P, Chandel NS, Simon MC. Cellular adaptation to hypoxia through hypoxia inducible factors and beyond. Nat Rev Mol Cell Biol. 2020 May;21(5):268-283. doi: 10.1038/s41580-020-0227-y. Epub 2020 Mar 6.

    PMID: 32144406BACKGROUND
  • Godet I, Doctorman S, Wu F, Gilkes DM. Detection of Hypoxia in Cancer Models: Significance, Challenges, and Advances. Cells. 2022 Feb 16;11(4):686. doi: 10.3390/cells11040686.

    PMID: 35203334BACKGROUND
  • Gillies RJ, Brown JS, Anderson ARA, Gatenby RA. Eco-evolutionary causes and consequences of temporal changes in intratumoural blood flow. Nat Rev Cancer. 2018 Sep;18(9):576-585. doi: 10.1038/s41568-018-0030-7.

    PMID: 29891961BACKGROUND
  • Wu Q, You L, Nepovimova E, Heger Z, Wu W, Kuca K, Adam V. Hypoxia-inducible factors: master regulators of hypoxic tumor immune escape. J Hematol Oncol. 2022 Jun 3;15(1):77. doi: 10.1186/s13045-022-01292-6.

    PMID: 35659268BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Postop mastectomy pathologic materials

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Associate

Study Record Dates

First Submitted

January 10, 2024

First Posted

March 13, 2024

Study Start

August 1, 2018

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations