Triple Negative Breast CancerNCT06309459
Carbonic Anhydrase IX Enzyme in Triple Negative Breast Carcinoma
An observational study of Triple Negative Breast Cancer and Carbonic Anhydrase IX, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, Carbonic Anhydrase IX
- What is being tested?
- Carbonic anhydrase staining levels
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 1 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Triple Negative Breast Cancer cases who were operated in Elazığ Fethi Sekin SUAM
Who may be able to join
- Older than 18 years
- Triple-negative mastectomy cases
- Patients whose data can be available
- Patients who were operated in our hospital
Who cannot join
- Younger than 18 years
- Not triple negative mastectomy cases
- Patients with missing data
- Patients who were operated in another hospital
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University
Kahramanmaraş, 46000
About this study
Official title: 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.
Read the 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.
- Being tested
- Carbonic anhydrase staining levels
- Keywords
- Triple negative breast carcinoma, Carbonic anhydrase IX, Treatment effect, Ki67 proliferation index
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbonic anhydrase staining levelsDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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% Receives: Diagnostic Test: Carbonic anhydrase staining levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poor prognostic factors in patients with TNBC
Higher staining CA IX levels (≥ 10%) in TNBC patients' pathological specimens is a poor prognostic factor
Measured: 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
Measured: 2018-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Aug 2018
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Buğra Bozan, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309459
- Sponsor's protocol ID
- IRB 2023/04-34
- Status last verified
- Mar 2024
- First submitted
- 10 Jan 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35933373Sung 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.
PubMed 33538338Yin 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.
PubMed 32517735Warburg 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.
PubMed 19872213Carroll 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.
PubMed 35150959Lee 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.
PubMed 32144406Godet 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.
PubMed 35203334Gillies 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.
PubMed 29891961Wu 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.
PubMed 35659268
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbonic Anhydrase IX Enzyme in Triple Negative Breast Carcinoma: Relationship With Prognostic Factors and Response to Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT06309459
- Acronym / sponsor ID
- IRB 2023/04-34
- Keywords
- Triple negative breast carcinoma, Carbonic anhydrase IX, Treatment effect, Ki67 proliferation index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 13 Mar 2024 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Staining | – | Diagnostic Test: Carbonic anhydrase staining levelsCA 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. |
| High Staining | – | Diagnostic Test: Carbonic anhydrase staining levelsCA IX is a transmembrane protein, it exhibits cytoplasmic membrane staining. Immunohistochemically positive cells were graded as high staining if they constituted ≥ 10% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Triple Negative Breast Cancer cases who were operated in Elazığ Fethi Sekin SUAM
Key inclusion criteria (4 listed)
- Older than 18 years
- Triple-negative mastectomy cases
- Patients whose data can be available
- Patients who were operated in our hospital
Key exclusion criteria (4 listed)
- Younger than 18 years
- Not triple negative mastectomy cases
- Patients with missing data
- Patients who were operated in another hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbonic anhydrase staining levelsCA 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). | Diagnostic test | High Staining, Low Staining |
Primary outcome
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
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
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 13 Mar 2024.
- Background: PubMed 35933373Bakherad 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.
- Background: PubMed 33538338Sung 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.
- Background: PubMed 32517735Yin 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.
- Background: PubMed 19872213Warburg 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.
- Background: PubMed 35150959Carroll 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.
- Background: PubMed 32144406Lee 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.
- Background: PubMed 35203334Godet 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.
- Background: PubMed 29891961Gillies 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.
- Background: PubMed 35659268Wu 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triple Negative Breast Cancer and Carbonic Anhydrase IX, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Poor prognostic factors in patients with TNBC (time frame: 2018-2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06309459, which also lists 9 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 13 Mar 2024.