AzTrials
AzTrials

Breast CancerNCT06195371

Impact of CASP3 Gene in Chemoresistance

An observational study of Breast Cancer, run by Gehad Salah El-Din shaker.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

1. This study aims to evaluate the abnormalities of CASP3 gene in chemo resistance in breast cancer by FISH technique. evaluate the abnormalities of CASP3 gene in chemo resistance in breast cancer by FISH technique. 2. Detect CASP3 gene abnormality relation to survival, chemoresponse \& chemoresistance. 3. Read more about this study

Who is it for?
Ages 15 to 75 years, women only
Conditions the study is for
Breast Cancer
How many people
60 participants
Where
No sites listed yet
Study dates
1 May 2024to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 15 to 75 years
  • Women only
  • Child, Adult, Older adult

Study population: female patients with breast cancer

Who may be able to join

  • Newly diagnosed patients of breast cancer admitted to South Egypt Cancer Institute at different stages of the disease

Who cannot join

  • Other malignant diseases-Male breast cancer .

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Gehad Salah E-Din Shaker contact

01007293809

ghafez113@gmail.com

About this study

Official title: The Impact of CASP3 Gene in Chemoresistant Breast Cancer

  1. This study aims to evaluate the abnormalities of CASP3 gene in chemo resistance in breast cancer by FISH technique. evaluate the abnormalities of CASP3 gene in chemo resistance in breast cancer by FISH technique.
  2. Detect CASP3 gene abnormality relation to survival, chemoresponse \& chemoresistance.
  3. Correlate CASP3 gene abnormalities with available clinicopathological data of breast cancer patients.
Read the detailed description

Breast cancer (BC) is the most common malignant tumor in women and the biggest threat to the health of women worldwide. Breast cancer represents a significant global health challenge: it is the most commonly diagnosed cancer in the world with an estimated 2.26 million cases recorded in 2020. Breast cancer is rarely seen in males. The incidence of breast cancer rises rapidly over the years, ranking as the first common cancer among females worldwide, and thus posing a considerable threat to female health. Breast cancer is the leading cause of cancer mortality among females. Although historically considered to be a disease of largely developed countries, over half of breast cancer diagnoses and two-thirds of breast cancer related deaths occurred in the less developed regions of the world in 2020.Being a highly prevalent cancer type, breast cancer is observed in both developing and developed countries with different causes and factors of progression. Adopting new life styles, industrialization, globalization, increased life expectancy, pollution etc are the leading causes of cancer. According to 2018 statistics, every year around 1.2 million new cases of breast cancer were diagnosed. The GLOBACON report of 2018 concluded that breast cancer was the most frequently identified cancer type and leading cause of cancer related death in majority of countries. Major part of breast related cancer is linked with the expression of estrogen receptors and their treatment is related with the disease prognosis. The rate of breast cancer mortality can be reduced down to a limit by early diagnosis; timely treatment and management . The commonly used chemotherapeutic drugs include doxorubicin (DOX), paclitaxel and cyclophosphamide. However, the efficiency of chemotherapy is greatly limited by primary and acquired drug resistance . Chemotherapy is widely accepted as traditional treatment method in spite of the obstacle of chemotherapy resistance. The important mechanisms that may lead to drug resistance include alteration in expression of ABC transporters gene family, damage of topoisomerase enzyme, mutation in DNA repair genes, induced apoptosis by genetic imbalance and alteration in signalling pathways of NF alpha etc. All these worsen the condition of breast cancer making chemotherapy a failure in most cases. According to Yaghoubi et al., 2015, the cells which already acquired drug resistance show cross resistance to anti proliferative nature of anti-oestrogen drugs which have crucial role in breast cancer treatment .Caspase-3, a cysteine-aspartic acid protease, has recently attracted much attention . Caspase-3 is a protein (also called CPP32 or apopain), encoded by the CASP3 gene; which is located in the 4q34 with size 2635 bp. It mediates apoptosis in response to chemotherapy, but losing caspase 3 activity causes cell survival and induces drug resistance through apoptotic pathway in breast cancer .Caspase-3 has been identified as a key mediator of apoptosis, activated in apoptotic cells by both extrinsic (death ligands) and intrinsic (mitochondrial) pathways. It also has several nonapoptotic functions such as involving in tissue differentiation, regeneration, and neural development. Nonconforming activation of caspase-3 can lead to tumorigenesis instead of inducing the programmed cell death.Recent progress in caspase research indicates that caspases-3 is a prominent enzyme not only in apoptotic flux but also in nonapoptotic processes such as tissue differentiation, tissue regeneration, and neural development.

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. - Evaluation of casp3 gene abnormalities by fluorescence in situ hybridization in patients with breast cancer

    Evaluation of casp3 gene abnormalities by fluorescence in situ hybridization in patients with breast cancer

    Measured: baseline

Secondary outcomes (1)

  1. - correlation between casp3 gene and response to Chemotherapy.

    correlation between casp3 gene and response to Chemotherapy.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Cross-sectional
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06195371
Sponsor's protocol ID
CASP3 gene in breast cancer
Status last verified
Oct 2023
First submitted
23 Dec 2023
Last updated
28 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fu W, Song J, Li H. Breviscapine reverses doxorubicin resistance in breast cancer and its related mechanisms. Thorac Cancer. 2023 Sep;14(27):2785-2792. doi: 10.1111/1759-7714.15072. Epub 2023 Aug 16.

    PubMed 37584258

  • Wilkinson L, Gathani T. Understanding breast cancer as a global health concern. Br J Radiol. 2022 Feb 1;95(1130):20211033. doi: 10.1259/bjr.20211033. Epub 2021 Dec 14.

    PubMed 34905391

  • Xu F, Xia T, Xu QT, Zhang X, Huang YZ, Sun X, Shi L, Zhou XJ, Wei JF, Ding Q. RBMS2 Chemosensitizes Breast Cancer Cells to Doxorubicin by Regulating BMF Expression. Int J Biol Sci. 2022 Feb 7;18(4):1724-1736. doi: 10.7150/ijbs.66480. eCollection 2022.

    PubMed 35280673

  • Yaghoubi A, Ghojazadeh M, Abolhasani S, Alikhah H, Khaki-Khatibi F. Correlation of Serum Levels of Vitronectin, Malondialdehyde and Hs- CRP With Disease Severity in Coronary Artery Disease. J Cardiovasc Thorac Res. 2015;7(3):113-7. doi: 10.15171/jcvtr.2015.24.

    PubMed 26430499

  • Asadi M, Taghizadeh S, Kaviani E, Vakili O, Taheri-Anganeh M, Tahamtan M, Savardashtaki A. Caspase-3: Structure, function, and biotechnological aspects. Biotechnol Appl Biochem. 2022 Aug;69(4):1633-1645. doi: 10.1002/bab.2233. Epub 2021 Aug 22.

    PubMed 34342377

  • Jakubowska K, Guzinska-Ustymowicz K, Famulski W, Cepowicz D, Jagodzinska D, Pryczynicz A. Reduced expression of caspase-8 and cleaved caspase-3 in pancreatic ductal adenocarcinoma cells. Oncol Lett. 2016 Mar;11(3):1879-1884. doi: 10.3892/ol.2016.4125. Epub 2016 Jan 19.

    PubMed 26998093

  • Shalini S, Dorstyn L, Dawar S, Kumar S. Old, new and emerging functions of caspases. Cell Death Differ. 2015 Apr;22(4):526-39. doi: 10.1038/cdd.2014.216. Epub 2014 Dec 19.

    PubMed 25526085

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Gehad Salah El-Din shaker.

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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gehad Salah E-Din Shaker (01007293809, ghafez113@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

- Evaluation of casp3 gene abnormalities by fluorescence in situ hybridization in patients with breast cancer (time frame: baseline). 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 NCT06195371, which also lists 7 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 28 Feb 2024.

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