Breast CancerNCT07238127
AST/ALT & MPV/Platelets Ratios in Breast Cancer
An observational study of Breast Cancer and AST/ALT Ratio, run by Assiut University.
Trial summary
This retrospective study aims to evaluate the association between AST/ALT ratio and MPV/platelets count ratio with breast cancer in a case-control study. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, AST/ALT Ratio, MPV/Platelets Ratio
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: breast cancer patients as cases and healthy people as controls
Who may be able to join
- Newly diagnosed patients of breast cancer admitted to South Egypt Cancer Institute at different stage 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.
About this study
Official title: Role of AST/ALT Ratio & MPV/Platelets Count Ratio in Breast Cancer
This retrospective study aims to evaluate the association between AST/ALT ratio and MPV/platelets count ratio with breast cancer in a case-control study.
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 .
Aspartate aminotransaminase (AST) and alanine aminotransaminase (ALT) are liver enzymes commonly used in clinical laboratory tests. These enzymes released from liver cells into the blood are produced by both malignant and nonmalignant cells.
The AST-ALT ratio, also called the De Ritis ratio, was originally defined by De Ritis in 1957 . Although the De Ritis ratio was first used to identify viral hepatitis and some chronic liver diseases, it has been identified in recent studies as an independent prognostic factor for the prediction of disease stage and patient survival in some malignancies .
Complete blood count (CBC) is a routine test that is frequently requested by physicians to diagnose various diseases, such as anemia, acute infections, bleeding, allergic malignancies, cancers, immune disorder, health screening, and preoperative assessments. It provides critical information about cell types, especially red blood cells (RBC), white blood cells (WBC), and platelets (PLT) . CBC, as a routine and cost-effective test, provides valuable information about various malignancies . Evaluation of the hematological factors is also one of the reliable paraclinical methods to diagnose diseases . Also, hematological parameters have prognosis value in patients with breast cancer . CBC is an essential test for patients with breast cancer before using any treatment .
Thus, considering the importance of hematological parameters in the detection of breast cancer, the aim of this study was to evaluate ALT/AST ratio and MPV/platelets count ratio as useful markers to distinguish between patients with breast cancer and healthy individuals.
- Conditions
- Breast Cancer, AST/ALT Ratio, MPV/Platelets Ratio
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Difference in AST/ALT ratio between breast cancer patients and controls 2. Difference in MPV/Platelet count ratio between breast cancer patients and controls
Comparison of mean AST/ALT ratio and MPV/platelets count ratio between the two groups
Measured: Baseline
Secondary outcomes (1)
1. Diagnostic performance of AST/ALT ratio for distinguishing breast cancer patients from controls 2. Diagnostic performance of MPV/Platelet count ratio for distinguishing breast cancer patients from controls
Sensitivity, specificity and AUC calculated from AST/ALT ratio and MPV/platelets count ratio values
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Salah El-Din shaker, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238127
- Sponsor's protocol ID
- AST/ALT & MPV/platelets ratios
- Status last verified
- Oct 2025
- First submitted
- 16 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Divsalar B, Heydari P, Habibollah G, Tamaddon G. Hematological Parameters Changes in Patients with Breast Cancer. Clin Lab. 2021 Aug 1;67(8). doi: 10.7754/Clin.Lab.2020.201103.
PubMed 34383417
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of AST/ALT Ratio & MPV/Platelets Count Ratio in Breast Cancer
- ClinicalTrials.gov ID
- NCT07238127
- Acronym / sponsor ID
- AST/ALT & MPV/platelets ratios
- Conditions
- Breast Cancer, AST/ALT Ratio, MPV/Platelets Ratio
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Nov 2025 (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.
This retrospective study aims to evaluate the association between AST/ALT ratio and MPV/platelets count ratio with breast cancer in a case-control study.
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 .
Aspartate aminotransaminase (AST) and alanine aminotransaminase (ALT) are liver enzymes commonly used in clinical laboratory tests. These enzymes released from liver cells into the blood are produced by both malignant and nonmalignant cells.
The AST-ALT ratio, also called the De Ritis ratio, was originally defined by De Ritis in 1957 . Although the De Ritis ratio was first used to identify viral hepatitis and some chronic liver diseases, it has been identified in recent studies as an independent prognostic factor for the prediction of disease stage and patient survival in some malignancies .
Complete blood count (CBC) is a routine test that is frequently requested by physicians to diagnose various diseases, such as anemia, acute infections, bleeding, allergic malignancies, cancers, immune disorder, health screening, and preoperative assessments. It provides critical information about cell types, especially red blood cells (RBC), white blood cells (WBC), and platelets (PLT) . CBC, as a routine and cost-effective test, provides valuable information about various malignancies . Evaluation of the hematological factors is also one of the reliable paraclinical methods to diagnose diseases . Also, hematological parameters have prognosis value in patients with breast cancer . CBC is an essential test for patients with breast cancer before using any treatment .
Thus, considering the importance of hematological parameters in the detection of breast cancer, the aim of this study was to evaluate ALT/AST ratio and MPV/platelets count ratio as useful markers to distinguish between patients with breast cancer and healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- breast cancer patients as cases and healthy people as controls
Key inclusion criteria (1 listed)
- Newly diagnosed patients of breast cancer admitted to South Egypt Cancer Institute at different stage of the disease
Key exclusion criteria (2 listed)
- other malignant diseases
- male breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1. Difference in AST/ALT ratio between breast cancer patients and controls 2. Difference in MPV/Platelet count ratio between breast cancer patients and controls
Time frame: Baseline
Comparison of mean AST/ALT ratio and MPV/platelets count ratio between the two groups
1 secondary outcome
1. Diagnostic performance of AST/ALT ratio for distinguishing breast cancer patients from controls 2. Diagnostic performance of MPV/Platelet count ratio for distinguishing breast cancer patients from controls
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 34383417Divsalar B, Heydari P, Habibollah G, Tamaddon G. Hematological Parameters Changes in Patients with Breast Cancer. Clin Lab. 2021 Aug 1;67(8). doi: 10.7754/Clin.Lab.2020.201103.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and AST/ALT Ratio, run by Assiut University.
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 2 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 19 Dec 2025. 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 El- Din Shaker (20 01007293809, ghafez113@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Difference in AST/ALT ratio between breast cancer patients and controls 2. Difference in MPV/Platelet count ratio between breast cancer patients and controls (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 NCT07238127, which also lists 1 linked publication.
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 19 Dec 2025.