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Not yet recruitingNCT07238127Updated Dec 19, 2025

AST/ALT & MPV/Platelets Ratios in Breast Cancer

An observational study in Breast Cancer, AST/ALT Ratio and MPV/Platelets Ratio, sponsored by Assiut University. Not yet recruiting. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
110
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Breast Cancer
  • AST/ALT Ratio
  • MPV/Platelets Ratio

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 110 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

breast cancer patients as cases and healthy people as controls

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. other malignant diseases
  2. male breast cancer
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
110 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07238127
Lead sponsor
Assiut University
Responsible party
Gehad Salah El-Din shaker (Principal investigator, Assiut University) — Principal investigator
First posted
Nov 20, 2025
Start date
Jan 1, 2026 (estimated)
Primary completion
Nov 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Dec 19, 2025

Study contacts

Gehad Salah El- Din Shaker
Contact
ghafez113@gmail.com
20 01007293809

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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