- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07238127
AST/ALT & MPV/Platelets Ratios in Breast Cancer
Role of AST/ALT Ratio & MPV/Platelets Count Ratio in Breast Cancer
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gehad Salah El- Din Shaker
- Phone Number: 20 01007293809
- Email: ghafez113@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Newly diagnosed patients of breast cancer admitted to South Egypt Cancer Institute at different stage of the disease
Exclusion Criteria:
- other malignant diseases
- male breast cancer
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Sensitivity, specificity and AUC calculated from AST/ALT ratio and MPV/platelets count ratio values
|
baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AST/ALT & MPV/platelets ratios
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedInflammatory Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage IIIB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast CancerUnited States
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
University of Colorado, DenverCompletedStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast CancerUnited States
-
National Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerCanada
-
Mayo ClinicMarker Therapeutics, Inc.CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of Central FloridaFlorida Department of HealthRecruitingBreast Cancer | Breast Cancer Female | Breast Cancer Diagnosis | Breast Cancer Survivors | Breast Cancer Detection | Breast Cancer AwarenessUnited States