- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06402084
The Relationship Between Fatty Liver and Breast Cancer
clinicopathological result of a common is (NAFLD) alcoholic fatty liver disease-nNo 30% of -NAFLD affects 20% .not caused by alcohol intake is chronic liver disease thatsuch as conditions spectrum of population and can be characterized by wide general et Chalasani( steatosis by isolated intracellular fat deposition marked noninflammatory .al., 2012)
homeostasis and egulation of hepatic cholesterol NAFLD occurs due to the dysr . NAFLD is liver in triglycerides and free cholesterol, free fatty acids, accumulation ofabdominal and with insulin resistance, diabetes mellitus, metabolic syndrome associatedimplicated in the be can NAFLD that suggested reports the arge number ofL .obesity kidney diseases as well as cancersf cardiovascular, pulmonary, and pathology o .2015) et al., (Arguello
their course of the Patients with breast cancer commonly develop NAFLD during .45.2%-2.3% approximately cancer is disease. The incidence of NAFLD in breast by influenced metabolic profile and is patient's NAFLD seems to be associated with cardiovascular and resistance insulin causingand treatment, breast cancer complications (Lee et al., 2017).
modulators term estrogen inhibition with selective estrogen receptors-Long liver with tamoxifen fatty incidence of The s been reported to cause NAFLD.ha (SERMs)of NAFLD development in impact heT . use an that for aromatase inhibitoruse is higher th et al., (Yang breast cancer patients after hormonal treatment has not yet been elucidated .)6201
main and is aworldwide most common cancer in womenBreast cancer is the decreasing with has been cancer breast from ityortalM .women in death cancer of causeIt is well known time given the advances in screening strategies and adjuvant treatments. incidence of breast cancer is correlated with age and other risk factors such asthat the mutation, family history of )BRCA2( breast cancer gene2 or )BRCA1(gene1breast cancer al.,et Berry( and hormonal factors chest the to breast cancer, therapeutic radiation5).200
Breast cancer is divided according to the hormone receptors into either hormone receptor-positive tumors which are estrogen receptor-positive (ER-positive) and progesterone receptor-positive (PR-positive). These tumors express hormone receptors. This means they have a lot of hormone receptors. Hormone receptor-negative tumors are estrogen receptor-negative (ER-negative) and progesterone receptor-negative (PR-negative). These tumors donot express hormone receptors. This means they have few or no hormone receptors. About 70% to 80% of newly diagnosed breast cancers are hormone receptor- .al., 2017) (Wang et positive
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: samar S Abd El-Rahman, resident
- Phone Number: 01157685509
- Email: samar.saad@med.sohag.edu.eg
Study Contact Backup
- Name: Mahmoud S Abdel Fattah, professor
- Phone Number: 01091055908
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag University Hospital
-
Contact:
- Magdy M Amin, professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 65 years old)-Age (18-1
performance (PS0;full active,noPerformance status < or equal to 2 Patients with-2PS1;strenuous physical activity restricted,fully ambulatory and able to ----restriction.care but unable to carry out any work -PS2;capable of all self-------carry out light work.activities up and about >50% of woking hours)
Exclusion Criteria:
- Patients who had double malignancy.-1
Patients who had severe comorbidities -2
heart failure…..etc,)(pulmonary failure,Renal failure,
Those who declined cancer treatment before completing 85% of the planned dosage -3 hose who are lost during the follow up period.tor
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
group A
cases
|
abdominal ultrasound and lipid profile will be done
Other Names:
|
|
group B
controls
|
abdominal ultrasound and lipid profile will be done
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
lipid profile in patients with breast cancer
Time Frame: 1 year
|
The relationship between Fatty Liver and Breast Cancer by abdominal ultrasound and lipid
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ; American Gastroenterological Association; American Association for the Study of Liver Diseases; American College of Gastroenterologyh. The diagnosis and management of non-alcoholic fatty liver disease: practice guideline by the American Gastroenterological Association, American Association for the Study of Liver Diseases, and American College of Gastroenterology. Gastroenterology. 2012 Jun;142(7):1592-609. doi: 10.1053/j.gastro.2012.04.001. Epub 2012 May 15. No abstract available. Erratum In: Gastroenterology. 2012 Aug;143(2):503.
- Arguello G, Balboa E, Arrese M, Zanlungo S. Recent insights on the role of cholesterol in non-alcoholic fatty liver disease. Biochim Biophys Acta. 2015 Sep;1852(9):1765-78. doi: 10.1016/j.bbadis.2015.05.015. Epub 2015 May 29.
- Yang YJ, Kim KM, An JH, Lee DB, Shim JH, Lim YS, Lee HC, Lee YS, Ahn JH, Jung KH, Kim SB. Clinical significance of fatty liver disease induced by tamoxifen and toremifene in breast cancer patients. Breast. 2016 Aug;28:67-72. doi: 10.1016/j.breast.2016.04.017. Epub 2016 May 27.
- Lee S, Jung Y, Bae Y, Yun SP, Kim S, Jo H, Seo HI. Prevalence and risk factors of nonalcoholic fatty liver disease in breast cancer patients. Tumori. 2017 Mar 24;103(2):187-192. doi: 10.5301/tj.5000536. Epub 2016 Aug 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- Soh-Med-24-04-013MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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