Clinical trial NCT06402084: The Relationship Between Fatty Liver and Breast Cancer
Official title: The Relationship Between Fatty Liver and Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: The Relationship Between Fatty Liver and Breast Cancer
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: breast cancer patients will be included,Patients who were recently diagnosed as breast cancer patients will be included,examined and their files will be studied.

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: lipid profile in patients with breast cancer
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.