NCT06402084

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

May 2, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 2, 2024

Last Update Submit

May 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • lipid profile in patients with breast cancer

    The relationship between Fatty Liver and Breast Cancer by abdominal ultrasound and lipid

    1 year

Study Arms (2)

group A

cases

Diagnostic Test: abdominal ultrasound

group B

controls

Diagnostic Test: abdominal ultrasound

Interventions

abdominal ultrasoundDIAGNOSTIC_TEST

abdominal ultrasound and lipid profile will be done

Also known as: lipid profile
group Agroup B

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 22656328BACKGROUND
  • 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.

    PMID: 26027904BACKGROUND
  • 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.

    PMID: 27240168BACKGROUND
  • 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.

    PMID: 27647227BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

samar S Abd El-Rahman, resident

CONTACT

Mahmoud S Abdel Fattah, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident doctor at tropical medicine and gastroenterology Department at sohag univerisity

Study Record Dates

First Submitted

May 2, 2024

First Posted

May 7, 2024

Study Start

May 2, 2024

Primary Completion

May 5, 2025

Study Completion

May 5, 2025

Last Updated

May 7, 2024

Record last verified: 2024-05

Locations