NCT07113418

Brief Summary

The present study aims to evaluate the serum level of FGF-21 in patients with breast cancer and its correlation with clinical, laboratory, and pathological data.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet 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

Study Progress55%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

July 22, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

July 22, 2025

Last Update Submit

August 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serum FGF21 level measured by ELISA in breast cancer patients compared to healthy controls at enrollment.

    At enrollment

Study Arms (1)

Breast cancer patients

Female patients admitted at south Egypt cancer institute who diagnosed as breast cancer based on full clinical, radiological and pathological data.

Diagnostic Test: ELISA

Interventions

ELISADIAGNOSTIC_TEST

Enzyme-Linked Immunosorbent Assay. It's a lab technique used to detect and measure specific proteins like antibodies or antigens in a biological sample using enzyme-linked antibodies. When a substrate is added, the enzyme causes a color change, which makes it easy to measure the result accurately.

Breast cancer patients

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients admitted at south Egypt cancer institute who diagnosed as breast cancer basedon full clinical, radiological and pathological assays. b. Exclusion criteria:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit university ( South Egypt Cancer Institute )

Asyut, Egypt

Location

Related Publications (10)

  • Gliniak CM, Gordillo R, Youm YH, Lin Q, Crewe C, Zhang Z, Field BC, Fujikawa T, Virostek M, Zhao S, Zhu Y, Rosen CJ, Horvath TL, Dixit VD, Scherer PE. FGF21 promotes longevity in diet-induced obesity through metabolic benefits independent of growth suppression. Cell Metab. 2025 Jul 1;37(7):1547-1567.e6. doi: 10.1016/j.cmet.2025.05.011. Epub 2025 Jun 16.

    PMID: 40527315BACKGROUND
  • Cymbaluk-Ploska A, Gargulinska P, Chudecka-Glaz A, Kwiatkowski S, Pius-Sadowska E, Machalinski B. The Suitability of FGF21 and FGF23 as New Biomarkers in Endometrial Cancer Patients. Diagnostics (Basel). 2020 Jun 18;10(6):414. doi: 10.3390/diagnostics10060414.

    PMID: 32570721BACKGROUND
  • Ferreira Almeida C, Correia-da-Silva G, Teixeira N, Amaral C. Influence of tumor microenvironment on the different breast cancer subtypes and applied therapies. Biochem Pharmacol. 2024 May;223:116178. doi: 10.1016/j.bcp.2024.116178. Epub 2024 Mar 30.

    PMID: 38561089BACKGROUND
  • Ewendt F, Feger M, Foller M. Role of Fibroblast Growth Factor 23 (FGF23) and alphaKlotho in Cancer. Front Cell Dev Biol. 2021 Jan 14;8:601006. doi: 10.3389/fcell.2020.601006. eCollection 2020.

    PMID: 33520985BACKGROUND
  • Ping Q, Yan R, Cheng X, Wang W, Zhong Y, Hou Z, Shi Y, Wang C, Li R. Cancer-associated fibroblasts: overview, progress, challenges, and directions. Cancer Gene Ther. 2021 Sep;28(9):984-999. doi: 10.1038/s41417-021-00318-4. Epub 2021 Mar 12.

    PMID: 33712707BACKGROUND
  • Sanchez-Hurtado LA, Tejeda-Huezo BC, Gomez-Flores SS, Esquivel-Chavez A, Cano-Oviedo AA, Baltazar-Torres JA. Elderly patients in a Mexican intensive care unit: A retrospective analysis. Med Intensiva (Engl Ed). 2018 May;42(4):258-260. doi: 10.1016/j.medin.2017.03.006. Epub 2017 May 12. No abstract available. English, Spanish.

    PMID: 28502645BACKGROUND
  • Gong X, Xiong H, Liu S, Liu Y, Yin L, Tu C, Wang H, Zhao Z, Chen W, Mei Z. Qingpeng Ointment Ameliorates Inflammatory Responses and Dysregulation of Itch-Related Molecules for Its Antipruritic Effects in Experimental Allergic Contact Dermatitis. Front Pharmacol. 2019 Apr 9;10:354. doi: 10.3389/fphar.2019.00354. eCollection 2019.

    PMID: 31024317BACKGROUND
  • Luo Y, McKeehan WL. Stressed Liver and Muscle Call on Adipocytes with FGF21. Front Endocrinol (Lausanne). 2013 Dec 18;4:194. doi: 10.3389/fendo.2013.00194.

    PMID: 24385972BACKGROUND
  • Falk Libby E, Liu J, Li YI, Lewis MJ, Demark-Wahnefried W, Hurst DR. Globular adiponectin enhances invasion in human breast cancer cells. Oncol Lett. 2016 Jan;11(1):633-641. doi: 10.3892/ol.2015.3965. Epub 2015 Nov 24.

    PMID: 26870258BACKGROUND
  • Llovet JM, Montal R, Sia D, Finn RS. Molecular therapies and precision medicine for hepatocellular carcinoma. Nat Rev Clin Oncol. 2018 Oct;15(10):599-616. doi: 10.1038/s41571-018-0073-4.

    PMID: 30061739BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Asmaa Asmaa Mostafa Ali, Resident doctor

CONTACT

Asmaa Asmaa Mohamed Zahran, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctors

Study Record Dates

First Submitted

July 22, 2025

First Posted

August 8, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 8, 2025

Record last verified: 2025-08

Locations