Breast CancerNCT07113418
Role of FGF21 in Breast Cancer
An observational study of Breast Cancer, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ELISA
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2025to Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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:
Inclusion Criteria:Female patients admitted at south Egypt cancer institute who diagnosed as breast cancer basedon full clinical, radiological and pathological assays.
-
Exclusion Criteria:Patients diagnosed with other concomitant cancers.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Asmaa Asmaa Mohamed Zahran, Professor contact
About this study
Official title: Role of Fibroblast Growth Factor 21(FGF21) in Breast Cancer
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.
Read the detailed description
Breast cancer is the most common malignant tumor in women, accounting for about 30 %, and its mortality rate is15 % of the incidence rate.
Studies in recent years have shown that the incidence of breast cancer is increasing year by year, which seriously affects Women's quality of life.
Several hormonal. metabolic and inflammatory mechanisms are known to play a role in the development and progression of breast cancer.
Fibroblast growth factor 21 (FGF21) is a protein produced mainly in the liver and regulated by diseases.The elucidation of the endocrine FGF21 signaling pathways in the control of metabolic disease, peroxisome proliferator-activated receptor-α (PPAR-α) which functions in lipid metabolism. However, more data support a versatile role for this molecule acting as a physiologic alert system in several energy homeostasis and their complications has raised great interest and hope in the last year.
Cancer-associated fibroblasts are activated fibroblasts that serve as a key component of the tumor receptors. FGFR1 is often overexpressed in breast and lung cancer, Promoter hypermethylation correlates microenvironment; FGF-19, FGF-21 and FGF-23 are endocrine FGFs that bind to Klotho and FGF with poorer survival of patients.
Clearly, further studies are needed to elucidate the mechanisms behind the increased serum FGF21 levels a high FGF21 secretion by the liver and also by the tumor cells or the stress caused by microenvironment condition that induces an increased FGF21 secretion by mainly the hepatocytes or/and adipocytes in less in cancer patients. It is believed that the elevated FGF21 levels observed in these patients could be due to metabolic disorders. Alternatively, the initiation of the tumor itself could be considered as a stressful degree. A study shows that Circulating FGF-21 level is associated with increased risk of early and late stages of (11)Another study shows that FGF21 is useful as a diagnostic as well as prognostic factor in patients with colorectal carcinogenesis ,supporting a role of inflammation and metabolism atall stages of colorectal carcinogenesis, and suggesting potential use of this biomarker for risk stratification in CRCscreening. endometrioid endometrial carcinoma.
The role of FGF21 in breast cancer and its level is not adequatelyincluded however a study byRanuncolo etal., revealed increased serum level as well astissue expression level of FGF21 in breast cancer.
- Conditions
- Breast Cancer
- Being tested
- ELISA
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients | Female patients admitted at south Egypt cancer institute who diagnosed as breast cancer based on full clinical, radiological and pathological data. Receives: Diagnostic Test: ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum FGF21 level measured by ELISA in breast cancer patients compared to healthy controls at enrollment.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mostafa Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113418
- Sponsor's protocol ID
- FGF21 in breast cancer
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40527315Cymbaluk-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.
PubMed 32570721Ferreira 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.
PubMed 38561089Ewendt 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.
PubMed 33520985Ping 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.
PubMed 33712707Sanchez-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.
PubMed 28502645Gong 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.
PubMed 31024317Falk 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.
PubMed 26870258Llovet 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.
PubMed 30061739Luo 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.
PubMed 24385972
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Fibroblast Growth Factor 21(FGF21) in Breast Cancer
- ClinicalTrials.gov ID
- NCT07113418
- Acronym / sponsor ID
- FGF21 in breast cancer
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer is the most common malignant tumor in women, accounting for about 30 %, and its mortality rate is15 % of the incidence rate.
Studies in recent years have shown that the incidence of breast cancer is increasing year by year, which seriously affects Women's quality of life.
Several hormonal. metabolic and inflammatory mechanisms are known to play a role in the development and progression of breast cancer.
Fibroblast growth factor 21 (FGF21) is a protein produced mainly in the liver and regulated by diseases.The elucidation of the endocrine FGF21 signaling pathways in the control of metabolic disease, peroxisome proliferator-activated receptor-α (PPAR-α) which functions in lipid metabolism. However, more data support a versatile role for this molecule acting as a physiologic alert system in several energy homeostasis and their complications has raised great interest and hope in the last year.
Cancer-associated fibroblasts are activated fibroblasts that serve as a key component of the tumor receptors. FGFR1 is often overexpressed in breast and lung cancer, Promoter hypermethylation correlates microenvironment; FGF-19, FGF-21 and FGF-23 are endocrine FGFs that bind to Klotho and FGF with poorer survival of patients.
Clearly, further studies are needed to elucidate the mechanisms behind the increased serum FGF21 levels a high FGF21 secretion by the liver and also by the tumor cells or the stress caused by microenvironment condition that induces an increased FGF21 secretion by mainly the hepatocytes or/and adipocytes in less in cancer patients. It is believed that the elevated FGF21 levels observed in these patients could be due to metabolic disorders. Alternatively, the initiation of the tumor itself could be considered as a stressful degree. A study shows that Circulating FGF-21 level is associated with increased risk of early and late stages of (11)Another study shows that FGF21 is useful as a diagnostic as well as prognostic factor in patients with colorectal carcinogenesis ,supporting a role of inflammation and metabolism atall stages of colorectal carcinogenesis, and suggesting potential use of this biomarker for risk stratification in CRCscreening. endometrioid endometrial carcinoma.
The role of FGF21 in breast cancer and its level is not adequatelyincluded however a study byRanuncolo etal., revealed increased serum level as well astissue expression level of FGF21 in breast cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients | – | Diagnostic Test: ELISAFemale patients admitted at south Egypt cancer institute who diagnosed as breast cancer based on full clinical, radiological and pathological data. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISAEnzyme-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. | Diagnostic test | Breast cancer patients |
Primary outcome
Serum FGF21 level measured by ELISA in breast cancer patients compared to healthy controls at enrollment.
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Background: PubMed 40527315Gliniak 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.
- Background: PubMed 32570721Cymbaluk-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.
- Background: PubMed 38561089Ferreira 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.
- Background: PubMed 33520985Ewendt 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.
- Background: PubMed 33712707Ping 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.
- Background: PubMed 28502645Sanchez-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.
- Background: PubMed 31024317Gong 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.
- Background: PubMed 26870258Falk 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.
- Background: PubMed 30061739Llovet 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.
- Results publication: PubMed 24385972Luo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asmaa Asmaa Mohamed Zahran, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Asmaa Mostafa Ali, Resident doctor (+201128008966, asmaamustafa751997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum FGF21 level measured by ELISA in breast cancer patients compared to healthy controls at enrollment. (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07113418, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.