Clinical trial · Observational
The Role of Fibroblast Activation in Uterine Fibroid
A Novel Insight Into the Role of Fibroblast Activation and Autophagy in Uterine Fibroid
NCT03444987CI-TRIAL-00049967completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Uterine fibroids (UFs), also called uterine leiomyomas or myomas, are steroid hormone-responsive, benign tumors of the smooth muscle compartment (myometrium) of the uterus. They are the most common neoplasm affecting women in their reproductive age. It is estimated that up to 77% of women develop UF in their life. UFs are one of the leading causes of hospitalisations for gynaecological disorders and are the most frequent reason for hysterectomy. According to relevant literature, 40%-60% of all the hysterectomies performed are due to the presence of UFs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Measurement of protein expression in tissues. | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- patients group
- description
- include 35 pre-menopausal women (age ˂ 50 years) enrolled to undergo hysterectomy for symptomatic UF at the women health hospitals, Assiut University. * The protein expression of the followings markers will be estimated in tumor tissue samples: 1. Fibroblast activation protein (FAP) will be measured by quantitative real time polymerase chain reaction qRTPCR (mRNA level) and ELISA (protein level). 2. Autophagy markers level (LC3 and p62) will be measured by qRTPCR (mRNA level) and by immunohistochemical analysis. 3. Phosphorylated protein kinase B (pAKT ) by ELISA (protein level). analysis. 4. Markers of oxidative stress (Malondialdehyde as lipid peroxide) by a colorimetric method. 5. Reduced glutathione, an antioxidant marker by a colorimetric method .
- interventionNames
- Genetic: Measurement of protein expression in tissues.
- label
- Control group
- description
- include 35 normal myometrial tissue samples obtained 1 cm away from the fibroid capsule from the same patients. * The protein expression followings markers will be estimated in normal myometrial tissue samples 1. Fibroblast activation protein (FAP) will be measured by quantitative real time polymerase chain reaction qRTPCR (mRNA level) and ELISA (protein level). 2. Autophagy markers level (LC3 and p62) will be measured by qRTPCR (mRNA level) and by immunohistochemical analysis. 3. Phosphorylated protein kinase B (pAKT) by ELISA (protein level). 4. Markers of oxidative stress (Malondialdehyde as lipid peroxide) by a colorimetric method. 5. Reduced glutathione, an antioxidant marker by a colorimetric method .
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: i. Premenopausal women (age ˂ 50) with uterine fibroids who are diagnosed through clinical gynecological, ultrasound and other auxiliary examinations. ii. Patients who exhibit a normal coagulation function. Exclusion Criteria * i. Patients who have a previous history of myomectomy or with ovarian malignancy and borderline tumors ii. Patients who are subsequently diagnosed with uterine adenomyosis. iii. Pregnant women. iv. Patients who receive hormonal treatment within three months before surgery. v. Patients with history of coronary artery disease, hypertension, liver cirrhosis or hematologic disorders.
References
Publications (8)
- BACKGROUNDMcWilliams MM, Chennathukuzhi VM. Recent Advances in Uterine Fibroid Etiology. Semin Reprod Med. 2017 Mar;35(2):181-189. doi: 10.1055/s-0037-1599090. Epub 2017 Mar 9. PMID 28278535
- BACKGROUNDMoore AB, Yu L, Swartz CD, Zheng X, Wang L, Castro L, Kissling GE, Walmer DK, Robboy SJ, Dixon D. Human uterine leiomyoma-derived fibroblasts stimulate uterine leiomyoma cell proliferation and collagen type I production, and activate RTKs and TGF beta receptor signaling in coculture. Cell Commun Signal. 2010 Jun 10;8:10. doi: 10.1186/1478-811X-8-10. PMID 20537183
- BACKGROUNDRasanen K, Vaheri A. Activation of fibroblasts in cancer stroma. Exp Cell Res. 2010 Oct 15;316(17):2713-22. doi: 10.1016/j.yexcr.2010.04.032. Epub 2010 May 6. PMID 20451516
- BACKGROUNDWang H, Wu Q, Liu Z, Luo X, Fan Y, Liu Y, Zhang Y, Hua S, Fu Q, Zhao M, Chen Y, Fang W, Lv X. Downregulation of FAP suppresses cell proliferation and metastasis through PTEN/PI3K/AKT and Ras-ERK signaling in oral squamous cell carcinoma. Cell Death Dis. 2014 Apr 10;5(4):e1155. doi: 10.1038/cddis.2014.122. PMID 24722280
- BACKGROUNDIslam MS, Ciavattini A, Petraglia F, Castellucci M, Ciarmela P. Extracellular matrix in uterine leiomyoma pathogenesis: a potential target for future therapeutics. Hum Reprod Update. 2018 Jan 1;24(1):59-85. doi: 10.1093/humupd/dmx032. PMID 29186429
- BACKGROUNDLuo N, Guan Q, Zheng L, Qu X, Dai H, Cheng Z. Estrogen-mediated activation of fibroblasts and its effects on the fibroid cell proliferation. Transl Res. 2014 Mar;163(3):232-41. doi: 10.1016/j.trsl.2013.11.008. Epub 2013 Nov 20. PMID 24316382
- BACKGROUNDBainbridge TW, Dunshee DR, Kljavin NM, Skelton NJ, Sonoda J, Ernst JA. Selective Homogeneous Assay for Circulating Endopeptidase Fibroblast Activation Protein (FAP). Sci Rep. 2017 Oct 2;7(1):12524. doi: 10.1038/s41598-017-12900-8.