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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04295967
Other study ID # VM in urothelial carcinoma
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2020
Est. completion date May 2022

Study information

Verified date March 2020
Source Assiut University
Contact Ereny K Louis, demonstrator
Phone +201023720295
Email ereny.kamal14@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, the investigators aim at:

1. Evaluate the presence of vasculogenic mimicry in urothelial carcinomas by CD31-PAS double staining.

2. Correlate the presence of vasculogenic mimicry with the clinicopathologic features as age, sex, TNM stage, pathological grade, recurrence, carcinoma in situ, lymphovascular emboli, lymph node metastasis, necrosis, surgical margin, multifocality and tumor size in urothelial carcinoma.


Description:

Bladder cancer is the ninth most common cancer worldwide which seriously affects human health. In Egypt, it is the third common malignant tumor.

Urothelial carcinoma (UC) is considered the most common histologic type of bladder cancer.

It is well recognized that the biological behavior of several cancers is closely related to their blood supply. Tumor progression and metastasis have been long associated with tumor angiogenesis. However, several studies demonstrated that vascular targeting drugs which induce endothelial cell apoptosis have a little effect. So, it has been suggested that novel tumor microcirculation patterns may exist in these neoplasms.

Vasculogenic mimicry (VM), is a novel tumor microcirculation system. Maniotis et al initially discovered VM in melanoma and defined these channels to be composed of tumor basement membrane lined externally by tumor cells, lacking blood vessel endothelium and containing plasma and red blood cells. So VM can be distinguished using immunohistochemical (IHC) staining and histochemical double staining. VM is CD31- or CD34-negative (endothelial markers) and periodic acid-Schiff (PAS) positive.

Vasculogenic mimicry was detected in several malignant tumors. Several studies reported that VM can promote tumor progression and metastasis and it is positively associated with pathological grade, stage, recurrence and drug resistance. Previous studies which evaluate, the role of VM in urothelial carcinoma yield controversial results. So, the value of VM in urothelial carcinomas and its relation to the clinicopathologic parameters remains to be elucidated.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date May 2022
Est. primary completion date May 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- - Specimens of urothelial carcinoma.

Exclusion Criteria:

- - Any criteria that not fulfill the inclusion criteria such as resected urinary bladder tumors other than urothelial carcinoma.

Study Design


Intervention

Other:
formalin fixed paraffin embedded blocks
The study will be conducted using formalin fixed paraffin embedded blocks of seventy cases of urothelial carcinomas .CD31-PAS dual-staining will be performed to confirm the presence of VM.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Aso Y, Ushiyama T, Suzuki K, Tajima A, Naide Y, Ohshima S, Matsuura O, Fukushima M, Ota K, Ono Y, et al. [Use of VM-26 as a single agent in the treatment of transitional cell carcinoma of the urinary tract]. Nihon Gan Chiryo Gakkai Shi. 1988 May 20;23(5):1046-51. Japanese. — View Citation

Zhou L, Chang Y, Xu L, Hoang ST, Liu Z, Fu Q, Lin Z, Xu J. Prognostic value of vascular mimicry in patients with urothelial carcinoma of the bladder after radical cystectomy. Oncotarget. 2016 Nov 15;7(46):76214-76223. doi: 10.18632/oncotarget.12775. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the presence of vasculogenic mimicry in urothelial carcinomas by CD31-PAS double staining baseline
Secondary Correlate the presence of vasculogenic mimicry with the clinicopathologic features in urothelial carcinoma. baseline
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