Urothelial CarcinomaNCT04295967
Vasculogenic Mimicry in Urothelial Carcinoma
An observational study of Urothelial Carcinoma, run by Assiut University.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- formalin fixed paraffin embedded blocks
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- May 2020to May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- Child, Adult, Older adult
Study population: The study will be conducted using formalin fixed paraffin embedded blocks of sixty cases of urothelial carcinomas . These blocks will be obtained from laboratory archives of the Pathology Department, Assiut University Hospital, Faculty of Medicine. Clinical data for this study will be obtained from laboratory archives of the pathology department, Assiut University Hospital, Assiut University.
Who may be able to join
- - Specimens of urothelial carcinoma.
Who cannot join
- - Any criteria that not fulfill the inclusion criteria such as resected urinary bladder tumors other than urothelial carcinoma.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Vasculogenic Mimicry in Urothelial Carcinoma and Its Association With Clinicopathologic Features
In this study, the investigators aim at:
- Evaluate the presence of vasculogenic mimicry in urothelial carcinomas by CD31-PAS double staining.
- 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.
Read the detailed 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.
- Conditions
- Urothelial Carcinoma
- Being tested
- formalin fixed paraffin embedded blocks
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
formalin fixed paraffin embedded blocksOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | presence of recurrence of urothelial carcinoma Receives: Other: formalin fixed paraffin embedded blocks | |
| 2 | absence of recurrence of urothelial carcinoma Receives: Other: formalin fixed paraffin embedded blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the presence of vasculogenic mimicry in urothelial carcinomas by CD31-PAS double staining
Measured: baseline
Secondary outcomes (1)
Correlate the presence of vasculogenic mimicry with the clinicopathologic features in urothelial carcinoma.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study startMay 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ereny Kamal Louis, Assiut University
- Investigators
- Abeer R Mohamed, professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295967
- Sponsor's protocol ID
- VM in urothelial carcinoma
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27776348Aso 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. No abstract available. Japanese.
PubMed 3418215
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasculogenic Mimicry in Urothelial Carcinoma and Its Association With Clinicopathologic Features
- ClinicalTrials.gov ID
- NCT04295967
- Acronym / sponsor ID
- VM in urothelial carcinoma
- Conditions
- Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 5 Mar 2020 (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.
In this study, the investigators aim at:
- Evaluate the presence of vasculogenic mimicry in urothelial carcinomas by CD31-PAS double staining.
- 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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: formalin fixed paraffin embedded blockspresence of recurrence of urothelial carcinoma |
| 2 | – | Other: formalin fixed paraffin embedded blocksabsence of recurrence of urothelial carcinoma |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted using formalin fixed paraffin embedded blocks of sixty cases of urothelial carcinomas . These blocks will be obtained from laboratory archives of the Pathology Department, Assiut University Hospital, Faculty of Medicine. Clinical data for this study will be obtained from laboratory archives of the pathology department, Assiut University Hospital, Assiut University.
Key inclusion criteria (1 listed)
- - Specimens of urothelial carcinoma.
Key exclusion criteria (1 listed)
- - Any criteria that not fulfill the inclusion criteria such as resected urinary bladder tumors other than urothelial carcinoma.
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 |
|---|---|---|
| formalin fixed paraffin embedded blocksThe 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. | Other | 1, 2 |
Primary outcome
Evaluate the presence of vasculogenic mimicry in urothelial carcinomas by CD31-PAS double staining
Time frame: baseline
1 secondary outcome
Correlate the presence of vasculogenic mimicry with the clinicopathologic features in urothelial carcinoma.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Background: PubMed 27776348Zhou 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.
- Background: PubMed 3418215Aso 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. No abstract available. Japanese.
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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. This study is not recruiting at the moment.
Abeer R Mohamed, professor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ereny K Louis, demonstrator (+201023720295, ereny.kamal14@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the presence of vasculogenic mimicry in urothelial carcinomas by CD31-PAS double staining (time frame: baseline). 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 NCT04295967, which also lists 2 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 5 Mar 2020.