Bladder Urothelial CarcinomaNCT06550947
ALDOA Expression in Bladder Urothelial Carcinoma
An observational study of Bladder Urothelial Carcinoma, run by Assiut University.
Trial summary
1. Study the immunohistochemical expression of ALDOA in bladder urothelial cancer. 2. Correlate between ALDOA expression in specimens and different cilnicopathological factors. 3. Correlate between ALDOA expression and urothelial cancer prognosis and survival. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Urothelial Carcinoma
- What is being tested?
- Immunohistochemistry
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Aug 2025
- 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 fifty 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
- All cases diagnosed as bladder urothelial cancer with known follow-up data and presence of muscle proper detected in the specimens.
Who cannot join
- Subtypes of bladder cancer other than urothelial carcinoma subtype.
- Cases of urothelial carcinoma without known follow up data.
- Cases of urothelial carcinoma without muscle proper detected in the specimen.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Immunohistochemical Expression and Prognostic Significance of ALDOA in Bladder Urothelial Carcinoma.
- Study the immunohistochemical expression of ALDOA in bladder urothelial cancer.
- Correlate between ALDOA expression in specimens and different cilnicopathological factors.
- Correlate between ALDOA expression and urothelial cancer prognosis and survival.
Read the detailed description
Bladder cancer is the 7th most prevalent malignancy and the 13th cause of cancer related death worldwide1. In Egypt, it's the third most common tumor2.
The most common histologic subtype of bladder cancer is urothelial carcinoma3. Bladder cancer is divided according to absence or presence of muscle invasion into non-muscle invasive bladder cancer and muscle invasive bladder cancer 3.
Despite the advance in diagnosis and development of therapeutic options of urothelial cancer, the recurrence and progression rate remains high4.
The conventional histopathological evaluation of urothelial cancer is vital for diagnosis and prediction of patient's prognosis. However, it doesn't fully reflect the biological behavior of the tumor or the clinical outcome of the patient5.
Under hypoxic conditions, cancer cells produce ATP by glycolysis, which provide energy for tumor proliferation and dissemination6,7. Glycolytic enzymes are abnormally activated in cancer cells8,9. Thus, several studies have identified glycolytic enzymes or related metabolic pathways as potential drug targets. One of the typical glycolytic enzymes is Aldolase A (ALDOA) 6 which is the most abundant glycolytic enzyme detected in tumors10.
Several studies have identified ALDOA as an oncogene in different types of malignancy 6,8,10-12. The oncogenic potential of ALDOA contributed to its ability to stimulate DNA synthesis and accelerate S phase in tumor cell cycle6-8.
In addition, studies have shown that ALDOA promotes tumor cell invasion by negative regulation of E-cadherin and by activation of MAPK, AKT and EGFR signaling pathways7,11,13.
Thus, increased expression of ALDOA in tumor predicts a bad prognosis and poor survival of patients13-15.
- Conditions
- Bladder Urothelial Carcinoma
- Being tested
- Immunohistochemistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunohistochemistryGenetic
Immunohistochemical expression of ALDOA in bladder urothelial carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the immunohistochemical expression of ALDOA in bladder urothelial carcinoma.
Microscopic examination of bladder urothelial carcinoma spicemens and staining them with ALDOA marker
Measured: Baseline
Secondary outcomes (1)
Evaluate relation between ALDOA expression and cilnicopathological features and patient survival.
Correlate between ALDOA expression and the different clinicopathological factors of patients and their survival.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Hesham John, Assiut University
- Investigators
- Dalia Elsers, Professor, Study director, Head of Pathology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550947
- Sponsor's protocol ID
- Bladder immunohistochemistry
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistochemical Expression and Prognostic Significance of ALDOA in Bladder Urothelial Carcinoma.
- ClinicalTrials.gov ID
- NCT06550947
- Acronym / sponsor ID
- Bladder immunohistochemistry
- Conditions
- Bladder Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 13 Aug 2024 (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.
- Study the immunohistochemical expression of ALDOA in bladder urothelial cancer.
- Correlate between ALDOA expression in specimens and different cilnicopathological factors.
- Correlate between ALDOA expression and urothelial cancer prognosis and survival.
Detailed description
Bladder cancer is the 7th most prevalent malignancy and the 13th cause of cancer related death worldwide1. In Egypt, it's the third most common tumor2.
The most common histologic subtype of bladder cancer is urothelial carcinoma3. Bladder cancer is divided according to absence or presence of muscle invasion into non-muscle invasive bladder cancer and muscle invasive bladder cancer 3.
Despite the advance in diagnosis and development of therapeutic options of urothelial cancer, the recurrence and progression rate remains high4.
The conventional histopathological evaluation of urothelial cancer is vital for diagnosis and prediction of patient's prognosis. However, it doesn't fully reflect the biological behavior of the tumor or the clinical outcome of the patient5.
Under hypoxic conditions, cancer cells produce ATP by glycolysis, which provide energy for tumor proliferation and dissemination6,7. Glycolytic enzymes are abnormally activated in cancer cells8,9. Thus, several studies have identified glycolytic enzymes or related metabolic pathways as potential drug targets. One of the typical glycolytic enzymes is Aldolase A (ALDOA) 6 which is the most abundant glycolytic enzyme detected in tumors10.
Several studies have identified ALDOA as an oncogene in different types of malignancy 6,8,10-12. The oncogenic potential of ALDOA contributed to its ability to stimulate DNA synthesis and accelerate S phase in tumor cell cycle6-8.
In addition, studies have shown that ALDOA promotes tumor cell invasion by negative regulation of E-cadherin and by activation of MAPK, AKT and EGFR signaling pathways7,11,13.
Thus, increased expression of ALDOA in tumor predicts a bad prognosis and poor survival of patients13-15.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
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 fifty 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)
- All cases diagnosed as bladder urothelial cancer with known follow-up data and presence of muscle proper detected in the specimens.
Key exclusion criteria (3 listed)
- Subtypes of bladder cancer other than urothelial carcinoma subtype.
- Cases of urothelial carcinoma without known follow up data.
- Cases of urothelial carcinoma without muscle proper detected in the specimen.
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 |
|---|---|---|
| ImmunohistochemistryImmunohistochemical expression of ALDOA in bladder urothelial carcinoma | Genetic | – |
Primary outcome
Evaluate the immunohistochemical expression of ALDOA in bladder urothelial carcinoma.
Time frame: Baseline
Microscopic examination of bladder urothelial carcinoma spicemens and staining them with ALDOA marker
1 secondary outcome
Evaluate relation between ALDOA expression and cilnicopathological features and patient survival.
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 13 Aug 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Dalia Elsers, Professor study director
Head of Pathology Department
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder 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 3 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 13 Aug 2024. 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 Merna Hesham John, Demonstrator (+201070019195 ext. +201289824116, mernahesham@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the immunohistochemical expression of ALDOA in bladder urothelial carcinoma. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2024.