Bladder Cancer Patients Candidate for Radical CystectomyNCT04502498
Preoperative Subclinical DVT Screening in Locally Advanced Bladder Cancer Patients Candidate for Radical Cystectomy.
An observational study of Bladder Cancer Patients Candidate for Radical Cystectomy, run by Kasr El Aini Hospital.
Trial summary
Preoperative subclinical DVT screening in locally advanced bladder cancer patients candidate for radical cystectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer Patients Candidate for Radical Cystectomy
- What is being tested?
- Lower limb duplex & doppler
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Oct 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Locally advanced Bladder cancer patients candidate for radical cystectomy and with no symptoms of DVT
Who may be able to join
- any age
- Any sex
- Muscle invasive bladder cancer local advanced patients candidate for radical cystectomy
Who cannot join
- Unfit patients
- any contraindication for surgery
- obese
- coagulopathy
- bedridden
About this study
Official title: Preoperative Detection of Subclinical Lower Limb Deep Venous Thrombosis in Locally Advanced Bladder Cancer Patients Candidate for Radical Cystectomy
Preoperative subclinical DVT screening in locally advanced bladder cancer patients candidate for radical cystectomy.
Read the detailed description
60 patient with local advanced bladder cancer are subjected to preoperative lower limb duplex within 1 week preoperative to radical cystectomy
- Being tested
- Lower limb duplex & doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower limb duplex & dopplerDiagnostic test
Lower limb duplex and doppler one week before radical cystectomy
| Study group | Role | What they receive |
|---|---|---|
| 60 patients with local advanced bladder cancer | Local advanced bladder cancer patients candidate for radical cystectomy Receives: Diagnostic Test: Lower limb duplex & doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative subclinical DVT
Asymptomatic patients candidate for radical cystectomy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Cancer Patients Candidate for Radical CystectomyStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samer Morsy, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502498
- Sponsor's protocol ID
- Cairo University Hospital
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Detection of Subclinical Lower Limb Deep Venous Thrombosis in Locally Advanced Bladder Cancer Patients Candidate for Radical Cystectomy
- ClinicalTrials.gov ID
- NCT04502498
- Acronym / sponsor ID
- Cairo University Hospital
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 6 Aug 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.
Preoperative subclinical DVT screening in locally advanced bladder cancer patients candidate for radical cystectomy.
Detailed description
60 patient with local advanced bladder cancer are subjected to preoperative lower limb duplex within 1 week preoperative to radical cystectomy
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 60 patients with local advanced bladder cancer | – | Diagnostic Test: Lower limb duplex & dopplerLocal advanced bladder cancer patients candidate for radical cystectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Locally advanced Bladder cancer patients candidate for radical cystectomy and with no symptoms of DVT
Key inclusion criteria (3 listed)
- any age
- Any sex
- Muscle invasive bladder cancer local advanced patients candidate for radical cystectomy
Key exclusion criteria (5 listed)
- Unfit patients
- any contraindication for surgery
- obese
- coagulopathy
- bedridden
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 |
|---|---|---|
| Lower limb duplex & dopplerLower limb duplex and doppler one week before radical cystectomy | Diagnostic test | 60 patients with local advanced bladder cancer |
Primary outcome
Preoperative subclinical DVT
Time frame: 6 months
Asymptomatic patients candidate for radical cystectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer Patients Candidate for Radical Cystectomy, run by Kasr El Aini Hospital.
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 3 inclusion and 5 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 10 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative subclinical DVT (time frame: 6 months). 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 10 Aug 2020.