Bladder CancerNCT03789682
CD155 in Bladder Cancer
An observational study of Bladder Cancer, run by Fudan University at 1 site in China.
Trial summary
This research is designed to investigate the prognostic and predictive value of CD155 in muscle invasive bladder cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Adjuvant chemotherapy
- How many people
- 151 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with non-metastatic muscle invasive bladder cancer underwent cystectomy in Fudan University Shanghai Cancer Center is included
Who may be able to join
- patients with non-metastatic muscle invasive bladder cancer
- pathology confirmed urothelial carcinoma
- underwent cystectomy and pelvic lymph node dissection
Who cannot join
- not enough tissue for immunohistochemistry
- patients with a second neoplasm
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Predictive Value of CD155 for Survival and Effectiveness of Chemotherapy in Patients With Muscle Invasive Bladder Cancer
This research is designed to investigate the prognostic and predictive value of CD155 in muscle invasive bladder cancer.
- Conditions
- Bladder Cancer
- Being tested
- Adjuvant chemotherapy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant chemotherapyDrug
adjuvant chemotherapy using Gemcitabine plus Cisplatin
| Study group | Role | What they receive |
|---|---|---|
| FUSCC cystectomy cohort | patients underwent cystectomy in Fudan University Shanghai Cancer Center Receives: Drug: Adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival
Time to recurrence or metastasis
Measured: 2018.1.1-2023.12.31
Secondary outcomes (3)
Overall survival
Time to death
Measured: 2018.1.1-2028.1.1
Benefit from neoadjuvant chemotherapy
response to neoadjuvant chemotherapy
Measured: 2018.1.1-2028.1.1
Benefit from adjuvant chemotherapy
Survival analysis grouped by adjuvant chemotherapy
Measured: 2018.1.1-2028.1.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2023
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Dai, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789682
- Sponsor's protocol ID
- FUSCC-URO1201-2018-1
- Status last verified
- Apr 2025
- First submitted
- 27 Dec 2018
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of CD155 for Survival and Effectiveness of Chemotherapy in Patients With Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT03789682
- Acronym / sponsor ID
- FUSCC-URO1201-2018-1
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 28 Dec 2018 (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.
This research is designed to investigate the prognostic and predictive value of CD155 in muscle invasive bladder cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FUSCC cystectomy cohort | – | Drug: Adjuvant chemotherapypatients underwent cystectomy in Fudan University Shanghai Cancer Center |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with non-metastatic muscle invasive bladder cancer underwent cystectomy in Fudan University Shanghai Cancer Center is included
Key inclusion criteria (3 listed)
- patients with non-metastatic muscle invasive bladder cancer
- pathology confirmed urothelial carcinoma
- underwent cystectomy and pelvic lymph node dissection
Key exclusion criteria (2 listed)
- not enough tissue for immunohistochemistry
- patients with a second neoplasm
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 |
|---|---|---|
| Adjuvant chemotherapyadjuvant chemotherapy using Gemcitabine plus Cisplatin | Drug | FUSCC cystectomy cohort |
Primary outcome
Recurrence free survival
Time frame: 2018.1.1-2023.12.31
Time to recurrence or metastasis
3 secondary outcomes
Overall survival
Time frame: 2018.1.1-2028.1.1
Benefit from neoadjuvant chemotherapy
Time frame: 2018.1.1-2028.1.1
Benefit from adjuvant chemotherapy
Time frame: 2018.1.1-2028.1.1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Fudan University at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrence free survival (time frame: 2018.1.1-2023.12.31). 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 16 Apr 2025.