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CD155 in Bladder Cancer

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ClinicalTrials.gov Identifier: NCT03789682
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Bo Dai, Fudan University

Brief Summary:
This research is designed to investigate the prognostic and predictive value of CD155 in muscle invasive bladder cancer.

Condition or disease Intervention/treatment
Bladder Cancer Drug: Adjuvant chemotherapy

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Value of CD155 for Survival and Effectiveness of Chemotherapy in Patients With Muscle Invasive Bladder Cancer
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Group/Cohort Intervention/treatment
FUSCC cystectomy cohort
patients underwent cystectomy in Fudan University Shanghai Cancer Center
Drug: Adjuvant chemotherapy
adjuvant chemotherapy using Gemcitabine plus Cisplatin




Primary Outcome Measures :
  1. Recurrence free survival [ Time Frame: 2018.1.1-2023.12.31 ]
    Time to recurrence or metastasis


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2018.1.1-2028.1.1 ]
    Time to death

  2. Benefit from neoadjuvant chemotherapy [ Time Frame: 2018.1.1-2028.1.1 ]
    response to neoadjuvant chemotherapy

  3. Benefit from adjuvant chemotherapy [ Time Frame: 2018.1.1-2028.1.1 ]
    Survival analysis grouped by adjuvant chemotherapy



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with non-metastatic muscle invasive bladder cancer underwent cystectomy in Fudan University Shanghai Cancer Center is included
Criteria

Inclusion Criteria:

  • patients with non-metastatic muscle invasive bladder cancer
  • pathology confirmed urothelial carcinoma
  • underwent cystectomy and pelvic lymph node dissection

Exclusion Criteria:

  • not enough tissue for immunohistochemistry
  • patients with a second neoplasm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789682


Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Dai Bo, MD    +86-21 64175590    16211230020@fudan.edu.cn   
Principal Investigator: Dai Bo, MD         
Sponsors and Collaborators
Fudan University

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Responsible Party: Bo Dai, Department of Urology, Fudan University
ClinicalTrials.gov Identifier: NCT03789682     History of Changes
Other Study ID Numbers: FUSCC-URO1201-2018-1
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases