Clinical Study of Neoadjuvant Therapy Outcome Prediction of Muscle-invasive Bladder Cancer Based on PTC Drug Sensitivity Detection

March 11, 2023 updated by: Shaoxi Niu, Chinese PLA General Hospital
In this study, investigators plan to conduct the 3D in vitro culture PTC drug sensitivity testing of fresh tumor specimen which obtained by endoscopic biopsy or other methods. Through assessing the consistency between the testing results and the patients' neoadjuvant treatment outcomes, they would evaluate the accuracy of PTC drug sensitivity testing and its application value in the individualized precision medicine for muscle-invasive bladder carcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational study. In this study, researchers propose to enroll 40 participants above 18 years of age with muscle-invasive bladder carcinoma, who are going to receive the neoadjuvant therapy before surgery. Collecting fresh tumor samples for PTC drug sensitivity testing, conducting neoadjuvant therapy for the subjects simultaneously. By combining PTC prediction results with the patients' clinical treatment process and medication feedback, researchers could estimate the accuracy of PTC drug sensitivity testing. Completion of this research would provide real-world figures to support for the clinical application for PTC drug sensitivity testing, and a method is going to be established to guide the clinical treatment regimen for patients with muscle-invasive bladder carcinoma.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shaoxi Niu, M.D.&Ph.D.
  • Phone Number: +8613911353443
  • Email: g4niuniu@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Urology patients with muscle-invasive bladder carcinoma above 18 years of age, at Chinese PLA General Hospital

Description

Inclusion Criteria:

  • 1 The lesion of biopsy was diagnosed as muscle-invasive bladder cancer
  • 2 Age ≥ 18 years old, regardless of gender
  • 3 Treatment plan of bladder removal surgery
  • 4 Neoadjuvant therapy before surgery
  • 5 Adequate fresh tumor tissue can be obtained by endoscopic biopsy for PTC drug sensitivity testing
  • 6 ECOG 0-1, expected survival is more than 3 months
  • 7 Normal or stable hepatic, renal, and hematopoietic function
  • 8 Normal or stable blood pressure
  • 9 The subjects are willing to participate, sign an informed consent form, and have good compliance

Exclusion Criteria:

  • 1 Patients with incomplete clinical data
  • 2 Central nervous system metastasis
  • 3 The presence of other malignant diseases was discovered during treatment, which is going to interfere the study
  • 4 Researchers believe that the patient is not suitable for participation after comprehensive evaluation
  • 5 Refuse the treatment or follow-up plans

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case Group
Participants who were diagnosed as MIBC and plan to receive neoadjuvant therapy before the surgery, above 18 years of age, regardless of gender
Diagnostic test: Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing
Conducting the neoadjuvant therapy of FDA-approved drugs for patients with muscle-invasive bladder carcinoma, culturing the patient-derived tumor-like cell clusters for drug sensitivity testing simultaneously, then assess the accuracy of the diagnostic test by combination and analysis of these results

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response (CR)
Time Frame: 3 months
Disappearance of all target lesions. Any pathological lymph nodes（whether target or non-target）must have reduction in short axis to <10 mm. Length is measured in millimeters, refers to RECIST 1.1.
3 months
Partial Response (PR)
Time Frame: 3 months
At least a 30％ decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Length is measured in millimeters, refers to RECIST 1.1.
3 months
Progressive Disease (PD)
Time Frame: 3 months
At least a 20％ increase in the sum of diameters of target lesions, taking as reference the smallest sum on study（this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20％, the sum must also demonstrate an absolute increase of at least 5 mm.（the appearance of one or more new lesions is also considered progression). Length is measured in millimeters, refers to RECIST 1.1.
3 months
Stable Disease (SD)
Time Frame: 3 months
Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Length is measured in millimeters, refers to RECIST 1.1.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Collaborators

Beijing GeneX Health Technology Co., Ltd

Investigators

  • Principal Investigator: Xu Zhang, M.D.&Ph.D., Chinese PLA General Hospital
  • Principal Investigator: Hongzhao Li, M.D.&Ph.D., Chinese PLA General Hospital
  • Principal Investigator: Shaoxi Niu, M.D.&Ph.D., Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2022

Primary Completion (Anticipated)

December 8, 2023

Study Completion (Anticipated)

December 8, 2024

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

March 11, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 11, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2022-714-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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