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

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05767528
Collaborator
Beijing GeneX Health Technology Co., Ltd (Other)
40
Enrollment
1
Location
24
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing

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 Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Clinical Study of Neoadjuvant Therapy Outcome Prediction of Muscle-invasive Bladder Cancer Based on PTC Drug Sensitivity Detection
Actual Study Start Date :
Dec 8, 2022
Anticipated Primary Completion Date :
Dec 8, 2023
Anticipated Study Completion Date :
Dec 8, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Complete Response (CR) [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.

  2. Partial Response (PR) [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. Progressive Disease (PD) [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.

  4. Stable Disease (SD) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chinese PLA General Hospital Beijing Beijing China

Sponsors and Collaborators

  • Chinese PLA General Hospital
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shaoxi Niu, Chinese People's Liberation Army (PLA) General Hospital, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT05767528
Other Study ID Numbers:
  • S2022-714-01
First Posted:
Mar 14, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Shaoxi Niu, Chinese People's Liberation Army (PLA) General Hospital, Chinese PLA General Hospital
Muscle-Invasive Bladder Carcinoma (MIBC)
Patient-derived tumor-like cell clusters (PTC)
Additional relevant MeSH terms:
Urinary Bladder Neoplasms

Study Results

No Results Posted as of Mar 14, 2023