NCT06662071

Brief Summary

The investigators are here to invite participants to participate in a medical research project, and this informed consent form provides participants with information to decide whether or not to participate in this study. Please read the following carefully and discuss any questions and terms that are not clear with the study doctor. The participants' participation in this study is completely voluntary and the project has been reviewed by the Research Ethics Committee of Qilu Hospital, Shandong University.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
293

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Oct 2024

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Oct 2024Sep 2028

Study Start

First participant enrolled

October 1, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

4 years

First QC Date

October 21, 2024

Last Update Submit

October 25, 2024

Conditions

Bladder Cancer

Keywords

OrganoidBladder Cancer

Outcome Measures

Primary Outcomes (1)

  • One-year RFS and Three-year RFS

    One-year tumour recurrence-free survival rate and Three-year tumour recurrence-free survival rate

    2024.10.01-2028.09.30

Secondary Outcomes (1)

  • One-year PFS and Three-year PFS

    2024.10.01-2028.09.30

Study Arms (3)

positive control group

BCG vaccine for bladder instillation

test group

Organoid-sensitive drug infusion

Other: Organoid culture

control group

Organoid non-sensitive drug infusion group

Other: Organoid culture

Interventions

Organoid cultureOTHER

Organoid culture of tumor tissue obtained during patient surgery

control grouptest group

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who need to come to the research center for treatment of bladder cancer

You may qualify if:

  • Age 18-80 years old, gender is not limited;
  • Patients with intermediate-risk and high-risk non-muscle invasive bladder cancer (NMIBC) requiring bladder perfusion therapy;
  • No prior bladder perfusion therapy (except immediate postoperative perfusion);
  • ECOG status score of 0-2;
  • Be able to comply with the trial protocol, have good compliance, cooperate in observing adverse events and efficacy and cooperate in follow-up, as judged by the investigator;
  • Voluntarily participate in this clinical trial, understand the study procedures and have signed the informed consent to participate in this study;

You may not qualify if:

  • bladder perforation during TURBT, postoperative gross haematuria, symptomatic severe chemical cystitis, and urinary tract infection;
  • Immunodeficient or damaged individuals (e.g., AIDS patients, patients on immunosuppressive drugs or radiotherapy);
  • Subjects with known allergies or sensitivities to the study drug, analogues, excipients, etc.
  • Subjects who have been taking hormonal drugs for a long period of time or have a history of drug abuse and dependence
  • Those who have recent pregnancy plans or are already pregnant or breastfeeding;
  • Those with abnormal blood counts, liver and kidney functions and coagulation indexes: (fulfilling 1 or more can be considered abnormal)
  • ① Neutrophil count (ANC) ≤1.5×10\*9/L;
  • white blood cell count (WBC) ≤ 3.0 × 10\*9 / L.
  • Platelet count (PLT) ≤90×10\*9/L;
  • Haemoglobin (HB) ≤90g/L; ⑤ Total bilirubin (TBIL) ≥1.5 × institutional upper limit of normal (ULN);
  • Estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73m²;
  • International Normalised Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≥ ULN (except for patients receiving anticoagulation therapy, subject to the investigator's opinion that this is a clinically acceptable outcome)
  • The subject has other factors that may force the study to be terminated mid-stream, such as:
  • The patient has a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML);
  • A previous history of a definite neurological or psychiatric disorder, including epilepsy or dementia;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Binzhou Medical University Hospital

Binzhou, Shandong, China

RECRUITING

Qilu Hospital of Shandong University Dezhou Hospital

Dezhou, Shandong, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Shandong Provincial Hospital Affiliated to Shandong First Medical University (Shandong Provincial Hospital)

Jinan, Shandong, China

RECRUITING

Shandong Third Hospital

Jinan, Shandong, China

RECRUITING

The First Affiliated Hospital Of Shandong First Medcial Unversity

Jinan, Shandong, China

RECRUITING

The second hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Jining No.1 People's Hospital

Jining, Shandong, China

RECRUITING

Liaocheng People's Hospital

Liaocheng, Shandong, China

RECRUITING

Linyi People's Hospital

Linyi, Shandong, China

RECRUITING

Qilu Hospital of Shandong University(Qing Dao)

Qingdao, Shandong, China

RECRUITING

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

Taian City Central Hospital

Taian, Shandong, China

RECRUITING

Weifang People's Hospital

Weifang, Shandong, China

RECRUITING

Yantai Yuhuanding Hospital

Yantai, Shandong, China

RECRUITING

Zaozhuang Municipal Hospital

Zaozhuang, Shandong, China

RECRUITING

Zibo Central Hospital

Zibo, Shandong, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

Jun Chen

CONTACT

+86 18560084873chenjunxinxiang@163.com

Lei Liu

CONTACT

+86 18560084337Linbaliulei@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 21, 2024

First Posted

October 28, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

October 28, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Locations

CN(17)