Machine Learning-Based Prediction of BCG Response in High-Risk Non-Muscle Invasive Bladder Cancer Patients

NCT05332353 | Unknown DMC FDA Drug

• 1 other identifier: MD.22.03.622
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study aims at using Artificial intelligence to create a helpful unbiased machine learning-based model that predicts BCG unresponsiveness in high risk BCG-naïve NMIBC patients incorporating all potential clinico-pathological, radiological and/or molecular prognostic factors.

Conditions

Non-Muscle Invasive Bladder Cancer

Keywords

Machine Learning; BCG Response; Prediction; Non-Muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• BCG unresponsiveness

  T1/Ta HG recurrence within 6 months of adequate BCG therapy

  6 months

Study Arms (2)

BCG responders

Non-muscle invasive bladder cancer patients who do not have T1/Ta HG recurrence within 6 months of adequate BCG therapy.

Drug: Bacillus Calmette-Guerin

BCG non-responders

Non-muscle invasive bladder cancer patients who have T1/Ta HG recurrence within 6 months of adequate BCG therapy or CIS within 12 months of BCG therapy

Drug: Bacillus Calmette-Guerin

Interventions

Bacillus Calmette-Guerin DRUG

Bacillus Calmette-Guerin (BCG) is immunotherapy to prevent recurrence and progression of non muscle invasive bladder cancer.

Also known as: BCG

BCG non-responders; BCG responders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with diagnosed bladder tumors seen through the outpatient clinic in the urology department, Urology and Nephrology Center (Mansoura University, Egypt) will be assessed for eligibility. Patients who are meeting these criteria will be asked to participate in this prospective study and will be provided with an informed consent form. all patients will be thoroughly evaluated by medical history and physical examination, routine laboratory investigations, mpMRI lower abdomen and pelvis. Then, all patients will be managed by complete TURBT followed by re-staging TUR biopsy after 2-6 weeks. All included patients will be discharged to receive adjuvant intravesical BCG therapy and to be followed-up according to the predetermined protocol.

You may qualify if:

• Ability to give informed consent.
• High-risk NMIBC (any patient with high grade Ta or high grade T1 or CIS or recurrent multiple large tumors with low grade Ta/T1)
• Good performance status (Defined as: performance status 0 or 1 at the time of TURBT according to Eastern Cooperative Oncology Group-ECOG-).
• No prior history of BCG intravesical therapy.

You may not qualify if:

• History of previous radiotherapy or systemic chemotherapy.
• Post TURBT histopathology report showing any of the following;
• Benign histopathology.
• Muscle invasive urothelial carcinoma.
• Non urothelial carcinoma of the bladder.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Outside U.S./Canada, 35511, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

specimens of non muscle invasive bladder tumor

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Osama Ezzat, Ass. lect.

  Urology and Nephrology Center , Mansoura university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osama Ezzat, Ass. lect.

CONTACT

01023990432; osamaezzat1990@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 18, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

EG (1)