NCT04723121

Brief Summary

Intravesical BCG is the mainstay adjuvant management of high risk NMIBC. Adequacy of immune system stimulation is the determinant factor for patient response to BCG. Immunological markers for BCG-response could be helpful for urologists especially in the era of BCG shortage. Objectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2013

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

6.2 years

First QC Date

January 20, 2021

Last Update Submit

January 22, 2021

Conditions

Bladder Cancer

Keywords

Bladder cancerBacillus Calmette-Guérin responsePredictionUrinary cytokinesT cellsRecurrenceProgression

Outcome Measures

Primary Outcomes (3)

  • Initial BCG complete response

    free cystoscopy/negative cytology at 3 months.

    3 months

  • Recurrence

    Recurrence is defined as development of new tumor/positive cytology in patients with ICR

    1 year

  • Progression

    persistent/recurrent tumor during or after treatment with increasing tumor grade or upstaging to muscle invasion after initial complete response

    1 year

Study Arms (1)

High risk NMIBC

OTHER

Patients with primary or recurrent NMIBC for whom primary TURBT was done and intravesical BCG was administered

Diagnostic Test: Urine ELISA for immunological markers (IL-2 and IL-10)Diagnostic Test: Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis

Interventions

Urine ELISA for immunological markers (IL-2 and IL-10)DIAGNOSTIC_TEST

IL-2 and IL-10 levels were measured in the supernatants. Natural human-produced IL-2 and IL-10 concen¬trations were determined in the urine of all patients and controls by solid phase ELISA Quantikine IL-2 Immunoassay and IL-10 Immunoassay, respectively

High risk NMIBC
Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysisDIAGNOSTIC_TEST

blood samples using QIAamp® RNA Blood Mini kit (QIAGEN, USA). 1 μg of total RNA was reverse transcribed with random primers, using High Capacity cDNA Archive Kit (Applied Biosystems, Foster City, CA, USA). RT-qPCR analysis was carried out with SYBER Green PCR Master Mix (Applied Biosystems, Foster City, CA, USA). Primers for TNF-α, CTLA4, T-bet+, GATA3+, FoxP3+ and GABDH as PCR control

High risk NMIBC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with primary or recurrent NMIBC for whom primary TURBT was done.

You may not qualify if:

  • Patients with previous BCG instillation,
  • benign pathology
  • Variant histology
  • Non urothelial carcinoma,
  • concommitent upper tract urothelial tumors, detrusor muscle invasion
  • low or intermediate risk NMIBC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsRecurrenceDisease Progression

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amr A Elsawy

    Urology and Nephrology Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 25, 2021

Study Start

March 1, 2013

Primary Completion

May 1, 2019

Study Completion

December 1, 2020

Last Updated

January 25, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)