Can We Predict of the Response of High Risk Non Muscle Invasive Bladder Cancer Patients to Intravesical Bacillus Calmette-Guerin? The Role of Immunological Markers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04723121

Enrollment

204

Registered

2021-01-25

Start date

2013-03-01

Completion date

2020-12-01

Last updated

2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Bladder cancer, Bacillus Calmette-Guérin response, Prediction, Urinary cytokines, T cells, Recurrence, Progression

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.

Detailed description

Background: 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.

Interventions

DIAGNOSTIC_TESTUrine ELISA for immunological markers (IL-2 and IL-10)

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

DIAGNOSTIC_TESTReverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

1. Patients with previous BCG instillation, 2. benign pathology 3. Variant histology 4. Non urothelial carcinoma, 5. concommitent upper tract urothelial tumors, detrusor muscle invasion 6. low or intermediate risk NMIBC

Design outcomes

Primary

Measure	Time frame	Description
Initial BCG complete response	3 months	free cystoscopy/negative cytology at 3 months.
Recurrence	1 year	Recurrence is defined as development of new tumor/positive cytology in patients with ICR
Progression	1 year	persistent/recurrent tumor during or after treatment with increasing tumor grade or upstaging to muscle invasion after initial complete response

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026