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OpenTrials
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NCT Number: NCT04723121

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

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.

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Key information

Conditions

Bladder Cancer Disease Attributes Disease Progression Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology and Nephrology Center

Al Mansurah, DK, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

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

Diagnostic 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

Primary outcomes

  1. Initial BCG complete response

    Time frame: 3 months

    free cystoscopy/negative cytology at 3 months.

  2. Recurrence

    Time frame: 1 year

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

  3. Progression

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2020
First posted
Jan 25, 2021
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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