Trained immunity induced by BCG in urothelial carcinoma

Completed

Conditions: Non-muscle invasive bladder cancer
10038364
10004994

Registration Number: NL-OMON47732

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

1. Presence of high-grade Ta or T1 urothelial carcinoma of the bladder with or without carcinoma in situ; tumor can be primary or recurrent
2. Able to communicate in Dutch, and read and understand the patient information and informed consent form and fill out questionnaires
3. Signed and dated informed consent form
4. Complete resection of (visible) tumor at start of BCG therapy as determined via re-TURT or negative cystoscopy/cytology (at most 6 weeks prior to BCG therapy initiation)

Exclusion Criteria

1. Any previous intravesical BCG therapy
2. Presence of primary CIS only
3. Presence of histopathologically proven muscle-invasive urothelial carcinoma of the bladder at first or re-TUR surgical specimens
4. Presence of tumor stage cN1 of cM1 as assessed by CT-thorax/abdomen
5. Presence of any upper urinary tract tumors
6. Histology subtype of resected tumor is not predominant urothelial carcinoma
7. Presence of another malignancy other than basal cell carcinoma of the skin or prostate cancer under active surveillance
8. Presence of pregnancy or lactation
9. Presence of active tuberculosis, any form of immunodeficiency (e.g. HIV + serology, transplant recipients) and/or any other contraindication of BCG therapy
10. Patients who have received any systemic cytostatic agents within the last 3 months
11. Patients younger than 18 and older than 85 years of age
12. Patients with uncontrollable urinary tract infection

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Study parameters include (i) histone 3 lysine 4 (H3K4) trimethylation (me3),<br /><br>H3K9me3, and H3K27 acetylation levels at the TNF-, IL-6 and IL1-b promoters in<br /><br>circulating monocytes during BCG treatment; (ii) TNF-, IL-6 and IL-1b levels<br /><br>produced by ex vivo stimulated monocytes during treatment, (iii) DNA variant<br /><br>genotypes and molecular bladder tumor subtypes, (iv) CyPRIT score, (v) (time<br /><br>to) tumor recurrence. </p><br>

Secondary Outcome Measures