NCT07545694 Study on the Effects of Drugs That Modulate the Endocannabinoid System on Spontaneous and Induced Contractility of the Human Detrusor Muscle
| NCT ID | NCT07545694 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Bladder Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 65 participants |
| Start Date | 2025-11-12 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 65 participants in total. It began in 2025-11-12 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational, in vitro study is to evaluate the effects of drugs that modulate the endocannabinoid system on spontaneous and neuronally induced contractility of the human detrusor. The study will include adult patients undergoing elective radical cystectomy for bladder cancer. The main questions it aims to answer are whether modulation of endocannabinoid receptors, enzymes involved in endocannabinoid synthesis and degradation, and endocannabinoid transport mechanisms alters basal detrusor contractility and modifies excitatory motor responses induced by neuronal activation. Participants undergoing radical cystectomy will provide written informed consent for the collection of a small sample of macroscopically healthy bladder tissue from the surgical specimen. Detrusor muscle strips will be prepared and studied in vitro using organ bath techniques. Contractile activity will be recorded under baseline conditions and after electrical field stimulation, as well as following exposure to pharmacological modulators of the endocannabinoid system. Demographic, clinical, and pathological data will also be collected for descriptive analysis.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years. * Patients with bladder carcinoma at any stage of disease, undergoing upfront surgery or neoadjuvant therapy for more than 6 weeks, scheduled for surgery with curative/demolitive intent. * Signed written informed consent to participate in the study. Exclusion Criteria: * Age \< 18 years. * Procedures performed on an urgent/emergency basis. * Patients treated with corticosteroid therapy for immunorheumatic diseases. * Patients treated with radio-chemotherapy and undergoing surgery less than 6 weeks prior. * Refusal to sign written informed consent to participate in the study.
Contact & Investigator
Maria Chiara Sighinolfi
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT07545694 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07545694 currently recruiting?
Yes, NCT07545694 is actively recruiting participants. Contact the research team at mariachiara.sighinolfi@policlinicogemelli.it for enrollment information.
Where is the NCT07545694 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT07545694 clinical trial?
NCT07545694 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Maria Chiara Sighinolfi at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 65 participants.
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