Bladder CancerNCT07545694
Study on the Effects of Drugs That Modulate the Endocannabinoid System on Spontaneous and Induced Contractility of the Human Detrusor Muscle
An observational study of Bladder Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 12 Nov 2025to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bladder cancer scheduled for elective resection surgery at the reference center, specifically the U.O.C. di Clinica Urologica at Fondazione Policlinico Universitario A. Gemelli in Rome, will be enrolled
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo A. Gemelli, 100168 - Roma
Rome
Maria Chiara Sighinolfi, Dr.
About this study
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.
Read the detailed description
This is a prospective, monocentric, observational in vitro study designed to investigate the role of the endocannabinoid system in the regulation of human detrusor contractility. The study evaluates the effects of pharmacological modulation of endocannabinoid receptors, enzymes involved in endocannabinoid synthesis and degradation, and endocannabinoid transport mechanisms on both spontaneous and neuronally induced contractile activity of human detrusor muscle.
The endocannabinoid system has been implicated in the regulation of lower urinary tract function, including sensory signaling and smooth muscle contractility. Experimental evidence suggests that cannabinoid receptor activation may modulate neurotransmitter release and detrusor muscle activity. However, most available data derive from animal models, and findings in human tissues remain limited and sometimes conflicting. A better characterization of the role of endocannabinoid signaling in human detrusor contractility may provide insight into potential therapeutic targets for disorders such as detrusor overactivity and overactive bladder syndrome.
Bladder tissue samples will be obtained from surgical specimens and processed for in vitro functional studies. Detrusor muscle strips will be prepared and mounted in organ baths to record contractile responses under controlled experimental conditions. Baseline motor activity and responses to neuronal stimulation will be assessed. Preparations will then be exposed to pharmacological agents acting on different components of the endocannabinoid system, including receptor agonists and antagonists, allosteric modulators, inhibitors of endocannabinoid biosynthesis and degradation, and inhibitors of endocannabinoid transport. Changes in contractile activity will be evaluated to characterize the functional contribution of these pathways.
The experimental procedures will be conducted in sequential phases to characterize baseline contractile responses, assess receptor-mediated effects, and evaluate the impact of modulation of endocannabinoid metabolism and transport. Clinical and demographic data will be recorded for descriptive purposes. The study is exploratory in nature and aims to generate mechanistic data on the role of the endocannabinoid system in human detrusor physiology.
- Conditions
- Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of CB receptor agonists, antagonists and allosteric modulators, endocannabinoid synthesis/catabolism enzyme inhibitors, and EMT transporter inhibitors on EFS-induced submaximal contractions of detrusor preparations
Evaluate the change in amplitude on submaximal contractions induced by electrical field stimulation (EFS) in human detrusor tissue strips mounted in organ baths following exposure to specified drugs
Measured: Time of in vitro organ bath pharmacological assessment (during the 30-month study period, post-tissue collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start12 Nov 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Chiara Sighinolfi, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545694
- Sponsor's protocol ID
- 8157
- Status last verified
- Nov 2025
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects of Drugs That Modulate the Endocannabinoid System on Spontaneous and Induced Contractility of the Human Detrusor Muscle
- ClinicalTrials.gov ID
- NCT07545694
- Acronym / sponsor ID
- 8157
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, monocentric, observational in vitro study designed to investigate the role of the endocannabinoid system in the regulation of human detrusor contractility. The study evaluates the effects of pharmacological modulation of endocannabinoid receptors, enzymes involved in endocannabinoid synthesis and degradation, and endocannabinoid transport mechanisms on both spontaneous and neuronally induced contractile activity of human detrusor muscle.
The endocannabinoid system has been implicated in the regulation of lower urinary tract function, including sensory signaling and smooth muscle contractility. Experimental evidence suggests that cannabinoid receptor activation may modulate neurotransmitter release and detrusor muscle activity. However, most available data derive from animal models, and findings in human tissues remain limited and sometimes conflicting. A better characterization of the role of endocannabinoid signaling in human detrusor contractility may provide insight into potential therapeutic targets for disorders such as detrusor overactivity and overactive bladder syndrome.
Bladder tissue samples will be obtained from surgical specimens and processed for in vitro functional studies. Detrusor muscle strips will be prepared and mounted in organ baths to record contractile responses under controlled experimental conditions. Baseline motor activity and responses to neuronal stimulation will be assessed. Preparations will then be exposed to pharmacological agents acting on different components of the endocannabinoid system, including receptor agonists and antagonists, allosteric modulators, inhibitors of endocannabinoid biosynthesis and degradation, and inhibitors of endocannabinoid transport. Changes in contractile activity will be evaluated to characterize the functional contribution of these pathways.
The experimental procedures will be conducted in sequential phases to characterize baseline contractile responses, assess receptor-mediated effects, and evaluate the impact of modulation of endocannabinoid metabolism and transport. Clinical and demographic data will be recorded for descriptive purposes. The study is exploratory in nature and aims to generate mechanistic data on the role of the endocannabinoid system in human detrusor physiology.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bladder cancer scheduled for elective resection surgery at the reference center, specifically the U.O.C. di Clinica Urologica at Fondazione Policlinico Universitario A. Gemelli in Rome, will be enrolled
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effects of CB receptor agonists, antagonists and allosteric modulators, endocannabinoid synthesis/catabolism enzyme inhibitors, and EMT transporter inhibitors on EFS-induced submaximal contractions of detrusor preparations
Time frame: Time of in vitro organ bath pharmacological assessment (during the 30-month study period, post-tissue collection)
Evaluate the change in amplitude on submaximal contractions induced by electrical field stimulation (EFS) in human detrusor tissue strips mounted in organ baths following exposure to specified drugs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Chiara Sighinolfi principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MARIA CHIARA SIGHINOLFI, DR (0039 3921329216, mariachiara.sighinolfi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of CB receptor agonists, antagonists and allosteric modulators, endocannabinoid synthesis/catabolism enzyme inhibitors, and EMT transporter inhibitors on EFS-induced submaximal contractions of detrusor preparations (time frame: Time of in vitro organ bath pharmacological assessment (during the 30-month study period, post-tissue collection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.