Testicular Torsion and TLR 4 Was InvestigatedNCT05558072
Testicular Torsion
A study testing Toll-like receptor 4 in people with Testicular Torsion and TLR 4 Was Investigated, run by Hisar Intercontinental Hospital.
Trial summary
Background: Testicular torsion is a scrotal emergency that results in impaired blood supply to the testis and ischemia of the testis as a result of the rotation of the spermatic cord around itself. Read more about this study
- Who is it for?
- Ages 0 days to 16 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Testicular Torsion and TLR 4 Was Investigated
- What is being tested?
- Toll-like receptor 4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 0 days to 16 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- testicular torsion
- newborn, adolescent,
Who cannot join
- orchitis, urinary infection, trauma,
About this study
Official title: Is There a Toll-like 4 Receptor Relationship in Patients With Testicular Torsion?
Background:
Testicular torsion is a scrotal emergency that results in impaired blood supply to the testis and ischemia of the testis as a result of the rotation of the spermatic cord around itself. The etiology of testicular torsion is not clear, but various predisposing factors are responsible for the occurrence of testicular torsion.
Read more
Recently, with the discovery of "Toll-Like Receptors" (TLRs), new horizons have been opened in the field of innate immune system-related diseases.
Objective: To mediate the relationship between testicular torsion and TLR4 receptors.
Material-Method: Testicular specimens of patients who developed testicular ischemia after testicular torsion and underwent orchiectomy between 2012-2022 were reached. A study of TLR 4 receptors was performed in these testicular specimens. The patients were divided into two groups according to their ages newborns and adolescents.
Read the detailed description
Analysis of 32 newborns and 32 adolescents between the ages of 14 and 16 (mean age was 15.17 ± 0.98) testicular tissue lysate using Toll-Like Receptor antibody 4 (TLR4) ELISA (Enzyme-Linked ImmunoSorbent Assay).
Toll-like receptor 4 is a transmembrane protein that in humans is encoded by the TLR4 gene. Its activation leads to the production of inflammatory cytokines.
- Being tested
- Toll-like receptor 4
- Keywords
- testicular torsion,, Toll-like receptors (TLR),, child, newborn, adolescent
- Medical subject headings
- Spermatic Cord Torsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toll-like receptor 4Genetic
Toll-like receptor 4
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Newborn Receives: Genetic: Toll-like receptor 4 |
| Group 2 | Experimental | adolescent Receives: Genetic: Toll-like receptor 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toll-like receptor 4 positives or negative
testicular torsion
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Jan 2012
- Primary completion30 Dec 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular Torsion and TLR 4 Was InvestigatedStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisar Intercontinental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basri Cakiroglu, Hisar Intercontinental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558072
- Sponsor's protocol ID
- 2022/18
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Toll-like 4 Receptor Relationship in Patients With Testicular Torsion?
- ClinicalTrials.gov ID
- NCT05558072
- Acronym / sponsor ID
- 2022/18
- Keywords
- testicular torsion,, Toll-like receptors (TLR),, child, newborn, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hisar Intercontinental HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 28 Sep 2022 (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.
Background:
Testicular torsion is a scrotal emergency that results in impaired blood supply to the testis and ischemia of the testis as a result of the rotation of the spermatic cord around itself. The etiology of testicular torsion is not clear, but various predisposing factors are responsible for the occurrence of testicular torsion.
Recently, with the discovery of "Toll-Like Receptors" (TLRs), new horizons have been opened in the field of innate immune system-related diseases.
Objective: To mediate the relationship between testicular torsion and TLR4 receptors.
Material-Method: Testicular specimens of patients who developed testicular ischemia after testicular torsion and underwent orchiectomy between 2012-2022 were reached. A study of TLR 4 receptors was performed in these testicular specimens. The patients were divided into two groups according to their ages newborns and adolescents.
Detailed description
Analysis of 32 newborns and 32 adolescents between the ages of 14 and 16 (mean age was 15.17 ± 0.98) testicular tissue lysate using Toll-Like Receptor antibody 4 (TLR4) ELISA (Enzyme-Linked ImmunoSorbent Assay).
Toll-like receptor 4 is a transmembrane protein that in humans is encoded by the TLR4 gene. Its activation leads to the production of inflammatory cytokines.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Genetic: Toll-like receptor 4Newborn |
| Group 2 | Experimental | Genetic: Toll-like receptor 4adolescent |
Who may qualify
- Ages
- 0 days to 16 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- testicular torsion
- newborn, adolescent,
Key exclusion criteria (1 listed)
- orchitis, urinary infection, trauma,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toll-like receptor 4Toll-like receptor 4 | Genetic | Group 1, Group 2 |
Primary outcome
Toll-like receptor 4 positives or negative
Time frame: 10 years
testicular torsion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Toll-like receptor 4 in people with Testicular Torsion and TLR 4 Was Investigated, run by Hisar Intercontinental Hospital.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toll-like receptor 4 positives or negative (time frame: 10 years). 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 28 Sep 2022.