Ovary TorsionNCT05060120
Biomarker Panel in Ovarian Torsion
An observational study of Ovary Torsion and Adnexal Torsion, run by Assuta Ashdod Hospital at 2 sites in Israel.
Trial summary
The overall goal of the project is to find a panel of novel biomarkers for early detection of ovarian torsion. Read more about this study
- Who is it for?
- Ages 12 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovary Torsion, Adnexal Torsion
- What is being tested?
- biomakers for ovarian torsion and peritoneal fluid proteins analysis
- How many people
- 20 participants
- Where
- 2 sitesIsrael
- Study dates
- 12 Sep 2021to Aug 2024
- Phase
- Observational
- 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 12 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Female patients between 12 and 50 years, who were admitted to the gynecological emergency room at Assuta medical center with signs and symptoms suggestive of ovarian torsion.
Who may be able to join
- Female patients between 12 and 50 years who were admitted to the gynecological emergency room at Assuta medical center with signs and symptoms suggestive of ovarian torsion
- Patients that will undergo laparoscopy for the diagnosis of ovarian torsion
- Able to provide informed consent for themselves or have a legal guardian that can provide informed consent (in cases of patients under 18 years old)
Who cannot join
- Patients that are unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Assuta Ashdod University Hospital
Ashdod
Oshri Barel, MD, +972559382117, oshrib@assuta.co.il
Oshri Barel, MD
- Recruiting
Assuta Ashdod University Hospital
Ashdod
Oshri Barel, MD, +972559382117, oshrib@assuta.co.il
Oshri Barel, MD
About this study
Official title: Biomarker Panel for Early Diagnosis of Ovarian Torsion
The overall goal of the project is to find a panel of novel biomarkers for early detection of ovarian torsion.
Read the detailed description
The overall goal of the project is to find a panel of novel biomarkers for early detection of ovarian torsion.
The specifc aims of the current study are:
- Screen for changes in blood protein biomarkers concentrations specifc for patients with ovarian torsion. The biomarkers are: D-Dimer (21.7-5,280 ng/ml), FABP4/A-FABP (0.637-155 ng/ml), GM-CSF (0.012-2.98 ng/ml), ICAM-1/CD54 (6.9-1674 ng/ml), IFN-γ (0.058-14.2 ng/ml), IL-1α (0.005-1.27 ng/ml), IL-6 (0.005-1.2 ng/ml), IL-10 (0.005-1.2 ng/ml), IL-17/IL-17A (0.012-3.1 ng/ml), Park7/DJ-1 (0.26- 63.1 ng/ml), TNF-α (0.01-2.4 ng/ml), TSLP (0.003-0.7 ng/ml), VCAM-1/CD106 (7.8-1891 ng/ml) and VEGF (0.008-2.4 ng/ml).
- Compare the amount of oxidative stress defense proteins SOD1, Catalase, and Thioredoxin amount in the peritoneal fluid wash between patients with or without confirmed ovarian torsion. To our knowledge, this is the first study that specifically evaluates the expression of oxidation stress defense proteins in ovarian torsion. The results will enable us to decide whether to include oxidation stress biomarkers within the panel.
- Study population methodology and techniques
A prospective, 12-24 months study.
20 Patients with confirmed ovarian torsion will be enrolled.
The patients will complete a questionnaire prior to and following the procedure
3.5ml blood samples will be obtained immediately before laparoscopy, postoperative day, and four weeks after laparoscopy during the follow-up.
The peritoneal fluid wash will be collected during the laparoscopy from 14 patients (out of the 20 enrolled) that will provide additional written consent specific for the procedure.
20 Patients suspected of ovarian torsion with no ovarian torsion, as confirmed by laparoscopy, will be enrolled.
The patients will complete a questionnaire prior to and following the procedure
5ml blood samples will be obtained immediately before laparoscopy and four weeks after laparoscopy during the follow-up.
The peritoneal fluid wash will be collected during the laparoscopy from 14 patients (out of the 20 enrolled) that will provide additional written consent specific for the procedure.
20 Healthy controls will be enrolled and provide a 5ml blood sample.
- Conditions
- Ovary Torsion, Adnexal Torsion
- Being tested
- biomakers for ovarian torsion, peritoneal fluid proteins analysis
- Medical subject headings
- Ovarian Torsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomakers for ovarian torsionDiagnostic test
Blood biomarkers analysis using multiplex ELISA: The Luminex system is a magnetic bead-based multiplex ELISA that enable to measure simultaneously multiple proteins within the same sample. Human magnetic Luminex assay will be used for the following analytes: D-Dimer (21.7-5,280 ng/ml), FABP4/A-FABP (0.637-155 ng/ml), GM-CSF (0.012-2.98 ng/ml), ICAM-1/CD54 (6.9-1674 ng/ml), IFN-γ (0.058-14.2 ng/ml), IL-1α (0.005-1.27 ng/ml), IL-6 (0.005-1.2 ng/ml), IL-10 (0.005-1.2 ng/ml), IL-17/IL-17A (0.012-3.1 ng/ml), Park7/DJ-1 (0.26- 63.1 ng/ml), TNF-α (0.01-2.4 ng/ml), TSLP (0.003-0.7 ng/ml), VCAM-1/CD106 (7.8-1891 ng/ml) and VEGF (0.008-2.4 ng/ml). Plasma samples stored at -70°C will be sent to accredited lab at BioTest (Israel) for performing the multiplex ELISA readout assay test using MagPix system.
peritoneal fluid proteins analysisDiagnostic test
Western blot for peritoneal fluid proteins analysis
We will look for the relative abundance of proteins involved in the protection of cells against oxidative stress and the regulation of reactive oxygen species (ROS) using western blot. Superoxide dismutase 1 (SOD1, 16kDa) scavenges superoxides (O-2) within cells. Catalase (60kDa) is hydrogen peroxide (H2O2) scavenging enzyme regulate ROS concentrations within cells by reducing H202 into O2 and water. Thioredoxin (12kDa) facilitates the reduction of proteins via cysteine thiol-disulfide exchange. Alpha smooth muscle actin (42kDa) will be used as a loading control. These four proteins will be resolved by western blot given their different molecular weights using western blot cocktail antibodies (abcam # ab179843).
| Study group | Role | What they receive |
|---|---|---|
| confirmed ovarian torsion | immediately before laparoscopy and 1 day post- operation and four weeks after laparoscopy a panel of serum biomarkers will be tested Receives: Diagnostic Test: biomakers for ovarian torsion; Diagnostic Test: peritoneal fluid proteins analysis | |
| confirmed non ovarian torsion | immediately before laparoscopy Receives: Diagnostic Test: biomakers for ovarian torsion | |
| control group | match control Compare healthy controls with patients with or without ovarian torsion as confirmed by laparoscopy Receives: Diagnostic Test: biomakers for ovarian torsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative biochemical test -BIOMARKER PANEL FOR OVARIAN TORSION
Screen for elevation in blood protein biomarkers concentrations specifc for patients with ovarian torsion. The biomarkers are: D-Dimer (21.7-5,280 ng/ml), FABP4/A-FABP (0.637-155 ng/ml), GM-CSF (0.012-2.98 ng/ml), ICAM-1/CD54 (6.9-1674 ng/ml), IFN-γ (0.058-14.2 ng/ml), IL-1α (0.005-1.27 ng/ml), IL-6 (0.005-1.2 ng/ml), IL-10 (0.005-1.2 ng/ml), IL-17/IL-17A (0.012-3.1 ng/ml), Park7/DJ-1 (0.26- 63.1 ng/ml), TNF-α (0.01-2.4 ng/ml), TSLP (0.003-0.7 ng/ml), VCAM-1/CD106 (7.8-1891 ng/ml) and VEGF (0.008-2.4 ng/ml).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start12 Sep 2021
- Primary completionAug 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ovary TorsionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Ashdod Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oshri Barell, Assuta Ashdod Hospital
- Investigators
- Batel Hamou, MD, Principal investigator, Assuta Ashdod University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060120
- Sponsor's protocol ID
- AAA-21-0094
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Swenson DW, Lourenco AP, Beaudoin FL, Grand DJ, Killelea AG, McGregor AJ. Ovarian torsion: Case-control study comparing the sensitivity and specificity of ultrasonography and computed tomography for diagnosis in the emergency department. Eur J Radiol. 2014 Apr;83(4):733-8. doi: 10.1016/j.ejrad.2014.01.001. Epub 2014 Jan 8.
PubMed 24480106Cohen SB, Wattiez A, Stockheim D, Seidman DS, Lidor AL, Mashiach S, Goldenberg M. The accuracy of serum interleukin-6 and tumour necrosis factor as markers for ovarian torsion. Hum Reprod. 2001 Oct;16(10):2195-7. doi: 10.1093/humrep/16.10.2195.
PubMed 11574515Boaz M, Chernin G, Schwartz I, Katzir Z, Schwartz D, Agbaria A, Gal-Oz A, Weinstein T. C-reactive protein and carotid and femoral intima media thickness: predicting inflammation. Clin Nephrol. 2013 Dec;80(6):449-55. doi: 10.5414/CN108067.
PubMed 24131677Kart C, Aran T, Guven S, Karahan SC, Yulug E. Acute increase in plasma D-dimer level in ovarian torsion: an experimental study. Hum Reprod. 2011 Mar;26(3):564-8. doi: 10.1093/humrep/deq378. Epub 2011 Jan 17.
PubMed 21242148Guven S, Kart C, Guvendag Guven ES, Cetin EC, Mentese A. Is the measurement of serum ischemia-modified albumin the best test to diagnose ovarian torsion? Gynecol Obstet Invest. 2015;79(4):269-75. doi: 10.1159/000367787. Epub 2015 Jan 9.
PubMed 25591981Khreiss T, Jozsef L, Potempa LA, Filep JG. Conformational rearrangement in C-reactive protein is required for proinflammatory actions on human endothelial cells. Circulation. 2004 Apr 27;109(16):2016-22. doi: 10.1161/01.CIR.0000125527.41598.68. Epub 2004 Mar 29.
PubMed 15051635Uyanikoglu H, Hilali NG, Yardimciel M, Koyuncu I. A new biomarker for the early diagnosis of ovarian torsion: SCUBE-1. Clin Exp Reprod Med. 2018 Jun;45(2):94-99. doi: 10.5653/cerm.2018.45.2.94. Epub 2018 Jun 29.
PubMed 29984210Piper HG, Oltmann SC, Xu L, Adusumilli S, Fischer AC. Ovarian torsion: diagnosis of inclusion mandates earlier intervention. J Pediatr Surg. 2012 Nov;47(11):2071-6. doi: 10.1016/j.jpedsurg.2012.06.011.
PubMed 23164000
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Panel for Early Diagnosis of Ovarian Torsion
- ClinicalTrials.gov ID
- NCT05060120
- Acronym / sponsor ID
- AAA-21-0094
- Conditions
- Ovary Torsion, Adnexal Torsion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assuta Ashdod HospitalUniversity, hospital or other
- Study start
- 12 Sep 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 29 Sep 2021 (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 overall goal of the project is to find a panel of novel biomarkers for early detection of ovarian torsion.
Detailed description
The overall goal of the project is to find a panel of novel biomarkers for early detection of ovarian torsion.
The specifc aims of the current study are:
- Screen for changes in blood protein biomarkers concentrations specifc for patients with ovarian torsion. The biomarkers are: D-Dimer (21.7-5,280 ng/ml), FABP4/A-FABP (0.637-155 ng/ml), GM-CSF (0.012-2.98 ng/ml), ICAM-1/CD54 (6.9-1674 ng/ml), IFN-γ (0.058-14.2 ng/ml), IL-1α (0.005-1.27 ng/ml), IL-6 (0.005-1.2 ng/ml), IL-10 (0.005-1.2 ng/ml), IL-17/IL-17A (0.012-3.1 ng/ml), Park7/DJ-1 (0.26- 63.1 ng/ml), TNF-α (0.01-2.4 ng/ml), TSLP (0.003-0.7 ng/ml), VCAM-1/CD106 (7.8-1891 ng/ml) and VEGF (0.008-2.4 ng/ml).
- Compare the amount of oxidative stress defense proteins SOD1, Catalase, and Thioredoxin amount in the peritoneal fluid wash between patients with or without confirmed ovarian torsion. To our knowledge, this is the first study that specifically evaluates the expression of oxidation stress defense proteins in ovarian torsion. The results will enable us to decide whether to include oxidation stress biomarkers within the panel.
- Study population methodology and techniques
A prospective, 12-24 months study.
20 Patients with confirmed ovarian torsion will be enrolled.
The patients will complete a questionnaire prior to and following the procedure
3.5ml blood samples will be obtained immediately before laparoscopy, postoperative day, and four weeks after laparoscopy during the follow-up.
The peritoneal fluid wash will be collected during the laparoscopy from 14 patients (out of the 20 enrolled) that will provide additional written consent specific for the procedure.
20 Patients suspected of ovarian torsion with no ovarian torsion, as confirmed by laparoscopy, will be enrolled.
The patients will complete a questionnaire prior to and following the procedure
5ml blood samples will be obtained immediately before laparoscopy and four weeks after laparoscopy during the follow-up.
The peritoneal fluid wash will be collected during the laparoscopy from 14 patients (out of the 20 enrolled) that will provide additional written consent specific for the procedure.
20 Healthy controls will be enrolled and provide a 5ml blood sample.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| confirmed ovarian torsion | – | Diagnostic Test: biomakers for ovarian torsion, Diagnostic Test: peritoneal fluid proteins analysisimmediately before laparoscopy and 1 day post- operation and four weeks after laparoscopy a panel of serum biomarkers will be tested |
| confirmed non ovarian torsion | – | Diagnostic Test: biomakers for ovarian torsionimmediately before laparoscopy |
| control group | – | Diagnostic Test: biomakers for ovarian torsionmatch control Compare healthy controls with patients with or without ovarian torsion as confirmed by laparoscopy |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Female patients between 12 and 50 years, who were admitted to the gynecological emergency room at Assuta medical center with signs and symptoms suggestive of ovarian torsion.
Key inclusion criteria (3 listed)
- Female patients between 12 and 50 years who were admitted to the gynecological emergency room at Assuta medical center with signs and symptoms suggestive of ovarian torsion
- Patients that will undergo laparoscopy for the diagnosis of ovarian torsion
- Able to provide informed consent for themselves or have a legal guardian that can provide informed consent (in cases of patients under 18 years old)
Key exclusion criteria (1 listed)
- Patients that are unable to provide informed consent
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 |
|---|---|---|
| biomakers for ovarian torsionBlood biomarkers analysis using multiplex ELISA: The Luminex system is a magnetic bead-based multiplex ELISA that enable to measure simultaneously multiple proteins within the same sample. Human magnetic Luminex assay will be used for the following analytes: D-Dimer (21.7-5,280 ng/ml), FABP4/A-FABP (0.637-155 ng/ml), GM-CSF (0.012-2.98 ng/ml), ICAM-1/CD54 (6.9-1674 ng/ml), IFN-γ (0.058-14.2 ng/ml), IL-1α (0.005-1.27 ng/ml), IL-6 (0.005-1.2 ng/ml), IL-10 (0.005-1.2 ng/ml), IL-17/IL-17A (0.012-3.1 ng/ml), Park7/DJ-1 (0.26- 63.1 ng/ml), TNF-α (0.01-2.4 ng/ml), TSLP (0.003-0.7 ng/ml), VCAM-1/CD106 (7.8-1891 ng/ml) and VEGF (0.008-2.4 ng/ml). Plasma samples stored at -70°C will be sent to accredited lab at BioTest (Israel) for performing the multiplex ELISA readout assay test using MagPix system. | Diagnostic test | confirmed non ovarian torsion, confirmed ovarian torsion, control group |
| peritoneal fluid proteins analysisWestern blot for peritoneal fluid proteins analysis We will look for the relative abundance of proteins involved in the protection of cells against oxidative stress and the regulation of reactive oxygen species (ROS) using western blot. Superoxide dismutase 1 (SOD1, 16kDa) scavenges superoxides (O-2) within cells. Catalase (60kDa) is hydrogen peroxide (H2O2) scavenging enzyme regulate ROS concentrations within cells by reducing H202 into O2 and water. Thioredoxin (12kDa) facilitates the reduction of proteins via cysteine thiol-disulfide exchange. Alpha smooth muscle actin (42kDa) will be used as a loading control. These four proteins will be resolved by western blot given their different molecular weights using western blot cocktail antibodies (abcam # ab179843). | Diagnostic test | confirmed ovarian torsion |
Primary outcome
preoperative biochemical test -BIOMARKER PANEL FOR OVARIAN TORSION
Time frame: 2 years
Screen for elevation in blood protein biomarkers concentrations specifc for patients with ovarian torsion. The biomarkers are: D-Dimer (21.7-5,280 ng/ml), FABP4/A-FABP (0.637-155 ng/ml), GM-CSF (0.012-2.98 ng/ml), ICAM-1/CD54 (6.9-1674 ng/ml), IFN-γ (0.058-14.2 ng/ml), IL-1α (0.005-1.27 ng/ml), IL-6 (0.005-1.2 ng/ml), IL-10 (0.005-1.2 ng/ml), IL-17/IL-17A (0.012-3.1 ng/ml), Park7/DJ-1 (0.26- 63.1 ng/ml), TNF-α (0.01-2.4 ng/ml), TSLP (0.003-0.7 ng/ml), VCAM-1/CD106 (7.8-1891 ng/ml) and VEGF (0.008-2.4 ng/ml).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 24480106Swenson DW, Lourenco AP, Beaudoin FL, Grand DJ, Killelea AG, McGregor AJ. Ovarian torsion: Case-control study comparing the sensitivity and specificity of ultrasonography and computed tomography for diagnosis in the emergency department. Eur J Radiol. 2014 Apr;83(4):733-8. doi: 10.1016/j.ejrad.2014.01.001. Epub 2014 Jan 8.
- Background: PubMed 11574515Cohen SB, Wattiez A, Stockheim D, Seidman DS, Lidor AL, Mashiach S, Goldenberg M. The accuracy of serum interleukin-6 and tumour necrosis factor as markers for ovarian torsion. Hum Reprod. 2001 Oct;16(10):2195-7. doi: 10.1093/humrep/16.10.2195.
- Background: PubMed 24131677Boaz M, Chernin G, Schwartz I, Katzir Z, Schwartz D, Agbaria A, Gal-Oz A, Weinstein T. C-reactive protein and carotid and femoral intima media thickness: predicting inflammation. Clin Nephrol. 2013 Dec;80(6):449-55. doi: 10.5414/CN108067.
- Background: PubMed 21242148Kart C, Aran T, Guven S, Karahan SC, Yulug E. Acute increase in plasma D-dimer level in ovarian torsion: an experimental study. Hum Reprod. 2011 Mar;26(3):564-8. doi: 10.1093/humrep/deq378. Epub 2011 Jan 17.
- Background: PubMed 25591981Guven S, Kart C, Guvendag Guven ES, Cetin EC, Mentese A. Is the measurement of serum ischemia-modified albumin the best test to diagnose ovarian torsion? Gynecol Obstet Invest. 2015;79(4):269-75. doi: 10.1159/000367787. Epub 2015 Jan 9.
- Background: PubMed 15051635Khreiss T, Jozsef L, Potempa LA, Filep JG. Conformational rearrangement in C-reactive protein is required for proinflammatory actions on human endothelial cells. Circulation. 2004 Apr 27;109(16):2016-22. doi: 10.1161/01.CIR.0000125527.41598.68. Epub 2004 Mar 29.
- Background: PubMed 29984210Uyanikoglu H, Hilali NG, Yardimciel M, Koyuncu I. A new biomarker for the early diagnosis of ovarian torsion: SCUBE-1. Clin Exp Reprod Med. 2018 Jun;45(2):94-99. doi: 10.5653/cerm.2018.45.2.94. Epub 2018 Jun 29.
- Results publication: PubMed 23164000Piper HG, Oltmann SC, Xu L, Adusumilli S, Fischer AC. Ovarian torsion: diagnosis of inclusion mandates earlier intervention. J Pediatr Surg. 2012 Nov;47(11):2071-6. doi: 10.1016/j.jpedsurg.2012.06.011.
- Individual participant dataSharing planned: No
Related trials for Ovary Torsion
RecruitingPhase 3
Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion
Adnexal Torsion
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.
Batel Hamou, MD principal investigator
Assuta Ashdod University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovary Torsion and Adnexal Torsion, run by Assuta Ashdod Hospital at 2 sites in Israel.
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 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: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oshri Barel, md (972559382117, oshrib@assuta.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative biochemical test -BIOMARKER PANEL FOR OVARIAN TORSION (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05060120, which also lists 8 linked publications.
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 29 Sep 2021.