Oral LeukoplakiaNCT06469892

Saliva and Plasma Exosomes for Oral Leukoplakia Malignant Transformation Diagnosis and Oral Cancer Prognosis Monitoring

An observational study of Oral Leukoplakia and Oral Cancer, run by Beijing Stomatological Hospital, Capital Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The goal of this observational study is to test the expression levels of salivary and plasma exosomal miR-185 in patients with oral leukoplakia and oral squamous cell carcinoma. The main questions it aims to answer are: Is it possible to identify the cancer risk of oral leukoplakia in its early stages by detecting… Read more about this study

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Oral Leukoplakia, Oral Cancer
What is being tested?: Detect the expression level of miR-185 in salivary and plasma exosomes.
How many people: 225 participants
Where: 1 siteChina
Study dates: 13 Jun 2020to 30 Jul 2023
How long will I take part?: 1 Year
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 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants were from the Department of Stomatology, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.

Who may be able to join

Males or females aged 30~80 years.
Clinical diagnosis consistent with oral leukoplakia and oral cancer.
Individuals with local stimulating factors correlated with oral lesions (including residual roots, residual crowns, poor oral restorations, cheek biting, and tongue biting habits).
Oral lesions not subjected to any treatment, including laser, photodynamic therapy, radiotherapy, and chemotherapy.

Who cannot join

Pathological diagnosis of another disease rather than oral leukoplakia or squamous cell carcinoma.
Females who were pregnant or breastfeeding.
Individuals who had malignancy, severe and precariously controlled diabetes mellitus, episodes of cardiovascular disease, hepatic or renal dysfunction, respiratory disease, hematologic disease, or immune abnormalities in the past year.
Individuals with a psychiatric disorder.
Other conditions deemed inappropriate for study participation by the researchers.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Stomatological Hospital, Capital Medical University
Beijing, Beijing Municipality, 100010

Other trials in China

About this study

Official title: Application of Salivary and Plasma Exosomes in the Diagnosis of Oral Leukoplakia Malignant Transformation and Prognosis Monitoring of Oral Cancer

Is it possible to identify the cancer risk of oral leukoplakia in its early stages by detecting salivary and plasma exosomal miR-185?
Is it possible to monitor the cancer risk of oral leukoplakia and the prognosis of oral cancer using salivary exosomal miR-185?

Participants will be asked to:

Cooperate with the investigators in completing the oral examination.
Take saliva and plasma before the biopsy surgery.
Perform the biopsy surgery following the usual diagnostic procedures.
Attend regular follow-up appointments (every 3 months) for the duration of the study.

Read the detailed description

The first part of the study is a cross-sectional study in which the investigators will detect the expression level of salivary exosomal miR-185 in the participants at a single time point. The second part of the study is a prospective cohort study, in which the investigators will conduct regular follow-ups on the participants enrolled in the first part.

Conditions: Oral Leukoplakia, Oral Cancer
Being tested: Detect the expression level of miR-185 in salivary and plasma exosomes.
Keywords: Oral cancer, Oral leukoplakia, Exosome, miR-185, Diagnosis, Prognosis
Medical subject headings: Leukoplakia, Oral, Mouth Neoplasms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Detect the expression level of miR-185 in salivary and plasma exosomes.Other
Participants were instructed to refrain from eating, drinking, brushing their teeth, rinsing their mouth, or taking medications for one hour before saliva collection. They were then asked to bend over, lower their head, open their mouth, and allow saliva to flow naturally without chewing or spitting. Using a specialized container, 2 mL of unstimulated saliva was collected.
Participants fasted overnight before blood collection. Researchers used plasma tubes containing anticoagulant (EDTA) to obtain venous blood (4-5 mL) from the participants\' upper arm. Subsequently, the blood was gently inverted to ensure optimal contact with the anticoagulant before centrifugation at 2000 rpm and 4°C for 10 minutes. Following centrifugation, the supernatant was extracted.

What is being measured

The primary outcome is the main question the study is designed to answer.

The expression level of miR-185 in salivary exosomes
Exosomes were isolated from saliva using ultracentrifugation, and total RNA from the exosomes was extracted using TRIzol reagent. Subsequently, the expression level of miR-185 was detected by RT-qPCR.
Measured: Baseline, pre-biopsy surgery.
The expression level of miR-185 in plasma exosomes
Exosomes were isolated from plasma using ultracentrifugation, and total RNA from the exosomes was extracted using TRIzol reagent. Subsequently, the expression level of miR-185 was detected by RT-qPCR.
Measured: Baseline, pre-biopsy surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 202030 Jul 2023

First posted24 Jun 2024
Study start13 Jun 2020
Primary completion30 Jun 2023
Study completion30 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Oral LeukoplakiaStudies 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: Other
Time perspective: Other
Enrolment: 225 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT06469892
Sponsor's protocol ID: CMUSH-IRB-KJ-PJ-2020-10
Other IDs: Z191100006619042
Status last verified: Jun 2024
First submitted: 14 Jun 2024
Last updated: 24 Jun 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data on participants' gender, age, disease duration, lesion characteristics (location and size), tobacco, alcohol and betel nut consumption habits, histopathologic diagnosis, and miR-185 levels in saliva and plasma exosomes will be shared.

Publications

Jing R, Chen W, Wang H, Ju S, Cong H, Sun B, Jin Q, Chu S, Xu L, Cui M. Plasma miR-185 is decreased in patients with esophageal squamous cell carcinoma and might suppress tumor migration and invasion by targeting RAGE. Am J Physiol Gastrointest Liver Physiol. 2015 Nov 1;309(9):G719-29. doi: 10.1152/ajpgi.00078.2015. Epub 2015 Aug 27.
PubMed 26316588
Liu J, Han Y, Liu X, Wei S. Serum miR-185 Is a Diagnostic and Prognostic Biomarker for Non-Small Cell Lung Cancer. Technol Cancer Res Treat. 2020 Jan-Dec;19:1533033820973276. doi: 10.1177/1533033820973276.
PubMed 33251978
Zhang W, Sun Z, Su L, Wang F, Jiang Y, Yu D, Zhang F, Sun Z, Liang W. miRNA-185 serves as a prognostic factor and suppresses migration and invasion through Wnt1 in colon cancer. Eur J Pharmacol. 2018 Apr 15;825:75-84. doi: 10.1016/j.ejphar.2018.02.019. Epub 2018 Feb 15.
PubMed 29454608
Zhong WQ, Ren JG, Xiong XP, Man QW, Zhang W, Gao L, Li C, Liu B, Sun ZJ, Jia J, Zhang WF, Zhao YF, Chen G. Increased salivary microvesicles are associated with the prognosis of patients with oral squamous cell carcinoma. J Cell Mol Med. 2019 Jun;23(6):4054-4062. doi: 10.1111/jcmm.14291. Epub 2019 Mar 25.
PubMed 30907490
Nieuwland R, Siljander PR. A beginner's guide to study extracellular vesicles in human blood plasma and serum. J Extracell Vesicles. 2024 Jan;13(1):e12400. doi: 10.1002/jev2.12400.
PubMed 38193375
Witwer KW, Buzas EI, Bemis LT, Bora A, Lasser C, Lotvall J, Nolte-'t Hoen EN, Piper MG, Sivaraman S, Skog J, Thery C, Wauben MH, Hochberg F. Standardization of sample collection, isolation and analysis methods in extracellular vesicle research. J Extracell Vesicles. 2013 May 27;2. doi: 10.3402/jev.v2i0.20360. eCollection 2013.
PubMed 24009894
Coumans FAW, Brisson AR, Buzas EI, Dignat-George F, Drees EEE, El-Andaloussi S, Emanueli C, Gasecka A, Hendrix A, Hill AF, Lacroix R, Lee Y, van Leeuwen TG, Mackman N, Mager I, Nolan JP, van der Pol E, Pegtel DM, Sahoo S, Siljander PRM, Sturk G, de Wever O, Nieuwland R. Methodological Guidelines to Study Extracellular Vesicles. Circ Res. 2017 May 12;120(10):1632-1648. doi: 10.1161/CIRCRESAHA.117.309417.
PubMed 28495994
Vasconcelos MH, Caires HR, Abols A, Xavier CPR, Line A. Extracellular vesicles as a novel source of biomarkers in liquid biopsies for monitoring cancer progression and drug resistance. Drug Resist Updat. 2019 Dec;47:100647. doi: 10.1016/j.drup.2019.100647. Epub 2019 Oct 15.
PubMed 31704541
Jeppesen DK, Fenix AM, Franklin JL, Higginbotham JN, Zhang Q, Zimmerman LJ, Liebler DC, Ping J, Liu Q, Evans R, Fissell WH, Patton JG, Rome LH, Burnette DT, Coffey RJ. Reassessment of Exosome Composition. Cell. 2019 Apr 4;177(2):428-445.e18. doi: 10.1016/j.cell.2019.02.029.
PubMed 30951670
Vu LT, Gong J, Pham TT, Kim Y, Le MTN. microRNA exchange via extracellular vesicles in cancer. Cell Prolif. 2020 Nov;53(11):e12877. doi: 10.1111/cpr.12877. Epub 2020 Oct 6.
PubMed 33169503
Li B, Cao Y, Sun M, Feng H. Expression, regulation, and function of exosome-derived miRNAs in cancer progression and therapy. FASEB J. 2021 Oct;35(10):e21916. doi: 10.1096/fj.202100294RR.
PubMed 34510546
Lu TX, Rothenberg ME. MicroRNA. J Allergy Clin Immunol. 2018 Apr;141(4):1202-1207. doi: 10.1016/j.jaci.2017.08.034. Epub 2017 Oct 23.
PubMed 29074454
Mathieu M, Martin-Jaular L, Lavieu G, Thery C. Specificities of secretion and uptake of exosomes and other extracellular vesicles for cell-to-cell communication. Nat Cell Biol. 2019 Jan;21(1):9-17. doi: 10.1038/s41556-018-0250-9. Epub 2019 Jan 2.
PubMed 30602770
Wang L, Yin P, Wang J, Wang Y, Sun Z, Zhou Y, Guan X. Delivery of mesenchymal stem cells-derived extracellular vesicles with enriched miR-185 inhibits progression of OPMD. Artif Cells Nanomed Biotechnol. 2019 Dec;47(1):2481-2491. doi: 10.1080/21691401.2019.1623232.
PubMed 31219352

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Active, not recruitingPhase 2
Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
Erythroplakia, Oral Leukoplakia
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
RecruitingPhase 2
Pembrolizumab in Treating Participants With Leukoplakia
Erythroleukoplakia, Leukoplakia
RecruitingPhase 2
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Oral Leukoplakia

All Oral Leukoplakia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of Salivary and Plasma Exosomes in the Diagnosis of Oral Leukoplakia Malignant Transformation and Prognosis Monitoring of Oral Cancer
ClinicalTrials.gov ID: NCT06469892
Acronym / sponsor ID: CMUSH-IRB-KJ-PJ-2020-10
Conditions: Oral Leukoplakia, Oral Cancer
Keywords: Oral cancer, Oral leukoplakia, Exosome, miR-185, Diagnosis, Prognosis
Study type: Observational
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: Beijing Stomatological Hospital, Capital Medical UniversityUniversity, hospital or other
Study start: 13 Jun 2020 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 30 Jul 2023 (actual)
First posted: 24 Jun 2024 (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.

Is it possible to identify the cancer risk of oral leukoplakia in its early stages by detecting salivary and plasma exosomal miR-185?
Is it possible to monitor the cancer risk of oral leukoplakia and the prognosis of oral cancer using salivary exosomal miR-185?

Participants will be asked to:

Cooperate with the investigators in completing the oral examination.
Take saliva and plasma before the biopsy surgery.
Perform the biopsy surgery following the usual diagnostic procedures.
Attend regular follow-up appointments (every 3 months) for the duration of the study.

Detailed description

Study design

Observational model: Other
Time perspective: Other
Target follow-up: 1 Year

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants were from the Department of Stomatology, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.

Key inclusion criteria (4 listed)

Males or females aged 30~80 years.
Clinical diagnosis consistent with oral leukoplakia and oral cancer.
Individuals with local stimulating factors correlated with oral lesions (including residual roots, residual crowns, poor oral restorations, cheek biting, and tongue biting habits).
Oral lesions not subjected to any treatment, including laser, photodynamic therapy, radiotherapy, and chemotherapy.

Key exclusion criteria (5 listed)

Pathological diagnosis of another disease rather than oral leukoplakia or squamous cell carcinoma.
Females who were pregnant or breastfeeding.
Individuals who had malignancy, severe and precariously controlled diabetes mellitus, episodes of cardiovascular disease, hepatic or renal dysfunction, respiratory disease, hematologic disease, or immune abnormalities in the past year.
Individuals with a psychiatric disorder.
Other conditions deemed inappropriate for study participation by the researchers.

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
Detect the expression level of miR-185 in salivary and plasma exosomes.Participants were instructed to refrain from eating, drinking, brushing their teeth, rinsing their mouth, or taking medications for one hour before saliva collection. They were then asked to bend over, lower their head, open their mouth, and allow saliva to flow naturally without chewing or spitting. Using a specialized container, 2 mL of unstimulated saliva was collected. Participants fasted overnight before blood collection. Researchers used plasma tubes containing anticoagulant (EDTA) to obtain venous blood (4-5 mL) from the participants\' upper arm. Subsequently, the blood was gently inverted to ensure optimal contact with the anticoagulant before centrifugation at 2000 rpm and 4°C for 10 minutes. Following centrifugation, the supernatant was extracted.	Other	–

Primary outcome

The expression level of miR-185 in salivary exosomes
Time frame: Baseline, pre-biopsy surgery.
Exosomes were isolated from saliva using ultracentrifugation, and total RNA from the exosomes was extracted using TRIzol reagent. Subsequently, the expression level of miR-185 was detected by RT-qPCR.
The expression level of miR-185 in plasma exosomes
Time frame: Baseline, pre-biopsy surgery.
Exosomes were isolated from plasma using ultracentrifugation, and total RNA from the exosomes was extracted using TRIzol reagent. Subsequently, the expression level of miR-185 was detected by RT-qPCR.

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 24 Jun 2024.
Background: PubMed 26316588Jing R, Chen W, Wang H, Ju S, Cong H, Sun B, Jin Q, Chu S, Xu L, Cui M. Plasma miR-185 is decreased in patients with esophageal squamous cell carcinoma and might suppress tumor migration and invasion by targeting RAGE. Am J Physiol Gastrointest Liver Physiol. 2015 Nov 1;309(9):G719-29. doi: 10.1152/ajpgi.00078.2015. Epub 2015 Aug 27.
Background: PubMed 33251978Liu J, Han Y, Liu X, Wei S. Serum miR-185 Is a Diagnostic and Prognostic Biomarker for Non-Small Cell Lung Cancer. Technol Cancer Res Treat. 2020 Jan-Dec;19:1533033820973276. doi: 10.1177/1533033820973276.
Background: PubMed 29454608Zhang W, Sun Z, Su L, Wang F, Jiang Y, Yu D, Zhang F, Sun Z, Liang W. miRNA-185 serves as a prognostic factor and suppresses migration and invasion through Wnt1 in colon cancer. Eur J Pharmacol. 2018 Apr 15;825:75-84. doi: 10.1016/j.ejphar.2018.02.019. Epub 2018 Feb 15.
Background: PubMed 30907490Zhong WQ, Ren JG, Xiong XP, Man QW, Zhang W, Gao L, Li C, Liu B, Sun ZJ, Jia J, Zhang WF, Zhao YF, Chen G. Increased salivary microvesicles are associated with the prognosis of patients with oral squamous cell carcinoma. J Cell Mol Med. 2019 Jun;23(6):4054-4062. doi: 10.1111/jcmm.14291. Epub 2019 Mar 25.
Background: PubMed 38193375Nieuwland R, Siljander PR. A beginner's guide to study extracellular vesicles in human blood plasma and serum. J Extracell Vesicles. 2024 Jan;13(1):e12400. doi: 10.1002/jev2.12400.
Background: PubMed 24009894Witwer KW, Buzas EI, Bemis LT, Bora A, Lasser C, Lotvall J, Nolte-'t Hoen EN, Piper MG, Sivaraman S, Skog J, Thery C, Wauben MH, Hochberg F. Standardization of sample collection, isolation and analysis methods in extracellular vesicle research. J Extracell Vesicles. 2013 May 27;2. doi: 10.3402/jev.v2i0.20360. eCollection 2013.
Background: PubMed 28495994Coumans FAW, Brisson AR, Buzas EI, Dignat-George F, Drees EEE, El-Andaloussi S, Emanueli C, Gasecka A, Hendrix A, Hill AF, Lacroix R, Lee Y, van Leeuwen TG, Mackman N, Mager I, Nolan JP, van der Pol E, Pegtel DM, Sahoo S, Siljander PRM, Sturk G, de Wever O, Nieuwland R. Methodological Guidelines to Study Extracellular Vesicles. Circ Res. 2017 May 12;120(10):1632-1648. doi: 10.1161/CIRCRESAHA.117.309417.
Background: PubMed 31704541Vasconcelos MH, Caires HR, Abols A, Xavier CPR, Line A. Extracellular vesicles as a novel source of biomarkers in liquid biopsies for monitoring cancer progression and drug resistance. Drug Resist Updat. 2019 Dec;47:100647. doi: 10.1016/j.drup.2019.100647. Epub 2019 Oct 15.
Background: PubMed 30951670Jeppesen DK, Fenix AM, Franklin JL, Higginbotham JN, Zhang Q, Zimmerman LJ, Liebler DC, Ping J, Liu Q, Evans R, Fissell WH, Patton JG, Rome LH, Burnette DT, Coffey RJ. Reassessment of Exosome Composition. Cell. 2019 Apr 4;177(2):428-445.e18. doi: 10.1016/j.cell.2019.02.029.
Background: PubMed 33169503Vu LT, Gong J, Pham TT, Kim Y, Le MTN. microRNA exchange via extracellular vesicles in cancer. Cell Prolif. 2020 Nov;53(11):e12877. doi: 10.1111/cpr.12877. Epub 2020 Oct 6.
Background: PubMed 34510546Li B, Cao Y, Sun M, Feng H. Expression, regulation, and function of exosome-derived miRNAs in cancer progression and therapy. FASEB J. 2021 Oct;35(10):e21916. doi: 10.1096/fj.202100294RR.
Background: PubMed 29074454Lu TX, Rothenberg ME. MicroRNA. J Allergy Clin Immunol. 2018 Apr;141(4):1202-1207. doi: 10.1016/j.jaci.2017.08.034. Epub 2017 Oct 23.
Individual participant dataSharing planned: Yes. Data on participants' gender, age, disease duration, lesion characteristics (location and size), tobacco, alcohol and betel nut consumption habits, histopathologic diagnosis, and miR-185 levels in saliva and plasma exosomes will be shared.

Related trials for Oral Leukoplakia

RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Active, not recruitingPhase 2
Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
Erythroplakia, Oral Leukoplakia
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
RecruitingPhase 2
Pembrolizumab in Treating Participants With Leukoplakia
Erythroleukoplakia, Leukoplakia
RecruitingPhase 2
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Oral Leukoplakia

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.

Xiaobing Guan, Ph.D. study director

Beijing Stomatological Hospital, Capital Medical University

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 Oral Leukoplakia and Oral Cancer, run by Beijing Stomatological Hospital, Capital Medical University at 1 site in China.

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 4 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: finished, as of the sponsor's last update on 24 Jun 2024. 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 China. 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?

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?

The expression level of miR-185 in salivary exosomes (time frame: Baseline, pre-biopsy surgery.). The study lists 2 primary outcomes in all. 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 NCT06469892, which also lists 14 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 24 Jun 2024.