Breath TestAVOCADONCT05600608
Augmentation of Volatile Biomarkers of Oesophageal and Gastric Adenocarcinoma From the Tumour Lipidome
A study testing Oral Stimulant Drink in people with Breath Test and Oesophageal Cancer, run by Anuja Mitra at 1 site in United Kingdom.
Trial summary
Nearly 10,000 people die each year in the United Kingdom from cancer of the lower gullet and stomach, known as known as oesophago- gastric adenocarcinoma (OGC). OGC is detected late as symptoms are non- specific and often mistaken for common problems such as heartburn. Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Breath Test, Oesophageal Cancer, Gastric Cancer
- What is being tested?
- Oral Stimulant Drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2022to 20 Dec 2023
- 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 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants should be over 18 years old and up to the maximal age of 90 years , AND:
- Have a confirmed histological diagnosis of oesophageal OR gastric adenocarcinoma at Imperial NHS Healthcare Trust, AND
- Will undergo am oesophagogastroscopy (OGD) as part of their routine clinical care, OR:
- Will undergo surgical resection of their oesophageal or gastric cancer as part of their routine clinical care OR
- Any patient with non- cancerous upper gastrointestinal (benign) problem who will have an OGD OR surgery as part of their routine clinical care at Imperial NHS Trust
Who cannot join
- Participant that lacks capacity or is unable to provide informed consent
- Any participant below 18 years of age or over 90 years of age
- Participants with allergies to any aspect of the metabolic drink
- Participants who have had previous OG surgical resection
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Volatile Biomarker Group, Commonwealth Building, Hammersmith Hospital, Imperial College London
London, W120NN
About this study
Nearly 10,000 people die each year in the United Kingdom from cancer of the lower gullet and stomach, known as known as oesophago- gastric adenocarcinoma (OGC). OGC is detected late as symptoms are non- specific and often mistaken for common problems such as heartburn. This translates to fewer than 2 in every 10 patients diagnosed with OGC living longer than 5 years.
The breath of people with OGC is enriched with volatile chemicals (VOCs) that indicate cancer. When measured in a breath test, it detects OAC 80 out of 100 times. Whilst encouraging, there is scope to improve the detection rate by giving patients a stimulant drink that amplifies the production of tumour specific VOCs only, to increase their detection in the breath test.
Read more
The goal of this observational study is to produce an enhanced second-generation breath test with superior ability to detect OGC through augmentation of breath. This will improve long term survival from cancer using an entirely non- invasive test.
All participants (cancer and control participants) will consume an oral stimulant drink (OSD) and provide breath samples pre and post consumption of the drink at set time points (maximum 2 hours after consumption of the drink).
The investigators will compare the breath VOCs from both groups, before and after consumption of the OSD to see if the OSD has a desired augmentation effect and can improve the accuracy of the OGC breath test.
With this second-generation breath test, participants with vague symptoms can undergo a quick, non- invasive test, have samples analysed in a safe and accurate manner and be subsequently stratified based on their risk of having OGC, leading to earlier disease detection and improved clinical outcomes.
Read the detailed description
Introduction: Early detection of oesophago- gastric adenocarcinoma (OGC) with improved diagnostics is essential to reduce the burden of this aggressive cancer. The breath of people with OAC is enriched with volatile organic compounds (VOC). A breath test based on these VOCs has an 80% sensitivity and 81% specificity of detecting OAC. The diagnostic accuracy may be further improved by using an exogenous stimulant that amplifies the production of OGC specific VOCs. This strategy is known as 'augmentation'. It is possible to compare intra- subject breath (pre and post stimulant) and use the fold increase in VOCs to detect cancer. This is the investigator's novel approach to improving breath test sensitivity and early OGC detection. The biology of the OGC VOCs must be first understood to selectively augment their production.
Background: The OGC lipidome is enriched with phospholipids that are vulnerable to degradation via lipid peroxidation, which is a principal mechanism for endogenous VOC production. Prokaryotic lipids in the OGC microbiome are also vulnerable to peroxidation. Putative drivers of lipid peroxidation are higher in tumour environment. This suggests OGC lipids and/ or prokaryotic lipids may be source compounds for diagnostic VOCs and this mechanism may be augmented.
Aim: to augment the production of OGC VOCs to improve the diagnostic performance of the breath test.
Proposal: 1) A lipidomics study of the onco- microbial lipidome using bespoke mass spectrometry with phenotyping of the corresponding VOCs will identify source lipids that generate diagnostic VOCs, 2) data driven stable isotope experiments to select an augmentation model based on the degradation kinetics of the source lipid in vivo and 3) translating the science to clinic with a study of the augmented breath test in participants with OGC.
Translation of the novel scientific data generated to clinic presents a real opportunity to improve clinical outcomes in people with OGC.
- Conditions
- Breath Test, Oesophageal Cancer, Gastric Cancer, Augmentation, Diagnoses Disease
- Being tested
- Oral Stimulant Drink
- Keywords
- volatile organic compounds, breath test, augmentation, lipid, oesophageal cancer, gastric cancer, non- invasive
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Stimulant DrinkDietary supplement
please see description of the drink in the arm/ group section
| Study group | Role | What they receive |
|---|---|---|
| Oesophago- gastric adenocarcinoma patients | Experimental | Oesophagogastric adenocarcinoma (OG) cancer patients (who are neoadjuvant chemotherapy treatment naïve) will receive 120mls of a sterile oral stimulant drink (OSD) (manufactured by Ingenza ltd), which is an ISO accredited laboratory. The active component of the drink is iron sulphate (5g/l), pH 5-6.
Breath will be taken following an optimised methodology designed by the VOC laboratory at Imperial college London at baseline and then at 30, 60 and 90 minutes following consumption of the drink.
Participants will be nil by mouth for 6 hours prior to the breath test, they can have water up to 2 hours before the breath test. Receives: Dietary Supplement: Oral Stimulant Drink |
| Benign healthy control patients | Active comparator | Age, gender and demographic matched patients who have had a negative oesophagogastroscopy within 1 year which is negative for adenocarcinoma will be recuited into the comparison arm. Patients will be given the same OSD and breath will be sampled at the same time points as the experimental arm. Receives: Dietary Supplement: Oral Stimulant Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish a second- generation augmented breath test with improved diagnostic accuracy for the detection of OG adenocarcinoma.
This breath test will utilise serial breath sampling following the ingestion of an augmentation solution (OSD). Breath samples will be taken pre and post consumption of the OSD and fold changes in the VOCs will be calculated. The entire process of breath sampling is non- invasive.
Measured: 12 months
To determine the diagnostic accuracy of the augmented exhaled breath test, in the prediction of oesophago-gastric cancer (OGC).
The investigators will generate an untargeted VOC breath model following exhaled VOC augmentation.
Measured: 12 months
Secondary outcomes (2)
To comprehensively characterise the tissue lipid input and lipidomic reprogramming in oesophagaeal and gastric adenocarcinoma in comparison to healthy non- cancer tissues.
Liquid chromatography mass spectrometry (LCMS) comprehensive lipidomic OGC tissue profiling will be performed by the investigators to generate a lipid map in healthy and cancer tissues.
Measured: deadline December 2022
To identify the mechanistic pathways and origins of the production of breath Volatile compounds by investigating the tumour lipidome.
The investigators will perform a range of in silico, in vitro and ex vivo experiments that determine the mechanisms and kinetics of lipid to VOC generation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study startNov 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breath TestStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All study participants will receive the same formulation, dose and amount of the oral stimulant drink. Breath samples will be taken at baseline and then at the same time points following consumption of the drink.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anuja Mitra
- Sponsor type
- University, hospital or other
- Collaborators
- British Medical Research Council, British Association of Surgical Oncology, The Royal College of Surgeons of England
- Responsible party
- Sponsor-investigator, Anuja Mitra, Imperial College London
- Investigators
- George B Hanna, FMedSci, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600608
- Sponsor's protocol ID
- 21HH6980
- Acronym
- AVOCADO
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Metabolomic and experimental data will be shared as participants will be given a unique identifier rendering the information anonymous. All other data collated will be stored in a central secure repository under an embargo and will be suitable for sharing following approval by the Chief Investigator. New users can access a simple study policy and summarised data on the Imperial Clinical Research Network study website. Research data will also be discovered on the NIHR In-Vitro Diagnostic Co-operative website. Data will be disseminated through presentation at leading conferences that are accessible to subject specific and generalist audiences. Publication in high impact journals will allow global discovery of data to new users. Decisions to supply research data to new users will be made by: Dr Anuja Mitra, Professor Griffin and Professor Hanna (PI).
Publications
Mitra A, Choi S, Boshier PR, Razumovskaya-Hough A, Belluomo I, Spanel P, Hanna GB. The Human Skin Volatolome: A Systematic Review of Untargeted Mass Spectrometry Analysis. Metabolites. 2022 Sep 1;12(9):824. doi: 10.3390/metabo12090824.
PubMed 36144228Markar SR, Wiggins T, Antonowicz S, Chin ST, Romano A, Nikolic K, Evans B, Cunningham D, Mughal M, Lagergren J, Hanna GB. Assessment of a Noninvasive Exhaled Breath Test for the Diagnosis of Oesophagogastric Cancer. JAMA Oncol. 2018 Jul 1;4(7):970-976. doi: 10.1001/jamaoncol.2018.0991.
PubMed 29799976Antonowicz S, Bodai Z, Wiggins T, Markar SR, Boshier PR, Goh YM, Adam ME, Lu H, Kudo H, Rosini F, Goldin R, Moralli D, Green CM, Peters CJ, Habib N, Gabra H, Fitzgerald RC, Takats Z, Hanna GB. Endogenous aldehyde accumulation generates genotoxicity and exhaled biomarkers in esophageal adenocarcinoma. Nat Commun. 2021 Mar 5;12(1):1454. doi: 10.1038/s41467-021-21800-5.
PubMed 33674602
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Volatile Biomarkers of Oesophageal and Gastric Adenocarcinoma From the Tumour Lipidome
- ClinicalTrials.gov ID
- NCT05600608
- Acronym / sponsor ID
- AVOCADO / 21HH6980
- Conditions
- Breath Test, Oesophageal Cancer, Gastric Cancer, Augmentation, Diagnoses Disease
- Keywords
- volatile organic compounds, breath test, augmentation, lipid, oesophageal cancer, gastric cancer, non- invasive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anuja MitraUniversity, hospital or other
- Collaborators
- British Medical Research Council, British Association of Surgical Oncology, The Royal College of Surgeons of England
- Study start
- Nov 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 31 Oct 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.
Nearly 10,000 people die each year in the United Kingdom from cancer of the lower gullet and stomach, known as known as oesophago- gastric adenocarcinoma (OGC). OGC is detected late as symptoms are non- specific and often mistaken for common problems such as heartburn. This translates to fewer than 2 in every 10 patients diagnosed with OGC living longer than 5 years.
The breath of people with OGC is enriched with volatile chemicals (VOCs) that indicate cancer. When measured in a breath test, it detects OAC 80 out of 100 times. Whilst encouraging, there is scope to improve the detection rate by giving patients a stimulant drink that amplifies the production of tumour specific VOCs only, to increase their detection in the breath test.
The goal of this observational study is to produce an enhanced second-generation breath test with superior ability to detect OGC through augmentation of breath. This will improve long term survival from cancer using an entirely non- invasive test.
All participants (cancer and control participants) will consume an oral stimulant drink (OSD) and provide breath samples pre and post consumption of the drink at set time points (maximum 2 hours after consumption of the drink).
The investigators will compare the breath VOCs from both groups, before and after consumption of the OSD to see if the OSD has a desired augmentation effect and can improve the accuracy of the OGC breath test.
With this second-generation breath test, participants with vague symptoms can undergo a quick, non- invasive test, have samples analysed in a safe and accurate manner and be subsequently stratified based on their risk of having OGC, leading to earlier disease detection and improved clinical outcomes.
Detailed description
Introduction: Early detection of oesophago- gastric adenocarcinoma (OGC) with improved diagnostics is essential to reduce the burden of this aggressive cancer. The breath of people with OAC is enriched with volatile organic compounds (VOC). A breath test based on these VOCs has an 80% sensitivity and 81% specificity of detecting OAC. The diagnostic accuracy may be further improved by using an exogenous stimulant that amplifies the production of OGC specific VOCs. This strategy is known as 'augmentation'. It is possible to compare intra- subject breath (pre and post stimulant) and use the fold increase in VOCs to detect cancer. This is the investigator's novel approach to improving breath test sensitivity and early OGC detection. The biology of the OGC VOCs must be first understood to selectively augment their production.
Background: The OGC lipidome is enriched with phospholipids that are vulnerable to degradation via lipid peroxidation, which is a principal mechanism for endogenous VOC production. Prokaryotic lipids in the OGC microbiome are also vulnerable to peroxidation. Putative drivers of lipid peroxidation are higher in tumour environment. This suggests OGC lipids and/ or prokaryotic lipids may be source compounds for diagnostic VOCs and this mechanism may be augmented.
Aim: to augment the production of OGC VOCs to improve the diagnostic performance of the breath test.
Proposal: 1) A lipidomics study of the onco- microbial lipidome using bespoke mass spectrometry with phenotyping of the corresponding VOCs will identify source lipids that generate diagnostic VOCs, 2) data driven stable isotope experiments to select an augmentation model based on the degradation kinetics of the source lipid in vivo and 3) translating the science to clinic with a study of the augmented breath test in participants with OGC.
Translation of the novel scientific data generated to clinic presents a real opportunity to improve clinical outcomes in people with OGC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All study participants will receive the same formulation, dose and amount of the oral stimulant drink. Breath samples will be taken at baseline and then at the same time points following consumption of the drink.
| Arm | Type | Receives |
|---|---|---|
| Oesophago- gastric adenocarcinoma patients | Experimental | Dietary Supplement: Oral Stimulant DrinkOesophagogastric adenocarcinoma (OG) cancer patients (who are neoadjuvant chemotherapy treatment naïve) will receive 120mls of a sterile oral stimulant drink (OSD) (manufactured by Ingenza ltd), which is an ISO accredited laboratory. The active component of the drink is iron sulphate (5g/l), pH 5-6. Breath will be taken following an optimised methodology designed by the VOC laboratory at Imperial college London at baseline and then at 30, 60 and 90 minutes following consumption of the drink. Participants will be nil by mouth for 6 hours prior to the breath test, they can have water up to 2 hours before the breath test. |
| Benign healthy control patients | Active comparator | Dietary Supplement: Oral Stimulant DrinkAge, gender and demographic matched patients who have had a negative oesophagogastroscopy within 1 year which is negative for adenocarcinoma will be recuited into the comparison arm. Patients will be given the same OSD and breath will be sampled at the same time points as the experimental arm. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants should be over 18 years old and up to the maximal age of 90 years , AND:
- Have a confirmed histological diagnosis of oesophageal OR gastric adenocarcinoma at Imperial NHS Healthcare Trust, AND
- Will undergo am oesophagogastroscopy (OGD) as part of their routine clinical care, OR:
- Will undergo surgical resection of their oesophageal or gastric cancer as part of their routine clinical care OR
- Any patient with non- cancerous upper gastrointestinal (benign) problem who will have an OGD OR surgery as part of their routine clinical care at Imperial NHS Trust
Key exclusion criteria (4 listed)
- Participant that lacks capacity or is unable to provide informed consent
- Any participant below 18 years of age or over 90 years of age
- Participants with allergies to any aspect of the metabolic drink
- Participants who have had previous OG surgical resection
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 |
|---|---|---|
| Oral Stimulant Drinkplease see description of the drink in the arm/ group section | Dietary supplement | Benign healthy control patients, Oesophago- gastric adenocarcinoma patients |
Primary outcome
To establish a second- generation augmented breath test with improved diagnostic accuracy for the detection of OG adenocarcinoma.
Time frame: 12 months
This breath test will utilise serial breath sampling following the ingestion of an augmentation solution (OSD). Breath samples will be taken pre and post consumption of the OSD and fold changes in the VOCs will be calculated. The entire process of breath sampling is non- invasive.
To determine the diagnostic accuracy of the augmented exhaled breath test, in the prediction of oesophago-gastric cancer (OGC).
Time frame: 12 months
The investigators will generate an untargeted VOC breath model following exhaled VOC augmentation.
2 secondary outcomes
To comprehensively characterise the tissue lipid input and lipidomic reprogramming in oesophagaeal and gastric adenocarcinoma in comparison to healthy non- cancer tissues.
Time frame: deadline December 2022
To identify the mechanistic pathways and origins of the production of breath Volatile compounds by investigating the tumour lipidome.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Background: PubMed 36144228Mitra A, Choi S, Boshier PR, Razumovskaya-Hough A, Belluomo I, Spanel P, Hanna GB. The Human Skin Volatolome: A Systematic Review of Untargeted Mass Spectrometry Analysis. Metabolites. 2022 Sep 1;12(9):824. doi: 10.3390/metabo12090824.
- Results publication: PubMed 29799976Markar SR, Wiggins T, Antonowicz S, Chin ST, Romano A, Nikolic K, Evans B, Cunningham D, Mughal M, Lagergren J, Hanna GB. Assessment of a Noninvasive Exhaled Breath Test for the Diagnosis of Oesophagogastric Cancer. JAMA Oncol. 2018 Jul 1;4(7):970-976. doi: 10.1001/jamaoncol.2018.0991.
- Results publication: PubMed 33674602Antonowicz S, Bodai Z, Wiggins T, Markar SR, Boshier PR, Goh YM, Adam ME, Lu H, Kudo H, Rosini F, Goldin R, Moralli D, Green CM, Peters CJ, Habib N, Gabra H, Fitzgerald RC, Takats Z, Hanna GB. Endogenous aldehyde accumulation generates genotoxicity and exhaled biomarkers in esophageal adenocarcinoma. Nat Commun. 2021 Mar 5;12(1):1454. doi: 10.1038/s41467-021-21800-5.
- Individual participant dataSharing planned: Yes. Metabolomic and experimental data will be shared as participants will be given a unique identifier rendering the information anonymous. All other data collated will be stored in a central secure repository under an embargo and will be suitable for sharing following approval by the Chief Investigator. New users can access a simple study policy and summarised data on the Imperial Clinical Research Network study website. Research data will also be discovered on the NIHR In-Vitro Diagnostic Co-operative website. Data will be disseminated through presentation at leading conferences that are accessible to subject specific and generalist audiences. Publication in high impact journals will allow global discovery of data to new users. Decisions to supply research data to new users will be made by: Dr Anuja Mitra, Professor Griffin and Professor Hanna (PI).
Related trials for Breath Test
Enrolling by invitationPhase 2
Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
Not yet recruitingObservational study
Real-Time Breath Analysis in Acute Myeloid Leukaemia for a Rapid Characterisation of Biological Subtypes and to Predict Therapy Responses
AML
Not yet recruiting
Pylori Duo for Adjunctive Treatment and Prevention of Recurrence of Helicobacter Pylori Infection
Helicobacter Pylori Infection, Dyspepsia
RecruitingObservational study
Helicobacter Pylori Infection Status and Pathological Features for Predicting Gastric Cancer Biological Behavior and Prognosis: A Real-World Observational Study
Helicobacter Pylori, Early Gastric Cancer
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.
George B Hanna, FMedSci principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Stimulant Drink in people with Breath Test and Oesophageal Cancer, run by Anuja Mitra at 1 site in United Kingdom.
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 5 inclusion and 4 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 2 Nov 2022. 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 United Kingdom. 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 Anuja T Mitra, MBBS, BSc (07545980633, anuja.mitra06@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish a second- generation augmented breath test with improved diagnostic accuracy for the detection of OG adenocarcinoma. (time frame: 12 months). 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 NCT05600608, which also lists 3 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 2 Nov 2022.