Microbial ColonizationNCT03545542
Investigating the Microbiome and Volatile Organic Compound Profile of Children With Neuroblastoma
A study testing Initial fecal microbiome, Initial fecal volatile organic compounds and Initial breath volatile organic compounds in people with Microbial Colonization and Neuroblastoma, run by Medical University of Graz at 1 site in Austria.
Trial summary
Background: Malignant tumors may lead to a catabolic state with loss of muscle and adipose tissue. The full picture of catabolism is termed cachexia and is associated with significant morbidity and mortality of cancer patients. Read more about this study
- Who is it for?
- Ages 1 month to 8 years
- Conditions the study is for
- Microbial Colonization, Neuroblastoma, Children, Only
- What is being tested?
- Initial fecal microbiome, Initial fecal volatile organic compounds and Initial breath volatile organic compounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 7 May 2018to 31 Dec 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 1 month to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2-8 years
- Neuroblastoma group: verified neuroblastoma
- Control group: absence of pulmonary or gastro-intestinal disease
- Written parental informed consent obtained
Who cannot join
- Active gastro-intestinal or pulmonary disease
- Antibiotic or probiotic treatment within 3 weeks before sampling
- Negative parental informed consent
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria
Graz, Styria, 8036
Christoph Castellani, MD, +43/316/385 ext. 80217, christoph.castellani@medunigraz.at
Daniela Sperl, MD
About this study
Official title: Investigating the Microbiome and Volatile Organic Compound Profile of Children With Neuroblastoma - a Pilot Study
Background: Malignant tumors may lead to a catabolic state with loss of muscle and adipose tissue. The full picture of catabolism is termed cachexia and is associated with significant morbidity and mortality of cancer patients. Although the full picture is rarely observed up to 50% of children with cancer suffer from significant malnourishment. Additionally to tumor-induced catabolism, side-effects of chemotherapy may be problematic for the patients. In this regard up to 60% of children suffer from gastrointestinal mucositis presenting with nausea, vomiting, diarrhea or constipation and abdominal pain. In the worst case, mucositis may lead to bacterial translocation with life-threatening inflammatory response. Clinically this may require a reduction of the dosage or the number of chemotherapy cycles resulting in reduced effectivity. Up to now the therapy of mucositis is only symptomatic. Recent research of the applicant has shown a significant reduction of Lactobacilli in mice with neuroblastoma (a malignant childhood tumor). The dysbiosis was associated with catabolism, increased gut permeability and inflammation. Astonishingly, chemotherapy alone also leads to a significant reduction of Lactobacilli compared to sham mice, which may be linked to the development of mucositis clinically. Overall, the intestinal microbiome seems to play an essential role in the development of tumor-associated catabolism and chemotherapy-induced mucositis.
Aim: The aim of this project is to determine if the changes in the intestinal microbiome observed in mice can also be seen in children with neuroblastoma.
Read more
Methods: One part of the study will include 10 children with neuroblastoma (inclusion after verification of the diagnosis) and 10 healthy controls. The fecal microbiome will be determined by 16S-ribosomal deoxyribonucleic acid (rDNA) pyrosequencing. Volatile organic compounds in the breath will be sampled and measured by Gas Chromatography/Mass Spectroscopy. A basic science human work package will address the question if there are differences.
In the second part serial investigations in children with neuroblastoma will assess whether or not these patients show alterations of the intestinal microbiome under chemotherapy.
- Conditions
- Microbial Colonization, Neuroblastoma, Children, Only
- Being tested
- Initial fecal microbiome, Initial fecal volatile organic compounds, Initial breath volatile organic compounds, Microbiome under chemotherapy, Fecal volatile organic compounds under chemotherapy
- Keywords
- Microbiome, Volatile organic compounds, Neuroblastoma
- Medical subject headings
- Communicable Diseases, Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial fecal microbiomeDiagnostic test
Stool sampling for fecal microbiome analysis by 16S rDNA pyrosequencing. Neuroblastoma group and Control group.
Initial fecal volatile organic compoundsDiagnostic test
Volatile organic compound analysis of stool samples by gas chromatography/mass spectroscopy Neuroblastoma group and Control group.
Initial breath volatile organic compoundsDiagnostic test
Breath sampling for organic compound analysis by gas chromatography/mass spectroscopy Neuroblastoma group and Control group.
Microbiome under chemotherapyDiagnostic test
Stool sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to Société Internationale d´Onclogie Pediatrique Neuroblastoma Group (SIOPEN) guidelines
Fecal volatile organic compounds under chemotherapyDiagnostic test
Stool sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to SIOPEN guidelines.
Neuroblastoma group
Breath volatile organic compounds under chemotherapyDiagnostic test
Breath sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to SIOPEN guidelines.
Neuroblastoma group
Final microbiomeDiagnostic test
Stool sampling 3 weeks after completion of chemotherapy Neuroblastoma group
Final fecal volatile organic compoundsDiagnostic test
Stool sampling 3 weeks after completion of chemotherapy Neuroblastoma group
Final breath volatile organic compoundsDiagnostic test
Breath sampling 3 weeks after completion of chemotherapy Neuroblastoma group
| Study group | Role | What they receive |
|---|---|---|
| Neuroblastoma group | Experimental | 10 children with neuroblastoma. Inclusion after verification of diagnosis and informed consent.
Sampling of fecal microbiome (Initial microbiome, microbiome under chemotherapy, final microbiome), fecal volatile organic compounds (initial fecal volatile organic compounds, fecal volatile organic compounds under chemotherapy and final fecal volatile organic compounds) and breath organic volatile compounds (initial breath organic compounds, breath volatile organic compounds under chemotherapy and final breath volatile organic compounds).
Samples will be taken after verifying diagnosis before initiation of chemotherapy, 1 week after completion of each cycle and 3 weeks after the end of chemotherapy. Receives: Diagnostic Test: Initial fecal microbiome; Diagnostic Test: Initial fecal volatile organic compounds; Diagnostic Test: Initial breath volatile organic compounds; Diagnostic Test: Microbiome under chemotherapy; Diagnostic Test: Fecal volatile organic compounds under chemotherapy; Diagnostic Test: Breath volatile organic compounds under chemotherapy; Diagnostic Test: Final microbiome; Diagnostic Test: Final fecal volatile organic compounds; Diagnostic Test: Final breath volatile organic compounds |
| Control group | Other | 10 children without gastro-intestinal or pulmonary disease as age and sex matched controls to the neuroblastoma group. Patients will be recruited from paediatric surgery. Inclusion after informed consent.
Sampling of fecal microbiome (initial fecal microbiome), fecal volatile organic compounds (initial fecal volatile organic compounds) and breath organic volatile compounds (initial breath volatile organic compounds).
Samples will be taken as age and sex matched controls for the neuroblastoma group. Sampling will be done once after obtaining informed consent. Receives: Diagnostic Test: Initial fecal microbiome; Diagnostic Test: Initial fecal volatile organic compounds; Diagnostic Test: Initial breath volatile organic compounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of alpha and beta diversity, relative abundance of fecal bacteria at different levels (phylum, class, order, family and genus levels) between neuroblastoma and control group
Alpha and beta diversity, relative bacterial abundance at different levels in percent.
Measured: Neuroblastoma group: within 48h after diagnosis, before initiation of chemotherapy. Control group: within 24h after obtaining informed consent.
Change of alpha and beta diversity, relative abundance of fecal bacteria at different levels (phylum, class, order, family and genus levels) under chemotherapy in the neuroblastoma group
Alpha and beta diversity, relative bacterial abundance at different levels in percent.
Measured: Within 48h after diagnosis, before initiation of chemotherapy; 1 week after each chemotherapy cycle and 3 weeks after the end of chemotherapy.
Secondary outcomes (7)
Difference of anthropometric data between neuroblastoma and control group.
Body weight (in kg) and height (in m) will be determined to calculate the body mass index (BMI in kg/m^2).
Measured: Neuroblastoma group: within 48h after diagnosis. Control group: within 24h after obtaining informed consent.
Change of anthropometric data under chemotherapy in the neuroblastoma group
Body weight (in kg) and height (in m) will be determined to calculate the Body mass index (BMI in kg/m^2).
Measured: Within 48h after diagnosis, before initiation of chemotherapy; 7 days after completion of each chemotherapy cycle and 3 weeks after the end of chemotherapy.
Change of mucositis score under chemotherapy in the neuroblastoma group.
Assessment of the mucositis score according to the WHO criteria (WHO handbook for reporting results of cancer Treatment; WHO Offset publication no 48) The score contains 5 subitems which are evaluated separately. At the end a total score is derived by adding the results of all items.
Subitem 1: oral mucosa; range 0 (best) to 4 (worst) Subitem 2: nausea and vomiting; range from 0 (best) to 4 (worst) Subitem 3: diarrhea; range from 0 (best) to 4 (worst) Subitem 4: constipation; range from 0 (best) to 4 (worst) Subitem 5: abdominal pain; range from 0 (best) to 4 (worst)
Measured: Within 48h after diagnosis, before initiation of chemotherapy; 7 days after completion of each chemotherapy cycle and 3 weeks after the end of chemotherapy.
Difference of breath volatile organic compounds between neuroblastoma and control group.
Volatile organic compounds in ppb in the exhaled breath.
Measured: Neuroblastoma group: within 48h after diagnosis. Control group: within 24h after obtaining informed consent.
Difference of stool volatile organic compounds between neuroblastoma and control group.
Volatile organic compounds in ppb in stool samples.
Measured: Neuroblastoma group: within 48h after diagnosis. Control group: within 24h after obtaining informed consent.
Change of breath volatile organic compounds under chemotherapy in the neuroblastoma group.
Volatile organic compounds in ppb in the exhaled breath.
Measured: Within 48h after diagnosis, before initiation of chemotherapy; 1 week after each chemotherapy cycle and 3 weeks after the end of chemotherapy.
Change of stool volatile organic compounds under chemotherapy in the neuroblastoma group.
Volatile organic compounds in ppb in stool samples.
Measured: Within 48h after diagnosis, before initiation of chemotherapy; 1 week after each chemotherapy cycle and 3 weeks after the end of chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start7 May 2018
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Neuroblastoma group: Children with neuroblastoma enrolled after verification of diagnosis. Sampling before initiation of chemotherapy and under chemotherapy. Control group: healthy children without gastro-intestinal or pulmonary disease recruited from paediatric surgery.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Castellani, MD, Principal investigator, Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545542
- Sponsor's protocol ID
- 0001
- Status last verified
- Feb 2020
- First submitted
- 7 May 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Microbiome and Volatile Organic Compound Profile of Children With Neuroblastoma - a Pilot Study
- ClinicalTrials.gov ID
- NCT03545542
- Acronym / sponsor ID
- 0001
- Conditions
- Microbial Colonization, Neuroblastoma, Children, Only
- Keywords
- Microbiome, Volatile organic compounds, Neuroblastoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Jun 2018 (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: Malignant tumors may lead to a catabolic state with loss of muscle and adipose tissue. The full picture of catabolism is termed cachexia and is associated with significant morbidity and mortality of cancer patients. Although the full picture is rarely observed up to 50% of children with cancer suffer from significant malnourishment. Additionally to tumor-induced catabolism, side-effects of chemotherapy may be problematic for the patients. In this regard up to 60% of children suffer from gastrointestinal mucositis presenting with nausea, vomiting, diarrhea or constipation and abdominal pain. In the worst case, mucositis may lead to bacterial translocation with life-threatening inflammatory response. Clinically this may require a reduction of the dosage or the number of chemotherapy cycles resulting in reduced effectivity. Up to now the therapy of mucositis is only symptomatic. Recent research of the applicant has shown a significant reduction of Lactobacilli in mice with neuroblastoma (a malignant childhood tumor). The dysbiosis was associated with catabolism, increased gut permeability and inflammation. Astonishingly, chemotherapy alone also leads to a significant reduction of Lactobacilli compared to sham mice, which may be linked to the development of mucositis clinically. Overall, the intestinal microbiome seems to play an essential role in the development of tumor-associated catabolism and chemotherapy-induced mucositis.
Aim: The aim of this project is to determine if the changes in the intestinal microbiome observed in mice can also be seen in children with neuroblastoma.
Methods: One part of the study will include 10 children with neuroblastoma (inclusion after verification of the diagnosis) and 10 healthy controls. The fecal microbiome will be determined by 16S-ribosomal deoxyribonucleic acid (rDNA) pyrosequencing. Volatile organic compounds in the breath will be sampled and measured by Gas Chromatography/Mass Spectroscopy. A basic science human work package will address the question if there are differences.
In the second part serial investigations in children with neuroblastoma will assess whether or not these patients show alterations of the intestinal microbiome under chemotherapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Neuroblastoma group: Children with neuroblastoma enrolled after verification of diagnosis. Sampling before initiation of chemotherapy and under chemotherapy. Control group: healthy children without gastro-intestinal or pulmonary disease recruited from paediatric surgery.
| Arm | Type | Receives |
|---|---|---|
| Neuroblastoma group | Experimental | Diagnostic Test: Initial fecal microbiome, Diagnostic Test: Initial fecal volatile organic compounds, Diagnostic Test: Initial breath volatile organic compounds, Diagnostic Test: Microbiome under chemotherapy, Diagnostic Test: Fecal volatile organic compounds under chemotherapy, Diagnostic Test: Breath volatile organic compounds under chemotherapy, Diagnostic Test: Final microbiome, Diagnostic Test: Final fecal volatile organic compounds, Diagnostic Test: Final breath volatile organic compounds10 children with neuroblastoma. Inclusion after verification of diagnosis and informed consent. Sampling of fecal microbiome (Initial microbiome, microbiome under chemotherapy, final microbiome), fecal volatile organic compounds (initial fecal volatile organic compounds, fecal volatile organic compounds under chemotherapy and final fecal volatile organic compounds) and breath organic volatile compounds (initial breath organic compounds, breath volatile organic compounds under chemotherapy and final breath volatile organic compounds). Samples will be taken after verifying diagnosis before initiation of chemotherapy, 1 week after completion of each cycle and 3 weeks after the end of chemotherapy. |
| Control group | Other | Diagnostic Test: Initial fecal microbiome, Diagnostic Test: Initial fecal volatile organic compounds, Diagnostic Test: Initial breath volatile organic compounds10 children without gastro-intestinal or pulmonary disease as age and sex matched controls to the neuroblastoma group. Patients will be recruited from paediatric surgery. Inclusion after informed consent. Sampling of fecal microbiome (initial fecal microbiome), fecal volatile organic compounds (initial fecal volatile organic compounds) and breath organic volatile compounds (initial breath volatile organic compounds). Samples will be taken as age and sex matched controls for the neuroblastoma group. Sampling will be done once after obtaining informed consent. |
Who may qualify
- Ages
- 1 month to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 2-8 years
- Neuroblastoma group: verified neuroblastoma
- Control group: absence of pulmonary or gastro-intestinal disease
- Written parental informed consent obtained
Key exclusion criteria (3 listed)
- Active gastro-intestinal or pulmonary disease
- Antibiotic or probiotic treatment within 3 weeks before sampling
- Negative parental 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 |
|---|---|---|
| Initial fecal microbiomeStool sampling for fecal microbiome analysis by 16S rDNA pyrosequencing. Neuroblastoma group and Control group. | Diagnostic test | Control group, Neuroblastoma group |
| Initial fecal volatile organic compoundsVolatile organic compound analysis of stool samples by gas chromatography/mass spectroscopy Neuroblastoma group and Control group. | Diagnostic test | Control group, Neuroblastoma group |
| Initial breath volatile organic compoundsBreath sampling for organic compound analysis by gas chromatography/mass spectroscopy Neuroblastoma group and Control group. | Diagnostic test | Control group, Neuroblastoma group |
| Microbiome under chemotherapyStool sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to Société Internationale d´Onclogie Pediatrique Neuroblastoma Group (SIOPEN) guidelines | Diagnostic test | Neuroblastoma group |
| Fecal volatile organic compounds under chemotherapyStool sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to SIOPEN guidelines. Neuroblastoma group | Diagnostic test | Neuroblastoma group |
| Breath volatile organic compounds under chemotherapyBreath sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to SIOPEN guidelines. Neuroblastoma group | Diagnostic test | Neuroblastoma group |
| Final microbiomeStool sampling 3 weeks after completion of chemotherapy Neuroblastoma group | Diagnostic test | Neuroblastoma group |
| Final fecal volatile organic compoundsStool sampling 3 weeks after completion of chemotherapy Neuroblastoma group | Diagnostic test | Neuroblastoma group |
| Final breath volatile organic compoundsBreath sampling 3 weeks after completion of chemotherapy Neuroblastoma group | Diagnostic test | Neuroblastoma group |
Primary outcome
Difference of alpha and beta diversity, relative abundance of fecal bacteria at different levels (phylum, class, order, family and genus levels) between neuroblastoma and control group
Time frame: Neuroblastoma group: within 48h after diagnosis, before initiation of chemotherapy. Control group: within 24h after obtaining informed consent.
Alpha and beta diversity, relative bacterial abundance at different levels in percent.
Change of alpha and beta diversity, relative abundance of fecal bacteria at different levels (phylum, class, order, family and genus levels) under chemotherapy in the neuroblastoma group
Time frame: Within 48h after diagnosis, before initiation of chemotherapy; 1 week after each chemotherapy cycle and 3 weeks after the end of chemotherapy.
Alpha and beta diversity, relative bacterial abundance at different levels in percent.
7 secondary outcomes
Difference of anthropometric data between neuroblastoma and control group.
Time frame: Neuroblastoma group: within 48h after diagnosis. Control group: within 24h after obtaining informed consent.
Change of anthropometric data under chemotherapy in the neuroblastoma group
Time frame: Within 48h after diagnosis, before initiation of chemotherapy; 7 days after completion of each chemotherapy cycle and 3 weeks after the end of chemotherapy.
Change of mucositis score under chemotherapy in the neuroblastoma group.
Time frame: Within 48h after diagnosis, before initiation of chemotherapy; 7 days after completion of each chemotherapy cycle and 3 weeks after the end of chemotherapy.
Difference of breath volatile organic compounds between neuroblastoma and control group.
Time frame: Neuroblastoma group: within 48h after diagnosis. Control group: within 24h after obtaining informed consent.
Difference of stool volatile organic compounds between neuroblastoma and control group.
Time frame: Neuroblastoma group: within 48h after diagnosis. Control group: within 24h after obtaining informed consent.
Change of breath volatile organic compounds under chemotherapy in the neuroblastoma group.
Time frame: Within 48h after diagnosis, before initiation of chemotherapy; 1 week after each chemotherapy cycle and 3 weeks after the end of chemotherapy.
Change of stool volatile organic compounds under chemotherapy in the neuroblastoma group.
Time frame: Within 48h after diagnosis, before initiation of chemotherapy; 1 week after each chemotherapy cycle and 3 weeks after the end of chemotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Christoph Castellani, MD principal investigator
Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial fecal microbiome, Initial fecal volatile organic compounds and Initial breath volatile organic compounds in people with Microbial Colonization and Neuroblastoma, run by Medical University of Graz at 1 site in Austria.
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 3 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 25 Feb 2020. 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 Austria. 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 Christoph Castellani, MD (+43/316/385 ext. 80217, christoph.castellani@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of alpha and beta diversity, relative abundance of fecal bacteria at different levels (phylum, class, order, family and genus levels) between neuroblastoma and control group (time frame: Neuroblastoma group: within 48h after diagnosis, before initiation of chemotherapy. Control group: within 24h after obtaining informed consent.). 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?
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 25 Feb 2020.