TuberculosisNCT04490746
Identifcation of Biomarkers for Active Pulmonary Tuberculosis
An observational study of Tuberculosis and Diagnosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This experiment is designed to analyze the metabolites in body fluids from patients with active tuberculosis and latent tuberculosis infection also with health volunteer, then combine the metabolic product features with clinical characteristics, to develop a kind of metabolites targets to evaluate the progress in… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Diagnosis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 1 Oct 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with active tuberculosis and latent tuberculosis infection
Who may be able to join
- patients with active tuberculosis and latent tuberculosis infection
Who cannot join
- have other serious health problems
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 0571
About this study
Official title: Identifcation of Biomarkers for Active Pulmonary Tuberculosis Using a Metabolomics Approach: a Prospective Multicenter Study
This experiment is designed to analyze the metabolites in body fluids from patients with active tuberculosis and latent tuberculosis infection also with health volunteer, then combine the metabolic product features with clinical characteristics, to develop a kind of metabolites targets to evaluate the progress in tuberculosis, thus provide a basis for further utilization of humoral metabolites in the diagnosis of tuberculosis.
- Conditions
- Tuberculosis, Diagnosis
- Being tested
- with no intervention, Collect samples
- Medical subject headings
- Tuberculosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with no intervention, Collect samplesOther
only with observation,there is no need to intervene
| Study group | Role | What they receive |
|---|---|---|
| active | patients with active tuberculosis Receives: Other: with no intervention, Collect samples | |
| latent | patients with latent tuberculosis infection Receives: Other: with no intervention, Collect samples | |
| negtive control | healthy volunteers Receives: Other: with no intervention, Collect samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic product
features up-regulated or down-regulated
Measured: 24 hours after sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pintong Huang, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490746
- Sponsor's protocol ID
- 研2020-556
- Status last verified
- Jul 2020
- First submitted
- 26 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data (IPD) can be shared after the main unit publish articals
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifcation of Biomarkers for Active Pulmonary Tuberculosis Using a Metabolomics Approach: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT04490746
- Acronym / sponsor ID
- 研2020-556
- Conditions
- Tuberculosis, Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 29 Jul 2020 (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.
This experiment is designed to analyze the metabolites in body fluids from patients with active tuberculosis and latent tuberculosis infection also with health volunteer, then combine the metabolic product features with clinical characteristics, to develop a kind of metabolites targets to evaluate the progress in tuberculosis, thus provide a basis for further utilization of humoral metabolites in the diagnosis of tuberculosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active | – | Other: with no intervention, Collect samplespatients with active tuberculosis |
| latent | – | Other: with no intervention, Collect samplespatients with latent tuberculosis infection |
| negtive control | – | Other: with no intervention, Collect sampleshealthy volunteers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with active tuberculosis and latent tuberculosis infection
Key inclusion criteria (1 listed)
- patients with active tuberculosis and latent tuberculosis infection
Key exclusion criteria (1 listed)
- have other serious health problems
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 |
|---|---|---|
| with no intervention, Collect samplesonly with observation,there is no need to intervene | Other | active, latent, negtive control |
Primary outcome
metabolic product
Time frame: 24 hours after sampling
features up-regulated or down-regulated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: Yes. individual participant data (IPD) can be shared after the main unit publish articals
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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.
Pintong Huang principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Tuberculosis and Diagnosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 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 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yajing Liu (18358152521, liuyajingyyyyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolic product (time frame: 24 hours after sampling). 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 29 Jul 2020.