Tuberculosis, PulmonaryNCT04055584
PCR Techniques of Dried Sputum Using a Spotcard
An observational study of Tuberculosis, Pulmonary, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Molecular testing for mutations in M. tuberculosis genes associated to resistance of anti tuberculosis (TB) drugs is already part of standard laboratory TB diagnostic. This implicates earlier knowledge of possible resistance and thus prevents unnecessary treatment and the chance of treatment failure or treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- Sputum
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Jul 2019to 31 Dec 2021
- How long will I take part?
- 2 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pulmonary tuberculosis producing sputum
Who may be able to join
- Patients is 18 years or older
- Pulmonary TB confirmed by culture or molecular test
- Producing sputum
- Signed informed consent
Who cannot join
- Extrapulmonary TB
- Pulmonary TB without production of sputum
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen
Onno Akkerman, MD, +31-50-3614902, o.w.akkerman@umcg.nl
Onno Akkerman, MD
About this study
Molecular testing for mutations in M. tuberculosis genes associated to resistance of anti tuberculosis (TB) drugs is already part of standard laboratory TB diagnostic.
This implicates earlier knowledge of possible resistance and thus prevents unnecessary treatment and the chance of treatment failure or treatment related toxicity.
Read more
The molecular laboratory diagnostics is widely spread in high income, low TB endemic countries. However, the low income countries lack widespread facilities to test for susceptibility, either genotypic or phenotypic. Performing molecular diagnostics on sputum collected with a spot card could improve accessibility to molecular testing.
This study examines if sputum collected and put on spot cards could be used for multiple molecular tests for the detection, identification and susceptibility prediction of TB. This means that DNA extraction of the sputum from the spot card should be feasible.
The study is a pilot study with adult patients of the tuberculosis department of University Medical Centre Groningen (UMCG) Beatrixoord, Haren as subjects. The sputum produced will be collected, dried on spot cards, and DNA extraction from the card will be tested. If molecular detection is positive for the tuberculosis bacteria additional tests will be performed. Based on the present/absent of mutations in the genes associated to resistance susceptibility can be preditec, different molecular techniques will be performed to identify possible mutations. Furthermore, sputum will be collected as patients produce so. Sputum samples with low bacterial load can be tested as well and can test the sensitivity of the procedure.
Lastly, techniques like RNA detection will be tested to identify the bacterial load. This can be done if more than one sample of patients were collected.
Subjects will be selected on age, participation in standard TDM and drug use. Demographic parameters will be analysed. Sputum samples will be taken twice a week (on Tuesday and Friday).
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- Sputum
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SputumDiagnostic test
DNA extraction and perform a diversity of molecular diagnostic tests
| Study group | Role | What they receive |
|---|---|---|
| Sputum spot | Not described Receives: Diagnostic Test: Sputum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is it possible to perform a diversity of molecular diagnostic TB tests and in addition new next generation sequencing approaches, with the DNA from the dried sputum spots?
Is it possible to perform a diversity of molecular diagnostic TB tests and in addition new next generation sequencing approaches, with the DNA from the dried sputum spots?
Measured: 6 months
Secondary outcomes (1)
Can we use DNA detection of the sputum from the dried card to certify that in the final utilisation format both the sputum and blood (not collected or tested in this study) are from the same patient?
Can we use DNA detection of the sputum from the dried card to certify that in the final utilisation format both the sputum and blood (not collected or tested in this study) are from the same patient?
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start2 Jul 2019
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onno Akkerman, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055584
- Sponsor's protocol ID
- PCR techniques of dried sputum
- Status last verified
- Apr 2021
- First submitted
- 6 Aug 2019
- Last updated
- 3 May 2021
- 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 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCR Techniques of Dried Sputum Using a Spotcard
- ClinicalTrials.gov ID
- NCT04055584
- Acronym / sponsor ID
- PCR techniques of dried sputum
- Conditions
- Tuberculosis, Pulmonary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 14 Aug 2019 (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.
Molecular testing for mutations in M. tuberculosis genes associated to resistance of anti tuberculosis (TB) drugs is already part of standard laboratory TB diagnostic.
This implicates earlier knowledge of possible resistance and thus prevents unnecessary treatment and the chance of treatment failure or treatment related toxicity.
The molecular laboratory diagnostics is widely spread in high income, low TB endemic countries. However, the low income countries lack widespread facilities to test for susceptibility, either genotypic or phenotypic. Performing molecular diagnostics on sputum collected with a spot card could improve accessibility to molecular testing.
This study examines if sputum collected and put on spot cards could be used for multiple molecular tests for the detection, identification and susceptibility prediction of TB. This means that DNA extraction of the sputum from the spot card should be feasible.
The study is a pilot study with adult patients of the tuberculosis department of University Medical Centre Groningen (UMCG) Beatrixoord, Haren as subjects. The sputum produced will be collected, dried on spot cards, and DNA extraction from the card will be tested. If molecular detection is positive for the tuberculosis bacteria additional tests will be performed. Based on the present/absent of mutations in the genes associated to resistance susceptibility can be preditec, different molecular techniques will be performed to identify possible mutations. Furthermore, sputum will be collected as patients produce so. Sputum samples with low bacterial load can be tested as well and can test the sensitivity of the procedure.
Lastly, techniques like RNA detection will be tested to identify the bacterial load. This can be done if more than one sample of patients were collected.
Subjects will be selected on age, participation in standard TDM and drug use. Demographic parameters will be analysed. Sputum samples will be taken twice a week (on Tuesday and Friday).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sputum spot | – | Diagnostic Test: Sputum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary tuberculosis producing sputum
Key inclusion criteria (4 listed)
- Patients is 18 years or older
- Pulmonary TB confirmed by culture or molecular test
- Producing sputum
- Signed informed consent
Key exclusion criteria (2 listed)
- Extrapulmonary TB
- Pulmonary TB without production of sputum
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 |
|---|---|---|
| SputumDNA extraction and perform a diversity of molecular diagnostic tests | Diagnostic test | Sputum spot |
Primary outcome
Is it possible to perform a diversity of molecular diagnostic TB tests and in addition new next generation sequencing approaches, with the DNA from the dried sputum spots?
Time frame: 6 months
Is it possible to perform a diversity of molecular diagnostic TB tests and in addition new next generation sequencing approaches, with the DNA from the dried sputum spots?
1 secondary outcome
Can we use DNA detection of the sputum from the dried card to certify that in the final utilisation format both the sputum and blood (not collected or tested in this study) are from the same patient?
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- 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.
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, Pulmonary, run by University Medical Center Groningen at 1 site in Netherlands.
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 2 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 3 May 2021. 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 Netherlands. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is it possible to perform a diversity of molecular diagnostic TB tests and in addition new next generation sequencing approaches, with the DNA from the dried sputum spots? (time frame: 6 months). 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 3 May 2021.