An observational study in Tuberculosis and Latent Tuberculosis, sponsored by Public Health England. Completed at 3 sites in United Kingdom. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-01.
Sponsored by Public Health England · Observational
Among 13 studies in Latent Tuberculosis with a site in United Kingdom — 3 open to participants now, 3 under way, none of them phase 3. Latent Tuberculosis · United Kingdom.
Among the 13 studies in Latent Tuberculosis with a site in United Kingdom, this one is the only one that started in 2010, is one of 9 observational ones, and was the 3rd registered.
199 studies on the registry are indexed under Latent Tuberculosis; 48 are open to participants now.
This study's enrollment of 10,000 is above the median of 260 across 82 observational studies indexed under Latent Tuberculosis.
Browse Latent Tuberculosis studies →3 of the 13 studies in Latent Tuberculosis with a site in United Kingdom are open now, in 1 country. Each count lists the studies.
Of the 29 Latent Tuberculosis studies recruiting now, 15 (52%) set no upper age limit and 12 (41%) stop at 75 or younger; 15 take children under 18; 7 take healthy volunteers.
This study: 16 Years and older · all sexes · healthy volunteers too.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2010.
Median enrollment 270 across the 4 interventional studies, 1,000 across the 9 observational. Of the 8 that completed or were terminated, 1 (13%) have results posted.
1 of 13 have an industry lead sponsor. The 8 most frequent:
Public Health England is the lead sponsor of 37 studies on the registry; none are open to participants now.
Public Health England has 2 studies filed under Latent Tuberculosis — fewer than ten, so there is no comparison to draw.
1 of the studies in Latent Tuberculosis with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07024836University College, LondonPRecision biomArker-Guided MAnagement of TuberculosIs Contacts: a Discrete Choice Experiment | 2026-12 |
Among the 13 studies in Latent Tuberculosis with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
The objective of this study is to assess the efficacy of the two current TB (tuberculosis) blood tests (Interferon Gamma Release Assays (IGRA)) compared with the standard skin test (Mantoux Tuberculin Skin Test (TST)), for predicting active tuberculosis among those at increased risk of TB. Those at increased risk are defined as either newly arrived immigrants or people who have been in contact with TB cases. The study will also provide information on the cost effectiveness of different testing strategies, such as the two step testing approach recommended by NICE. The study is to be funded by the NIHR Health Technology Assessment programme.
10,000 participants will be recruited from 12 hospitals and a network of GP surgeries in London. All participants will have the skin test and blood taken for both assays. Disease status of participants will then be followed up for an average of 24 months using the national register of clinical reports, a phone call and the national microbiological database. The risk of developing active disease is highest in the first two years after exposure. During followup there will be no additional diagnostic procedures unless symptoms occur, i.e. in line with current NICE policy. A sub group of patients, selected as a random 25% of participants, will have a repeat IGRA test shortly after the first test to investigate whether the skin test affects the result of the blood test.
DESIGN: Prospective cohort study of individuals (> or = 16 yrs) who are: (a) close contacts of TB cases or (b) new entrants from high incidence countries (>40/100000). SETTING: London TB clinics. NE London TB Network Primary Care Practices. All study sites will be coordinated from the HPA Centre for Infections.
HEALTH TECHNOLOGIES (LTBI MEASURES):Participants will be tested by Mantoux TST and two IGRA tests(Quantiferon-Gold In Tube ELISA) and ELISpot assay (same as Tspot.TB). A 25ml blood specimen will be collected with the residuum, after IGRA testing, full blood count and repetition of indeterminate assays, being stored for future research.
All tests will be conducted using standardised protocols.(6) ACTION AFTER TESTING: This will follow existing NICE guidance. (1;2) A) If negative by TST and IGRA, follow up only. B) If positive by either TST or IGRA tests, active TB will be excluded. Those without active TB will be followed up. C) If positive by IGRA \& TST test and > 35 yrs, follow up only and for those 16-34 yrs, chemoprophylaxis will be offered with balanced advice about potential benefits/risks.
PRIMARY OUTCOME: Development of active TB. Prognostic values of tests quantified as incidence rate ratios (RR) among contacts and new entrants. SECONDARY OUTCOME: Side effects from chemoprophylaxis.
FOLLOW UP: average of 24 months from the date of IGRA/TST testing. a) phone call to GP and or patients at 24 months. b) national enhanced TB surveillance. c) national database of culture proven TB. d) Clinic records. ADDITIONAL DATA:
collected on all potential source cases and contacts using a questionnaire and medical records review (see below). HIV status will be determined at the end of the follow-up period through anonymised record linkage with the national HIV surveillance system, which is reliable.(4) DNA finger printing data, from the national strain typing database, will be utilised to ascertain transmission between index cases and subsequent diagnoses among contacts.
ANALYSIS PLAN: The predictive performance of each test (TST, ELISpot and ELISA) will be summarised as the RR of test positives in those developing active TB compared to not (analogous to positive likelihood ratio: TPR/FPR). GEE Poisson regression will compare disease RRs between tests accounting for length of follow-up and exploiting within patient comparisons of tests. Absolute risk of disease in different groups will be described in those with no evidence of LTBI and those with LTBI who have / have not received chemoprophylaxis. Other analyses: HIV infected and risk factors for LTBI.
SAMPLE SIZE: Assuming a LTBI rate of 30%, 5% progressing to active TB in 2 years if untreated and 20% loss to follow-up, simulations indicate a cohort of 5,000 would have 80% power of detecting clinically important differences in predictive performance (P\<0.05) that would arise from differences in sensitivity and specificity of 10% between tests for detecting LTBI. 50% of TB contacts and new entrants are aged >35yrs, so a cohort of 10,000 identifies 5,000 for the primary analysis of progression without treatment. Testing and follow-up of 10,000 would allow appropriately powered secondary analyses a) comparing contacts and immigrants, b) estimating progression on treatment using regression models to adjust for test dependent treatment decisions.
ECONOMIC ANALYSIS: The cost-effectiveness of alternative screening strategies for patients with suspected LTBI will be assessed. A decision model will be developed to estimate the costs (£) and health effects (QALYs) of the following strategies: a) no screening, b) TST alone, c) different IGRA tests (ELISA or ELISpot), and d) TST followed by IGRA if positive. These strategies will be compared for: contacts and new entrants stratified by age and baseline risk. The model will use data from the cohort study and the published literature, and will follow the NICE reference case (5). Probabilistic sensitivity analysis will be used to assess uncertainty. Benefits due to prevention of transmission will be estimated.
199 studies on the registry are indexed under Latent Tuberculosis; 48 are open to participants now.
This study's enrollment of 10,000 is above the median of 260 across 82 observational studies indexed under Latent Tuberculosis.
Browse Latent Tuberculosis studies →Public Health England is the lead sponsor of 37 studies on the registry; none are open to participants now.
Compared within Latent Tuberculosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tuberculosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Those who are close contacts of active tuberculosis cases or those who have are new entrants to the UK from high incidence countries (>40/100000).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contacts of active cases of tuberculosis
new entrants from high incidence (\>40/100000) countries.
Development of active TB. Prognostic values of tests quantified as incidence rate ratios (RR) among contacts and new entrants
Time frame: two years
Side effects from chemoprophylaxis
Time frame: two years
Plan to share: No
The record gives a start of Aug 2010, a primary completion of Jun 2015 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Public Health England