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TuberculosisNCT00780546

Spatial Epidemiology of Tuberculosis (TB) Infection

An observational study of Tuberculosis, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Data will be extracted from the NTUH medical records database, geocoded according to the street address so that the case number, incidence, etc could be mapped. The spatial data would be used to detect aggregation of TB cases, existence of "hot spots" and then determine if they may merit further investigation or may… Read more about this study

Who is it for?
Any age
Conditions the study is for
Tuberculosis
How many people
1,000 participants
Where
1 siteTaiwan
Study dates
Oct 2008to Jul 2009
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
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: NTUH patients

Who may be able to join

  • TB patients of NTUH

Who cannot join

  • TB patient whose address cannot be geocoded

Trial locations and contacts

1 site in 1 country.

In Chan Ng, Bachelor contact

r96842013@ntu.edu.tw

Taiwan1 site
  • National Taiwan University Hospital

    Taipei, Taipei, 100

Other trials in Taiwan

About this study

Official title: Spatial Epidemiology of Tuberculosis Infection

Data will be extracted from the NTUH medical records database, geocoded according to the street address so that the case number, incidence, etc could be mapped. The spatial data would be used to detect aggregation of TB cases, existence of "hot spots" and then determine if they may merit further investigation or may have occurred by chance. The results from these GIS-based analyses would address local variations in TB incidence and transmission.

Read the detailed description

This is a Geographic Information System (GIS)-based retrospective study. Data will be extracted from the NTUH medical records database, including the date of notification, sex, birth date, residence address, etc of each tuberculosis case. Each case will be geocoded to generate spatial coordinates for mapping purpose based on the street address and postal code. To protect the privacy of these patients, the personal identification data of TB patients, including name and ID numbers, will not be encoded. The encoded data file will also be strictly kept confidential.

Disease mapping is the usual means of presenting descriptive geographic data on disease occurrence and creating accurate maps of disease morbidity and mortality. Maps convey instant visual information on the spatial distribution of disease and can identify subtle patterns which may be missed in tabular presentations. The purpose is to display variations in ill-health (for example, related to the underlying sociodemography), formulate etiologic hypotheses, aid surveillance to detect areas of high disease incidence, and help place specific disease.

In detecting the spatial patterns of the points geocoded from the addresses, point pattern analytical methods are used. Quadrat Analysis is one of them. This method evaluates a case distribution by examining how its density changes over space. The density measured by Quadrat Analysis is then compared with the density of a theoretically constructed random pattern to see if the case distribution in question is more clustered or more dispersed than the random pattern. Another one is Nearest Neighbor Statistic, which is derived from the average distance between cases and each of their nearest neighbors and captures information on cases between quadrats. Using ordered neighbor statistic can evaluate the pattern at different spatial scales. A case pattern is said to be more clustered if its observed average distance between nearest neighbors is found to be less than that of a random pattern. Ripley's K statistic is an extension of the ordered neighbor statistics, which can be used to depict the randomness of a case distribution over different spatial scales and capture the characteristic of local variations.

To measure and test how dispersed/clustered the case locations are with respect to their attribute values, e.g. socioeconomic status, spatial autocorrelation can be performed. If significant positive spatial autocorrelation exists in a case distribution, cases with similar characteristics tend to be near each other.

For polygon data in interval or ratio form, such as the tuberculosis incidence of different districts, Moran's I index, Geary's Ratio and the G-statistic can be used. Moran's I uses the mean of the attribute's data values as the benchmark for comparison when neighboring values are evaluated; Geary's Ratio is based on a direct comparison of neighboring values; G-statistic is based on the concept of spatial association or cross-product statistics and is capable of detecting the presence of hot spots or cold spots. In case of spatial heterogeneity, i.e. the magnitude of spatial autocorrelation varies over space, modified versions of the previous three statistics can be used to evaluate spatial association at the local scale.

Conditions
Tuberculosis
Keywords
tuberculosis, spatial epidemiology, geographic information system
Medical subject headings
Tuberculosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionMay 2009 (estimated)
  4. Study completionJul 2009 (estimated)

Resources

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
Ecologic or community
Time perspective
Retrospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00780546
Sponsor's protocol ID
200808047R
Status last verified
Oct 2008
First submitted
24 Oct 2008
Last updated
27 Oct 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Tuberculosis, run by National Taiwan University Hospital at 1 site in Taiwan.

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 27 Oct 2008. 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 Taiwan. 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 In Chan Ng, Bachelor (r96842013@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

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 27 Oct 2008.

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