TuberculosisNCT00780546
Spatial Epidemiology of Tuberculosis (TB) Infection
An observational study of Tuberculosis, run by National Taiwan University Hospital at 1 site in Taiwan.
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
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.
- First posted27 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2009 (estimated)
- Study completionJul 2009 (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 National Taiwan University HospitalThe 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chi-Tai Fang, PhD, Study director, National Taiwan UniversityTzai-Hung Wen, PhD, Study director, National Taiwan UniversityIn Chan Ng, bachelor, Principal investigator, National Taiwan University
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Epidemiology of Tuberculosis Infection
- ClinicalTrials.gov ID
- NCT00780546
- Acronym / sponsor ID
- 200808047R
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, spatial epidemiology, geographic information system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- May 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 27 Oct 2008 (estimated)
- 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.
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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- NTUH patients
Key inclusion criteria (1 listed)
- TB patients of NTUH
Key exclusion criteria (1 listed)
- TB patient whose address cannot be geocoded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2008.
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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.
In Chan Ng, Bachelor contact
Chi-Tai Fang, PhD study director
National Taiwan University
Tzai-Hung Wen, PhD study director
National Taiwan University
In Chan Ng, bachelor principal investigator
National Taiwan University
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, 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.