Lung DiseasesNCT00005290
Epidemiology of Interstitial Lung Disease
An observational study of Lung Diseases and Lung Diseases, Interstitial, run by University of New Mexico.
Trial summary
To establish a population-based registry of interstitial lung disease in Bernalillo County, New Mexico. Read more about this study
- Who is it for?
- Ages 0 to 100 years, men only
- Conditions the study is for
- Lung Diseases, Lung Diseases, Interstitial
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1988to Jun 1997
- 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 0 to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To establish a population-based registry of interstitial lung disease in Bernalillo County, New Mexico.
Read the detailed description
BACKGROUND:
Although many investigations have been conducted to characterize the pathogenesis of interstitial lung diseases, few examined the epidemiology of these disorders in a general population. The establishment of the registry represented the first step in a sequence of investigations designed to characterize the epidemiology of the interstitial lung diseases. The registry initially served a descriptive purpose; the incidence of the interstitial lung diseases was measured in a defined population. Subsequently the registry served as a mechanism for ascertaining cases for a case-control study. Finally, the registry provided population-based data for clinical purposes on presentation, physiology, and natural history of the interstitial lung diseases.
DESIGN NARRATIVE:
The resources of the New Mexico Tumor Registry were adapted to identify new cases of interstitial lung disease in Bernalillo County. Other sources of information for identifying new cases included pulmonary physicians, primary care physicians, death certificates, and autopsies. After a case of interstitial lung disease had been identified from the various sources of information, data collection included an interviewer-administered symptoms questionnaire, abstracted medical record data, phlebotomy for measurement of serum precipitins, and evaluation of available chest x-rays and biopsy materials. Follow-up was used to determine the natural history of the disease.
The study was renewed in 1993 to complete the work conducted from 1988 through 1992. Case-ascertainment, data collection, and follow-up of incident cases of ILD identified during the period 10/1/88-9/30/92 were completed. The incidence of ILDs was described. The clinical characteristics of patients with ILDs were described. The prognosis of the most common ILDs were described.
- Conditions
- Lung Diseases, Lung Diseases, Interstitial
- Medical subject headings
- Lung Diseases, Lung Diseases, Interstitial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startApr 1988
- Study completionJun 1997
Why it stopped: Not a clinical trial \& was inadvertently entered into the system.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005290
- Sponsor's protocol ID
- 2012
- Other IDs
- R01HL040587
- Status last verified
- Mar 2024
- First submitted
- 25 May 2000
- Last updated
- 12 Mar 2024
- Results posted
- No
Publications
Mapel DW, Samet JM, Coultas DB. Corticosteroids and the treatment of idiopathic pulmonary fibrosis. Past, present, and future. Chest. 1996 Oct;110(4):1058-67. doi: 10.1378/chest.110.4.1058. No abstract available.
PubMed 8874268Coultas DB, Hughes MP. Accuracy of mortality data for interstitial lung diseases in New Mexico, USA. Thorax. 1996 Jul;51(7):717-20. doi: 10.1136/thx.51.7.717.
PubMed 8882079Coultas DB, Zumwalt RE, Black WC, Sobonya RE. The epidemiology of interstitial lung diseases. Am J Respir Crit Care Med. 1994 Oct;150(4):967-72. doi: 10.1164/ajrccm.150.4.7921471.
PubMed 7921471Mulloy KB, Coultas DB, Samet JM. Use of chest radiographs in epidemiological investigations of pneumoconioses. Br J Ind Med. 1993 Mar;50(3):273-5. doi: 10.1136/oem.50.3.273.
PubMed 8457495Mapel DW, Hunt WC, Utton R, Baumgartner KB, Samet JM, Coultas DB. Idiopathic pulmonary fibrosis: survival in population based and hospital based cohorts. Thorax. 1998 Jun;53(6):469-76. doi: 10.1136/thx.53.6.469.
PubMed 9713446
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT00005290
- Acronym / sponsor ID
- 2012
- Conditions
- Lung Diseases, Lung Diseases, Interstitial
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not a clinical trial \& was inadvertently entered into the system.
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 1988
- Study completion
- Jun 1997
- First posted
- 26 May 2000 (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.
To establish a population-based registry of interstitial lung disease in Bernalillo County, New Mexico.
Detailed description
BACKGROUND:
Although many investigations have been conducted to characterize the pathogenesis of interstitial lung diseases, few examined the epidemiology of these disorders in a general population. The establishment of the registry represented the first step in a sequence of investigations designed to characterize the epidemiology of the interstitial lung diseases. The registry initially served a descriptive purpose; the incidence of the interstitial lung diseases was measured in a defined population. Subsequently the registry served as a mechanism for ascertaining cases for a case-control study. Finally, the registry provided population-based data for clinical purposes on presentation, physiology, and natural history of the interstitial lung diseases.
DESIGN NARRATIVE:
The resources of the New Mexico Tumor Registry were adapted to identify new cases of interstitial lung disease in Bernalillo County. Other sources of information for identifying new cases included pulmonary physicians, primary care physicians, death certificates, and autopsies. After a case of interstitial lung disease had been identified from the various sources of information, data collection included an interviewer-administered symptoms questionnaire, abstracted medical record data, phlebotomy for measurement of serum precipitins, and evaluation of available chest x-rays and biopsy materials. Follow-up was used to determine the natural history of the disease.
The study was renewed in 1993 to complete the work conducted from 1988 through 1992. Case-ascertainment, data collection, and follow-up of incident cases of ILD identified during the period 10/1/88-9/30/92 were completed. The incidence of ILDs was described. The clinical characteristics of patients with ILDs were described. The prognosis of the most common ILDs were described.
Study design
Who may qualify
- Ages
- 0 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
The study was stopped early (reason given: Not a clinical trial \& was inadvertently entered into the system.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 8874268Mapel DW, Samet JM, Coultas DB. Corticosteroids and the treatment of idiopathic pulmonary fibrosis. Past, present, and future. Chest. 1996 Oct;110(4):1058-67. doi: 10.1378/chest.110.4.1058. No abstract available.
- Background: PubMed 8882079Coultas DB, Hughes MP. Accuracy of mortality data for interstitial lung diseases in New Mexico, USA. Thorax. 1996 Jul;51(7):717-20. doi: 10.1136/thx.51.7.717.
- Background: PubMed 7921471Coultas DB, Zumwalt RE, Black WC, Sobonya RE. The epidemiology of interstitial lung diseases. Am J Respir Crit Care Med. 1994 Oct;150(4):967-72. doi: 10.1164/ajrccm.150.4.7921471.
- Background: PubMed 8457495Mulloy KB, Coultas DB, Samet JM. Use of chest radiographs in epidemiological investigations of pneumoconioses. Br J Ind Med. 1993 Mar;50(3):273-5. doi: 10.1136/oem.50.3.273.
- Background: PubMed 9713446Mapel DW, Hunt WC, Utton R, Baumgartner KB, Samet JM, Coultas DB. Idiopathic pulmonary fibrosis: survival in population based and hospital based cohorts. Thorax. 1998 Jun;53(6):469-76. doi: 10.1136/thx.53.6.469.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Lung Diseases, Interstitial, run by University of New Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: Not a clinical trial \& was inadvertently entered into the system.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005290, which also lists 5 linked publications.
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 12 Mar 2024.