A Registry for Nontuberculous Mycobacterial Pulmonary Disease

NCT04078412 | Enrolling By Invitation DMC

• 1 other identifier: 4-2017-0958
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Background: NTM(Nontuberculous mycobacteria) pulmonary disease is increasing worldwidely, however the diagnosis and treatment of NTM pulmonary disease still has multiple obstacles. The initiation of treatment is not necessary for all patients with NTM pulmonary disease. In addition, the drugs for treatment of NTM pulmonary disease is not enough. objective. The aim of this prospective registry for Nontuberculous mycobacterial pulmonary disease is to register the NTM pulmonary patients and analysis of the treatment outcome based on the species and to collect the blood and urine samples from the patients for exploring the biomarker for diagnosis and monitoring the NTM pulmonary disease and collect the nontuberculous mycobacterium. Methods:

1. 1.informed consents
2. 2.register in cohort and collect the clinical information and serum, plasma, urine and mycobacteria
3. 3.follow up 6 months to 1year based on the clinical situation
4. 4.treatment outcome based on NTM-NET consensus statement
5. 5.exploration of biomarker for progression and monitoring of treatment response

Conditions

Nontuberculous Mycobacterial Pulmonary Disease

Keywords

Nontuberculous mycobacteria; pulmonary; cohort

Outcome Measures

Primary Outcomes (1)

• treatment outcome based on NTM-NET consensus statement

  1. For patients who need the treatment for NTM pulmonary disease : treatment outcome based on the NTM -NET consensus : microbiologic results, clinical symptoms and radiologic results 2. For patients who don't need the treatment for NTM pulmonary disease : progression of NTM-PD defined by clinical, microbiotic and radiologic results.

  At the end of the treatment or 12months after treatment

Secondary Outcomes (8)

• biomarker for disease progression: RNA sequence analysis

  at the beginning of the treatment

• biomarker for disease progression: metabolomic analysis

  at the beginning of the treatment

• biomarker for disease progression: RNA sequence analysis

  at the end of the treatment (through study completion, an average of 12 to 15month after treatment)

• biomarker for disease progression: metabolomic analysis

  at the end of the treatment (through study completion, an average of 12 to 15month after treatment)

• biomarker for monitoring of treatment response: RNA sequence analysis

  at the beginning of the treatment

Study Arms (1)

NTM pulmonary disease

Cohort Description: adults NTM pulmonary disease patients diagnose by criteria of American thoracic society guideline

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpaient clinic and hospitalzed patients in tertiary referral hospital

You may qualify if:

• age 20 or more than 20 years
• diagnosed by ATS criteria for NTM pulmonary disease

You may not qualify if:

• \) not specific

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, urine, RNA and DNA

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 6, 2019
• Study Start: November 21, 2017
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)