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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05028894
Other study ID # 23andMe_IPF001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 5, 2020
Est. completion date December 1, 2023

Study information

Verified date November 2022
Source 23andMe, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The long term goal of this study is to increase genetic understanding of IPF to enable the development of an effective drug for IPF that can improve the lives of those living with the condition.


Description:

This study will recruit 1,000 people who have been diagnosed with IPF or Hermansky-Pudlak syndrome (HPS). Eligible participants who consent to participate in 23andMe Research and the IPF Research Study will receive a 23andMe Health + Ancestry kit at no cost. Participants will provide a saliva sample and take a baseline survey online answering questions about their disease diagnosis, testing, treatment, and symptoms. Participants will also be asked to take the same survey 3, 6, and 9 months after completing the baseline survey. The data collected from this study will be incorporated into the 23andMe Database and used to better understand the underlying genetic and environmental factors that contribute to IPF.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 690
Est. completion date December 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have been diagnosed with IPF or Hermansky-Pudlak syndrome (HPS) - Are 18+ years old - Live in the US Exclusion Criteria: - Have been diagnosed with sarcoidosis or hypersensitivity pneumonitis

Study Design


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
United States 23andMe Sunnyvale California

Sponsors (1)

Lead Sponsor Collaborator
23andMe, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary IPF Symptom Progression Baseline Survey asking about disease diagnosis, testing, treatments, and symptom progression Baseline
Primary IPF Symptom Progression 3 month follow-up IPF Symptom Progression 3 month follow-up 3 months post baseline
Primary IPF Symptom Progression 6 month follow-up Survey asking about disease diagnosis, testing, treatments, and symptom progression 6 months post baseline
Primary IPF Symptom Progression 9 month follow-up Survey asking about disease diagnosis, testing, treatments, and symptom progression 9 months post baseline
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