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23andMe IPF Research Study (IPF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05028894
Recruitment Status : Active, not recruiting
First Posted : August 31, 2021
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
23andMe, Inc.

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Other: No intervention

Detailed 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.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 690 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: 23andMe Idiopathic Pulmonary Fibrosis Research Study
Actual Study Start Date : June 5, 2020
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
IPF
Participants diagnosed with idiopathic pulmonary fibrosis
 Other: No intervention
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. IPF Symptom Progression Baseline [ Time Frame: Baseline ]
    Survey asking about disease diagnosis, testing, treatments, and symptom progression

  2. IPF Symptom Progression 3 month follow-up [ Time Frame: 3 months post baseline ]
    IPF Symptom Progression 3 month follow-up

  3. IPF Symptom Progression 6 month follow-up [ Time Frame: 6 months post baseline ]
    Survey asking about disease diagnosis, testing, treatments, and symptom progression

  4. IPF Symptom Progression 9 month follow-up [ Time Frame: 9 months post baseline ]
    Survey asking about disease diagnosis, testing, treatments, and symptom progression


Biospecimen Retention:   Samples With DNA
Saliva sample

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will only include participants who meet the eligibility criteria as described above. Participants in the study will be diagnosed with IPF or HPS.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05028894


Locations
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United States, California
23andMe
Sunnyvale, California, United States, 94086
Sponsors and Collaborators
23andMe, Inc.
Investigators
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Principal Investigator: Suyash Shringarpure 23andMe, Inc.
More Information
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Responsible Party: 23andMe, Inc.
ClinicalTrials.gov Identifier: NCT05028894    
Other Study ID Numbers: 23andMe_IPF001
First Posted: August 31, 2021    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 23andMe, Inc.:
idiopathic pulmonary fibrosis
IPF
pulmonary fibrosis
lung diseases
lung
 respiratory tract diseases
rare
rare diseases
Hermansky-Pudlak syndrome
HPS
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases