23andMe IPF Research Study

Sponsor
23andMe, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05028894
Collaborator
(none)
1,000
1
25.9
38.7

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
23andMe Idiopathic Pulmonary Fibrosis Research Study
Actual Study Start Date :
Jun 5, 2020
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
IPF

Participants diagnosed with idiopathic pulmonary fibrosis

Other: No intervention
No intervention

Outcome Measures

Primary Outcome Measures

  1. IPF Symptom Progression Baseline [Baseline]

    Survey asking about disease diagnosis, testing, treatments, and symptom progression

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

    IPF Symptom Progression 3 month follow-up

  3. IPF Symptom Progression 6 month follow-up [6 months post baseline]

    Survey asking about disease diagnosis, testing, treatments, and symptom progression

  4. IPF Symptom Progression 9 month follow-up [9 months post baseline]

    Survey asking about disease diagnosis, testing, treatments, and symptom progression

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 23andMe Sunnyvale California United States 94086

Sponsors and Collaborators

  • 23andMe, Inc.

Investigators

  • Principal Investigator: Suyash Shringarpure, 23andMe, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
23andMe, Inc.
ClinicalTrials.gov Identifier:
NCT05028894
Other Study ID Numbers:
  • 23andMe_IPF001
First Posted:
Aug 31, 2021
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by 23andMe, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2021