23andMe IPF Research Study (IPF)

• ClinicalTrials.gov Identifier: NCT05028894
• Recruitment Status: Active, not recruiting
• First Posted: August 31, 2021
• Last Update Posted: November 3, 2022
• Sponsor: 23andMe, Inc.
• Information provided by (Responsible Party): 23andMe, Inc.

Tracking Information

• First Submitted Date: August 26, 2021
• First Posted Date: August 31, 2021
• Last Update Posted Date: November 3, 2022
• Actual Study Start Date: June 5, 2020
• Estimated Primary Completion Date: November 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 26, 2021)

• IPF Symptom Progression Baseline [ Time Frame: Baseline ]
  Survey asking about disease diagnosis, testing, treatments, and symptom progression
• IPF Symptom Progression 3 month follow-up [ Time Frame: 3 months post baseline ]
  IPF Symptom Progression 3 month follow-up
• IPF Symptom Progression 6 month follow-up [ Time Frame: 6 months post baseline ]
  Survey asking about disease diagnosis, testing, treatments, and symptom progression
• IPF Symptom Progression 9 month follow-up [ Time Frame: 9 months post baseline ]
  Survey asking about disease diagnosis, testing, treatments, and symptom progression

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 23andMe IPF Research Study
• Official Title: 23andMe Idiopathic Pulmonary Fibrosis Research Study
• 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.
• 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 Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 9 Months

Biospecimen

Retention:   Samples With DNA

Description:

Saliva sample

• 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.
• Condition: Idiopathic Pulmonary Fibrosis

Intervention

Other: No intervention

No intervention

Study Groups/Cohorts

IPF

Participants diagnosed with idiopathic pulmonary fibrosis

Intervention: Other: No intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 1, 2022): 690
• Original Estimated Enrollment (submitted: August 26, 2021): 1000
• Estimated Study Completion Date: December 1, 2023
• Estimated Primary Completion Date: November 1, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05028894
• Other Study ID Numbers: 23andMe_IPF001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: 23andMe, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: 23andMe, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: 23andMe, Inc.
• Verification Date: November 2022