History of Changes for Study: NCT05028894

23andMe IPF Research Study (IPF)

Latest version (submitted November 1, 2022) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	August 26, 2021	None (earliest Version on record)
2	September 9, 2021	Study Status and References
3	November 1, 2022	Recruitment Status, Study Status, Contacts/Locations, Study Design and References

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Study NCT05028894
Submitted Date: September 9, 2021 (v2)

Study Identification


Unique Protocol ID:	23andMe_IPF001
Brief Title:	23andMe IPF Research Study (IPF)
Official Title:	23andMe Idiopathic Pulmonary Fibrosis Research Study
Secondary IDs:

Study Status


Record Verification:	September 2021
Overall Status:	Recruiting
Study Start:	June 5, 2020
Primary Completion:	November 1, 2021 [Anticipated]
Study Completion:	August 1, 2022 [Anticipated]

First Submitted:	August 26, 2021
First Submitted that Met QC Criteria:	August 26, 2021
First Posted:	August 31, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	September 9, 2021
Last Update Posted:	September 16, 2021 [Actual]

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.

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.

Conditions


Conditions:	Idiopathic Pulmonary Fibrosis
Keywords:	idiopathic pulmonary fibrosis IPF pulmonary fibrosis lung diseases lung respiratory tract diseases rare rare diseases Hermansky-Pudlak syndrome HPS

Study Design


Study Type:	Observational [Patient Registry]
Observational Study Model:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:	Samples With DNA
Biospecimen Description:	Saliva sample
Enrollment:	1000 [Anticipated]
Number of Groups/Cohorts	1
Target Follow-Up Duration:	9 Months

Outcome Measures


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

Eligibility


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.
Sampling Method:	Non-Probability Sample
Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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/Locations


Central Contact Person:	Suyash Shringarpure Telephone: 1-650-933-9472 Email: ipf-study@23andme.com
Study Officials:	Suyash Shringarpure Principal Investigator 23andMe, Inc.
Locations:	United States, California
	23andMe [Recruiting] Sunnyvale, California, United States, 94086 Contact:Contact: Suyash Shringarpure

References


Citations:
Links:	URL: https://www.23andme.com/idiopathic-pulmonary-fibrosis/?utm_source=clinicaltrials Description: Idiopathic Pulmonary Fibrosis Research Study landing page
Available IPD/Information:

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