Idiopathic Pulmonary FibrosisIPFNCT05028894
23andMe IPF Research Study
An observational study of Idiopathic Pulmonary Fibrosis, run by 23andMe, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 690 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2020to 5 May 2023
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Have been diagnosed with IPF or Hermansky-Pudlak syndrome (HPS)
- Are 18+ years old
- Live in the US
Who cannot join
- Have been diagnosed with sarcoidosis or hypersensitivity pneumonitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 23andMe Idiopathic Pulmonary Fibrosis Research Study
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.
Read the 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
- Idiopathic Pulmonary Fibrosis
- Being tested
- No intervention
- Keywords
- idiopathic pulmonary fibrosis, IPF, pulmonary fibrosis, lung diseases, lung, respiratory tract diseases, rare, rare diseases, Hermansky-Pudlak syndrome, HPS
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Lung Diseases, Respiratory Tract Diseases, Rare Diseases, Hermanski-Pudlak Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| IPF | Participants diagnosed with idiopathic pulmonary fibrosis Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPF Symptom Progression Baseline
Survey asking about disease diagnosis, testing, treatments, and symptom progression
Measured: Baseline
IPF Symptom Progression 3 month follow-up
IPF Symptom Progression 3 month follow-up
Measured: 3 months post baseline
IPF Symptom Progression 6 month follow-up
Survey asking about disease diagnosis, testing, treatments, and symptom progression
Measured: 6 months post baseline
IPF Symptom Progression 9 month follow-up
Survey asking about disease diagnosis, testing, treatments, and symptom progression
Measured: 9 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start5 Jun 2020
- Primary completion5 May 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 690 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- 23andMe, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suyash Shringarpure, Principal investigator, 23andMe, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028894
- Sponsor's protocol ID
- 23andMe_IPF001
- Acronym
- IPF
- Status last verified
- Dec 2024
- First submitted
- 26 Aug 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 23andMe Idiopathic Pulmonary Fibrosis Research Study
- ClinicalTrials.gov ID
- NCT05028894
- Acronym / sponsor ID
- IPF / 23andMe_IPF001
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- idiopathic pulmonary fibrosis, IPF, pulmonary fibrosis, lung diseases, lung, respiratory tract diseases, rare, rare diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- 23andMe, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPF | – | Other: No interventionParticipants diagnosed with idiopathic pulmonary fibrosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Have been diagnosed with IPF or Hermansky-Pudlak syndrome (HPS)
- Are 18+ years old
- Live in the US
Key exclusion criteria (1 listed)
- Have been diagnosed with sarcoidosis or hypersensitivity pneumonitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | IPF |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suyash Shringarpure principal investigator
23andMe, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by 23andMe, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPF Symptom Progression Baseline (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.