Idiopathic Pulmonary FibrosisPROFILENCT01134822
Prospective Study of Fibrosis In the Lung Endpoints (PROFILE - Central England)
An observational study of Idiopathic Pulmonary Fibrosis, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The overall aim of this study is to develop a test that predicts the prognosis of IPF (Idiopathic Pulmonary Fibrosis) and which could be used to determine whether new treatments for IPF are likely to work. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 330 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to 5 Sep 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from IPF clinics
Who may be able to join
- A diagnosis of IPF using the consensus criteria (32)and Non Specific Interstitial Pneumonia.
- Between the age group 18-85 years.
- Sub classified into Mild (TLCO>60), Moderate (TLCO 40-60), Severe (TLCO<40).
- People who volunteer to undergo a bronchoscopy for research
Who cannot join
- People who do not have IPF/NSIP (i.e. Hypersensitivity Pneumonitis, Sarcoidosis)
- People who cannot give informed consent.
- People who are being considered for bronchoscopy, any contra-indication to undergoing this procedure as set out in the British Thoracic Society guidelines (Thorax 2001; 56: suppl I: i1-i21). These will be part of the study but not undergo the Broncho Alveolar Lavage.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
About this study
The overall aim of this study is to develop a test that predicts the prognosis of IPF (Idiopathic Pulmonary Fibrosis) and which could be used to determine whether new treatments for IPF are likely to work.
Read the detailed description
The overall objectives of this study are
- Discover and validate novel biomarkers and gene expression profiles for use in subsequent intervention studies in patients with IPF
- To prospectively validate a panel of previously published biomarkers in patients with well characterized idiopathic fibrosing lung disease
- Investigate genetic associations and epigenetic modifications which affect disease severity and progression
- Prospectively evaluate longitudinal disease behaviour in patients with IPF and NSIP with a view to developing composite clinical end-points for subsequent use in intervention studies in patients with IPF
Biomarkers that can be used for the following purposes will be identified:
- Identify patients (Diagnostic)(e.g. discriminate between health and disease)
- Correlate with disease severity (extent of disease, staging of disease)
- Predict clinical progression (Prognostic)(stable vs progressive disease)
- Track response to therapy (Therapeutic response)- Predict response to known efficacious treatments \& Correlates with changes in clinical endpoints/mortality/quality of life
- Predict risk of exacerbations (could be used to prevent exacerbations or reduce their severity)
- Correlate with complications and/or comorbidities (e.g. biomarkers of Pulmonary Arterial Hypertension, Gastro Oesophageal Reflux in IPF, etc)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, Lung Fibrosis, Biomarkers
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic pulmonary fibrosis (IPF) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discover biomarkers in IPF
- Discover and validate novel biomarkers for use in subsequent intervention studies in patients with IPF
- To prospectively validate a panel of previously published biomarkers in patients with well characterized idiopathic fibrosing lung disease
- Investigate genetic associations and epigenetic modifications which affect disease severity and progression
Measured: 36 months
Secondary outcomes (1)
Survival from Pulmonary fibrosis.
All patients will be tagged at the central NHS registry in order to provide mortality data. For this reason we will need to keep our datasets active for up to 10 years to allow a complete mortality analysis.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJul 2010
- Primary completion5 Sep 2017
- Study completion5 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, GlaxoSmithKline, CRAFT Consortium, McMaster University
- Responsible party
- Sponsor
- Investigators
- Gisli Jenkins, Dr, Study director, University of NottinghamRobert Berg, Dr, Principal investigator, University Hospitals of Derby and Burton NHS Foundation TrustSanjay Agarwal, Dr, Principal investigator, University Hospitals, LeicesterMoira White, Dr, Principal investigator, Sheffield Teaching Hospitals NHS Foundation TrustKhaled Amsha, Dr, Principal investigator, Sherwood Forest Hospitals NHS TrustDavid Thickett, Dr, Principal investigator, University Hospital Birmingham NHS Foundation TrustUttam Nanda, Dr, Principal investigator, Burton Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134822
- Sponsor's protocol ID
- 09116
- Acronym
- PROFILE
- Status last verified
- Jan 2017
- First submitted
- 28 May 2010
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.
PubMed 35688625Clynick B, Corte TJ, Jo HE, Stewart I, Glaspole IN, Grainge C, Maher TM, Navaratnam V, Hubbard R, Hopkins PMA, Reynolds PN, Chapman S, Zappala C, Keir GJ, Cooper WA, Mahar AM, Ellis S, Goh NS, De Jong E, Cha L, Tan DBA, Leigh L, Oldmeadow C, Walters EH, Jenkins RG, Moodley Y. Biomarker signatures for progressive idiopathic pulmonary fibrosis. Eur Respir J. 2022 Mar 31;59(3):2101181. doi: 10.1183/13993003.01181-2021. Print 2022 Mar.
PubMed 34675050Maher TM, Oballa E, Simpson JK, Porte J, Habgood A, Fahy WA, Flynn A, Molyneaux PL, Braybrooke R, Divyateja H, Parfrey H, Rassl D, Russell AM, Saini G, Renzoni EA, Duggan AM, Hubbard R, Wells AU, Lukey PT, Marshall RP, Jenkins RG. An epithelial biomarker signature for idiopathic pulmonary fibrosis: an analysis from the multicentre PROFILE cohort study. Lancet Respir Med. 2017 Dec;5(12):946-955. doi: 10.1016/S2213-2600(17)30430-7. Epub 2017 Nov 14.
PubMed 29150411Jenkins RG, Simpson JK, Saini G, Bentley JH, Russell AM, Braybrooke R, Molyneaux PL, McKeever TM, Wells AU, Flynn A, Hubbard RB, Leeming DJ, Marshall RP, Karsdal MA, Lukey PT, Maher TM. Longitudinal change in collagen degradation biomarkers in idiopathic pulmonary fibrosis: an analysis from the prospective, multicentre PROFILE study. Lancet Respir Med. 2015 Jun;3(6):462-72. doi: 10.1016/S2213-2600(15)00048-X. Epub 2015 Mar 12.
PubMed 25770676
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Fibrosis In the Lung Endpoints (PROFILE - Central England)
- ClinicalTrials.gov ID
- NCT01134822
- Acronym / sponsor ID
- PROFILE / 09116
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, Lung Fibrosis, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Medical Research Council, GlaxoSmithKline, CRAFT Consortium, McMaster University
- Study start
- Jul 2010
- Primary completion
- 5 Sep 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 2 Jun 2010 (estimated)
- 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 overall aim of this study is to develop a test that predicts the prognosis of IPF (Idiopathic Pulmonary Fibrosis) and which could be used to determine whether new treatments for IPF are likely to work.
Detailed description
The overall objectives of this study are
- Discover and validate novel biomarkers and gene expression profiles for use in subsequent intervention studies in patients with IPF
- To prospectively validate a panel of previously published biomarkers in patients with well characterized idiopathic fibrosing lung disease
- Investigate genetic associations and epigenetic modifications which affect disease severity and progression
- Prospectively evaluate longitudinal disease behaviour in patients with IPF and NSIP with a view to developing composite clinical end-points for subsequent use in intervention studies in patients with IPF
Biomarkers that can be used for the following purposes will be identified:
- Identify patients (Diagnostic)(e.g. discriminate between health and disease)
- Correlate with disease severity (extent of disease, staging of disease)
- Predict clinical progression (Prognostic)(stable vs progressive disease)
- Track response to therapy (Therapeutic response)- Predict response to known efficacious treatments \& Correlates with changes in clinical endpoints/mortality/quality of life
- Predict risk of exacerbations (could be used to prevent exacerbations or reduce their severity)
- Correlate with complications and/or comorbidities (e.g. biomarkers of Pulmonary Arterial Hypertension, Gastro Oesophageal Reflux in IPF, etc)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic pulmonary fibrosis (IPF) | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from IPF clinics
Key inclusion criteria (4 listed)
- A diagnosis of IPF using the consensus criteria (32)and Non Specific Interstitial Pneumonia.
- Between the age group 18-85 years.
- Sub classified into Mild (TLCO>60), Moderate (TLCO 40-60), Severe (TLCO<40).
- People who volunteer to undergo a bronchoscopy for research
Key exclusion criteria (3 listed)
- People who do not have IPF/NSIP (i.e. Hypersensitivity Pneumonitis, Sarcoidosis)
- People who cannot give informed consent.
- People who are being considered for bronchoscopy, any contra-indication to undergoing this procedure as set out in the British Thoracic Society guidelines (Thorax 2001; 56: suppl I: i1-i21). These will be part of the study but not undergo the Broncho Alveolar Lavage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Discover biomarkers in IPF
Time frame: 36 months
* Discover and validate novel biomarkers for use in subsequent intervention studies in patients with IPF * To prospectively validate a panel of previously published biomarkers in patients with well characterized idiopathic fibrosing lung disease * Investigate genetic associations and epigenetic modifications which affect disease severity and progression
1 secondary outcome
Survival from Pulmonary fibrosis.
Time frame: 10 years
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 15 Oct 2018.
- Derived from this study: PubMed 35688625Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.
- Derived from this study: PubMed 34675050Clynick B, Corte TJ, Jo HE, Stewart I, Glaspole IN, Grainge C, Maher TM, Navaratnam V, Hubbard R, Hopkins PMA, Reynolds PN, Chapman S, Zappala C, Keir GJ, Cooper WA, Mahar AM, Ellis S, Goh NS, De Jong E, Cha L, Tan DBA, Leigh L, Oldmeadow C, Walters EH, Jenkins RG, Moodley Y. Biomarker signatures for progressive idiopathic pulmonary fibrosis. Eur Respir J. 2022 Mar 31;59(3):2101181. doi: 10.1183/13993003.01181-2021. Print 2022 Mar.
- Derived from this study: PubMed 29150411Maher TM, Oballa E, Simpson JK, Porte J, Habgood A, Fahy WA, Flynn A, Molyneaux PL, Braybrooke R, Divyateja H, Parfrey H, Rassl D, Russell AM, Saini G, Renzoni EA, Duggan AM, Hubbard R, Wells AU, Lukey PT, Marshall RP, Jenkins RG. An epithelial biomarker signature for idiopathic pulmonary fibrosis: an analysis from the multicentre PROFILE cohort study. Lancet Respir Med. 2017 Dec;5(12):946-955. doi: 10.1016/S2213-2600(17)30430-7. Epub 2017 Nov 14.
- Derived from this study: PubMed 25770676Jenkins RG, Simpson JK, Saini G, Bentley JH, Russell AM, Braybrooke R, Molyneaux PL, McKeever TM, Wells AU, Flynn A, Hubbard RB, Leeming DJ, Marshall RP, Karsdal MA, Lukey PT, Maher TM. Longitudinal change in collagen degradation biomarkers in idiopathic pulmonary fibrosis: an analysis from the prospective, multicentre PROFILE study. Lancet Respir Med. 2015 Jun;3(6):462-72. doi: 10.1016/S2213-2600(15)00048-X. Epub 2015 Mar 12.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
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.
Gisli Jenkins, Dr study director
University of Nottingham
Robert Berg, Dr principal investigator
University Hospitals of Derby and Burton NHS Foundation Trust
Sanjay Agarwal, Dr principal investigator
University Hospitals, Leicester
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 University of Nottingham at 1 site in United Kingdom.
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 4 inclusion and 3 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 15 Oct 2018. 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 Kingdom. 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?
Discover biomarkers in IPF (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01134822, which also lists 4 linked publications.
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 15 Oct 2018.