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Lung CancerPROFILESNCT03888937

bnP for pRediction of Outcome FollowIng Lung rEsection Surgery

An observational study of Lung Cancer, run by University of Glasgow at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Can BNP be used alongside current risk prediction methods to more accurately identify those at risk of breathlessness and poor quality of life following lung resection? Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Lung Cancer
How many people
250 participants
Where
1 siteUnited Kingdom
Study dates
1 Oct 2018to 1 Oct 2020
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 16 years and older
  • All sexes
  • Child, Adult, Older adult

Study population: With informed consent, BNP blood levels will be measured before and after lung resection in 250 patients at 4 hospitals across the UK. We will target 100 patient recruitment at the Golden Jubilee and 50 from the other 3 centres involved which are Aberdeen Royal Infirmary, Edinburgh Royal Infirmary and Belfast Royal Infirmary.

Who may be able to join

  • Provision of informed consent
  • Age >16 years
  • Planned elective lobectomy/pneumonectomy lung resection by VATS or thoracotomy.

Who cannot join

  • Pregnancy
  • On-going participation in any investigational research which could undermine the scientific basis of the study
  • Conditions that increase BNP artificially such as sepsis, cirrhosis, colon cancer and any intracranial pathologies (see definitions below)
  • MRC score > 2 pre-operatively

Trial locations and contacts

1 site in 1 country.

Dr B Lafferty, MBChB contact

0141 951 5000

brian.lafferty@nhs.net

Dr B Shelley, MBChB contact

0141 951 5000

ben.shelley@glasgow.ac.uk

United Kingdom1 site, 1 recruiting
  • Golden Jubilee National Hospital

    Glasgow, g81 4dy

    Brian Lafferty, MBChB, 0141 951 5000, brian.lafferty@nhs.net

    Ben Shelley, MBChB, ben.shelley@glasgow.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Can BNP be used alongside current risk prediction methods to more accurately identify those at risk of breathlessness and poor quality of life following lung resection?

Read the detailed description

Lung cancer is the second most common type of cancer in the UK and the leading cause of cancer related death. Surgery to remove the tumour and the surrounding lung (lung resection) often provides the best chance of cure. Frequently, patients are smokers with related lung or heart problems increasing the risks associated with surgery. Whilst surgery for lung cancer is considered the best chance of 'cure', patients may suffer long term breathlessness, lowering quality of life. This is important; public engagement work we have performed demonstrates repeatedly that second only to "being alive and cancer free" exercise capacity is the main priority of post-operative patients.

Prediction of breathlessness is difficult and not solely caused by lung removal but also from decreased performance of the heart. Although the surgery does not directly involve the heart, it is thought the damage is caused indirectly by the surgery and by removal of part of the lung. Current methods for predicting the risk of breathlessness after surgery are inaccurate. Some patients are refused surgery based on these methods yet may have had successful surgery. Furthermore, no specific treatment exists for patients considered to be at increased risk of breathlessness.

By identifying patients at risk of breathlessness, we believe an opportunity exists to intervene. A small study we completed (a 'pilot study') suggests measuring a hormone called 'BNP' (B type- natriuretic peptide, released by the heart) will improve prediction of post-operative breathlessness.

With informed consent, BNP blood levels will be measured before and after lung resection in 250 patients at 4 hospitals across the UK. We will target 100 patient recruitment at the Golden Jubilee and 50 from the other 3 centres involved. Validated questionnaires will be distributed following surgery measuring breathlessness and quality of life and returned via post at three months and at one year. Questionnaires were selected via patient and public involvement to represent what matters most to patients following surgery. This data will be integrated into current scoring systems to prove it increases identification of patients who will suffer from breathlessness and poor quality of life following surgery. Creation and testing of a risk prediction tool, or 'score', requires complex statistical techniques; we are therefore working alongside specialist biostatisticians.

We hypothesise post-operative cardiac dysfunction significantly contributes to postoperative dyspnoea and a window of opportunity exists peri-operatively where targeted interventions could improve outcome. In this study, by incorporating BNP measurement into clinical risk prediction of post-operative dyspnoea in patients undergoing lung resection surgery can we improve prediction of a poor functional outcome?

Conditions
Lung Cancer
Medical subject headings
Lung Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Shortness of Breath

    Modified MRC score.

    Measured: 3 months

Secondary outcomes (1)
  1. Quality of life using quality of life questionnaire

    EQ-5D Qol questionnaire

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2019
  2. Study start1 Oct 2018
  3. Primary completionMar 2020 (estimated)
  4. Study completion1 Oct 2020 (estimated)

Resources

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
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03888937
Sponsor's protocol ID
0.6 18/LO/1563
Acronym
PROFILES
Status last verified
Mar 2019
First submitted
20 Feb 2019
Last updated
25 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by University of Glasgow 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Mar 2019. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dr B Lafferty, MBChB (0141 951 5000, brian.lafferty@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shortness of Breath (time frame: 3 months). 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 25 Mar 2019.

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