CClinicalTrials.gg
Status unknownNCT03888937PROFILESUpdated Mar 25, 2019

bnP for pRediction of Outcome FollowIng Lung rEsection Surgery

An observational study in Lung Cancer, sponsored by University of Glasgow. Status unknown at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-03-25.

Sponsored by University of Glasgow · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
16 Years and older
Sex
All
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Study 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 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?

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Conditions studied

  • Lung Cancer
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In context

Lead sponsor

University of Glasgow is the lead sponsor of 142 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Sampling method
Probability sample

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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Shortness of Breath

    Modified MRC score.

    Time frame: 3 months

Secondary outcomes

  1. Quality of life using quality of life questionnaire

    EQ-5D Qol questionnaire

    Time frame: 3 months

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03888937
Lead sponsor
University of Glasgow
Responsible party
Dr Ben Shelley (Chief Investigator, University of Glasgow) — Principal investigator
First posted
Mar 25, 2019
Start date
Oct 1, 2018
Primary completion
Mar 2020 (estimated)
Completion
Oct 1, 2020 (estimated)
Last update
Mar 25, 2019

Study contacts

Dr B Lafferty, MBChB
Contact
brian.lafferty@nhs.net
0141 951 5000
Dr B Shelley, MBChB
Contact
ben.shelley@glasgow.ac.uk
0141 951 5000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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