NCT03888937

Brief 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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

1.4 years

First QC Date

February 20, 2019

Last Update Submit

March 21, 2019

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Shortness of Breath

    Modified MRC score.

    3 months

Secondary Outcomes (1)

  • Quality of life using quality of life questionnaire

    3 months

Eligibility Criteria

Age16 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAny gender can take part in the study
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golden Jubilee National Hospital

Glasgow, g81 4dy, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Dr B Lafferty, MBChB

CONTACT

0141 951 5000brian.lafferty@nhs.net

Dr B Shelley, MBChB

CONTACT

0141 951 5000ben.shelley@glasgow.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

February 20, 2019

First Posted

March 25, 2019

Study Start

October 1, 2018

Primary Completion

March 1, 2020

Study Completion

October 1, 2020

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations

GB(1)