Assessing the Accuracy of Seismofit® as an Estimate of VO2 Peak in Patients With Hepato-pancreato-biliary, Colorectal, and Gastro-oesophageal Cancer (VERVE)

April 24, 2023 updated by: Royal Marsden NHS Foundation Trust

Our study aims to assess the relationship between the Seismofit® derived VO2 peak estimate and CPET-measured VO2 peak in patients who are having CPET as part of their preoperative workup. Our aim is to establish whether Seismofit® can be considered a cheaper, less resource intensive and better tolerated alternative to the CPET, or whether it might be useful as a screening tool to efficiently identify patients with exercise intolerance who may benefit from further characterisation by CPET.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Other: Non-Interventional

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - London, United Kingdom, SM25PT
    - Recruiting
    - The Royal Marsden NHS Foundation Trust
    - Contact:
      
      Mark Brandon-Grove
      
      Phone Number: 02031865416
      
      Email: Mark.Brandon-Grove@rmh.nhs.uk
    - Principal Investigator:
      
      Donald Milliken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

All HPB, gastro-oesophageal or colorectal cancer patients undergoing preoperative assessment for major surgery

Description

Inclusion Criteria:

Age ≥18
Scheduled for elective surgery for resection of HPB, colorectal or gastro-oesophageal primary or secondary cancer
Undergoing CPET as part of routine pre-operative investigations

Exclusion Criteria:

Subjects unable to give voluntary written informed consent to participate in this study
Diagnosis of moderate or worse stenosis or regurgitation of any cardiac valve
Previous aortic or mitral valve surgery, valvuloplasty or transcatheter valve implantation
Permanent pacemaker or cardiac resynchronisation device in situ
Diagnosis of severe pulmonary hypertension
Permanent atrial fibrillation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in HPB, gastro-oesophageal or colorectal cancer patients undergoing preoperative assessment for major surgery. Time Frame: End of Trial (9 months)	Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and CPET-measured VO2 peak.	End of Trial (9 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak Time Frame: End of Trial (9 months)	Limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak (Bland-Alman analysis)	End of Trial (9 months)
Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in each surgical subgroup: HPB, gastro-oesophageal and colorectal cancer patients. Time Frame: End of Trial (9 months)	Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and CPET-measured VO2 peak, as well as limits of agreement and bias (Bland-Altman analysis) in each surgical subgroup: HPB, gastro-oesophageal and colorectal cancer patients.	End of Trial (9 months)
Assess the relationship between Seismofit® -estimated VO2 peak and other CPET derived variables: o Anaerobic Threshold (AT) o Peak Power Output (PPO) o Ventilatory equivalents for carbon dioxide (VE/VCO2) Time Frame: End of Trial (9 months)	Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and the CPET-measured variables of AT, PPO and VE/VCO2	End of Trial (9 months)
Assess patient experience of the Seismofit® test using a brief measure that has been used previously in CPET research Time Frame: End of Trial (9 months)	Patient concern, comfort, and overall satisfaction of Seismofit® measurement compared with CPET.	End of Trial (9 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)