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

Colorectal Cancer Clinical Trial

— VERVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831488
• Other study ID #: CCR5651
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2023
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: March 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18

2. Scheduled for elective surgery for resection of HPB, colorectal or gastro-oesophageal primary or secondary cancer

3. Undergoing CPET as part of routine pre-operative investigations

Exclusion Criteria:

1. Subjects unable to give voluntary written informed consent to participate in this study

2. Diagnosis of moderate or worse stenosis or regurgitation of any cardiac valve

3. Previous aortic or mitral valve surgery, valvuloplasty or transcatheter valve implantation

4. Permanent pacemaker or cardiac resynchronisation device in situ

5. Diagnosis of severe pulmonary hypertension

6. Permanent atrial fibrillation

Related Conditions & MeSH terms

• Carcinoma in Situ
• Colorectal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Oesophageal Cancer
• Pancreatic Cancer

Intervention

Other:
• Non-Interventional
Non Interventional

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and CPET-measured VO2 peak.	End of Trial (9 months)
Secondary	Assess limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak	Limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak (Bland-Alman analysis)	End of Trial (9 months)
Secondary	Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in each surgical subgroup: HPB, gastro-oesophageal and colorectal cancer patients.	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)
Secondary	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)	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)
Secondary	Assess patient experience of the Seismofit® test using a brief measure that has been used previously in CPET research	Patient concern, comfort, and overall satisfaction of Seismofit® measurement compared with CPET.	End of Trial (9 months)