NCT05831488

Brief 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.

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
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

January 17, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 26, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

January 17, 2023

Last Update Submit

April 24, 2023

Conditions

Hepato-Biliary Carcinoma in Situ NosPancreatic CancerColorectal CancerGastric CancerOesophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Assess limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak

    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.

    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)

    End of Trial (9 months)

  • Assess patient experience of the Seismofit® test using a brief measure that has been used previously in CPET research

    End of Trial (9 months)

Interventions

Non-InterventionalOTHER

Non Interventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, SM25PT, United Kingdom

RECRUITING

Related Publications (1)

  • Tetlow N, Devendra P, Waiting J, Aresu M, Glover A, Rooms M, Jhanji S, Milliken D. Assessing the accuracy of Seismofit(R) as an estimate of preoperative maximal oxygen consumption in patients with hepato-pancreato-biliary, colorectal, and gastro-oesophageal cancer. BJA Open. 2025 Apr 8;14:100395. doi: 10.1016/j.bjao.2025.100395. eCollection 2025 Jun.

    PMID: 40248106DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsColorectal NeoplasmsStomach NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2023

First Posted

April 26, 2023

Study Start

March 1, 2023

Primary Completion

October 1, 2023

Study Completion

March 1, 2024

Last Updated

April 26, 2023

Record last verified: 2023-01

Locations

GB(1)