Clinical trial · Observational
Assessing the Accuracy of Seismofit® as an Estimate of VO2 Peak in Patients With Hepato-pancreato-biliary, Colorectal, and Gastro-oesophageal Cancer
NCT05831488CI-TRIAL-00065949VERVEunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Hepato-Biliary Carcinoma in Situ Nos | — | UNRESOLVED | — |
| Oesophageal Cancer | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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.
- timeFrame
- End of Trial (9 months)
- description
- Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and CPET-measured VO2 peak.
Secondary outcomes (4)
- measure
- Assess limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak
- timeFrame
- End of Trial (9 months)
- description
- Limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak (Bland-Alman analysis)
- measure
- Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in each surgical subgroup: HPB, gastro-oesophageal and colorectal cancer patients.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTetlow 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 40248106