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Trial Title:
Assessing the Accuracy of Seismofit® as an Estimate of VO2 Peak in Patients With Hepato-pancreato-biliary, Colorectal, and Gastro-oesophageal Cancer
NCT ID:
NCT05831488
Condition:
Hepato-Biliary Carcinoma in Situ Nos
Pancreatic Cancer
Colorectal Cancer
Gastric Cancer
Oesophageal Cancer
Conditions: Official terms:
Carcinoma in Situ
Esophageal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional
Description:
Non Interventional
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.
Criteria for eligibility:
Study pop:
All HPB, gastro-oesophageal or colorectal cancer patients undergoing preoperative
assessment for major surgery
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Royal Marsden NHS Foundation Trust
Address:
City:
London
Zip:
SM25PT
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Mark Brandon-Grove
Phone:
02031865416
Email:
Mark.Brandon-Grove@rmh.nhs.uk
Investigator:
Last name:
Donald Milliken
Email:
Principal Investigator
Start date:
March 1, 2023
Completion date:
March 1, 2024
Lead sponsor:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Source:
Royal Marsden NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05831488
