Hepato-Biliary Carcinoma in Situ NosVERVENCT05831488
Assessing the Accuracy of Seismofit® as an Estimate of VO2 Peak in Patients With Hepato-pancreato-biliary, Colorectal, and Gastro-oesophageal Cancer
An observational study of Hepato-Biliary Carcinoma in Situ Nos and Pancreatic Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepato-Biliary Carcinoma in Situ Nos, Pancreatic Cancer, Colorectal Cancer
- What is being tested?
- Non-Interventional
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All HPB, gastro-oesophageal or colorectal cancer patients undergoing preoperative assessment for major surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden NHS Foundation Trust
London, SM25PT
Mark Brandon-Grove, 02031865416, Mark.Brandon-Grove@rmh.nhs.uk
Donald Milliken
About this study
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
- Hepato-Biliary Carcinoma in Situ Nos, Pancreatic Cancer, Colorectal Cancer, Gastric Cancer, Oesophageal Cancer
- Being tested
- Non-Interventional
- Medical subject headings
- Pancreatic Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non Interventional
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of Trial (9 months)
Secondary outcomes (4)
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)
Measured: 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.
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.
Measured: 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)
Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and the CPET-measured variables of AT, PPO and VE/VCO2
Measured: End of Trial (9 months)
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.
Measured: End of Trial (9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Mar 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepato-Biliary Carcinoma in Situ NosStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831488
- Sponsor's protocol ID
- CCR5651
- Acronym
- VERVE
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40248106
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Accuracy of Seismofit® as an Estimate of VO2 Peak in Patients With Hepato-pancreato-biliary, Colorectal, and Gastro-oesophageal Cancer
- ClinicalTrials.gov ID
- NCT05831488
- Acronym / sponsor ID
- VERVE / CCR5651
- Conditions
- Hepato-Biliary Carcinoma in Situ Nos, Pancreatic Cancer, Colorectal Cancer, Gastric Cancer, Oesophageal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All HPB, gastro-oesophageal or colorectal cancer patients undergoing preoperative assessment for major surgery
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNon Interventional | Other | – |
Primary outcome
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.
4 secondary outcomes
Assess limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak
Time frame: 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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Derived from this study: PubMed 40248106Tetlow 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.
Related trials for Hepato-Biliary Carcinoma in Situ Nos
Not yet recruitingObservational study
Cohort Study to eLucidAte Causes, Behaviour and Outcomes of gastRo Intestinal Tract Cancers in the Young
Colorectal Cancer, Gastro-oesophageal Adenocarcinoma
RecruitingPhase 2
Ph II Intraperitoneal Paclitaxel + System Therapy in GI Ca w/Peritoneal Carcinomatosis (STOPGAP-B)
Esophageal Carcinoma, Gastric Cancer (Diagnosis)
Not yet recruiting
SCINTIX [BgRT} Using RMRS in Solid and Soft Tissue Tumors
Thoracic Cancer, Head and Neck Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The Royal Marsden NHS Foundation Trust
London, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepato-Biliary Carcinoma in Situ Nos and Pancreatic Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: End of Trial (9 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05831488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.