Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery

NCT06267378 | Recruiting

• 1 other identifier: 1174/2022/NCTS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study team will look at 3 new tests that will make it easier to measure frailty in patients awaiting surgery for cancer and compare them against standard clinical measures of frailty in a pilot study. The expected outcome is that evidence will be collated in order to apply for a major grant to look at improving the care of frail patients with cancer in the future.

Conditions

Bowel Cancer

Outcome Measures

Primary Outcomes (3)

• The sensitivity & specificity of digital motion data for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events

  The development of biochemical assessments of frailty could also provide valuable information to guide the treatment of the older patient although there are very few that have been validated for clinical use across a range of settings.

  01/12/2029

• The sensitivity & specificity of tissue senescence for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events

  A further potential measure of frailty is tissue levels of senescence. Senescent cells are rare in the tissues of young organisms but become more common as tissues age, especially in adipose tissue, muscle and skin (Tchkonia et al., 2010). Both ageing and frailty are associated with cellular senescence, a mechanism of irreversible cell cycle arrest caused by persistent stress and damage, which contributes to the process of ageing, frailty and a range of diseases (Xu et al., 2018; Hickson et al., 2019). Senescent cells are causal to a wide range of diseases such as arthritis, arteriosclerosis and dementia and are also linked to the development of frailty in animal models.

  01/12/2029

• The sensitivity & specificity of blood based biomarkers for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events

  A simple, validated biomarker of frailty, capable of identification of patients who are at an increased risk of adverse outcomes from surgery, would be of great value in the surgical decision-making process.

  01/12/2029

Secondary Outcomes (7)

• Blood biomarker correlation (baseline and post operative) with baseline frailty and poor outcomes (including length of stay and adverse events)

  01/12/2029

• Adverse events related to surgery assessed CTCAE classifications

  01/12/2029

• Tissue senescence correlation between baseline frailty and poor outcomes (including length of stay and adverse events)

  01/12/2029

• Digital mobility outcomes correlation with baseline frailty and poor outcomes (including length of stay and adverse events)

  01/12/2029

• Physical function assessment after surgery at 6 weeks, 3 months using the WHO DAS 2.0.

  01/12/2029

Interventions

Frailty measure OTHER

All participants will be asked to complete baseline assessments and a blood test. 30 participants out of the 100 will be selected to wear a digital motion device before their surgery for seven days. (15 participants will be non-frail and 15 patients will be frail). Where possible, all baseline assessments will be scheduled to coincide with a routine clinic/hospital visit. The first assessment will complete functional, frailty, nutritional, and quality of life questionnaires. A blood test will be taken for baseline tests and metabolomic assessment. Participants who opt into having a digital motion device will also be shown how to use the device and will wear this for seven days. Written instructions to fit the device will also be given.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Gastrointestinal cancer patients

You may qualify if:

• Male or female.
• Aged 70 years and over.
• Patients with a diagnosis of primary operable colorectal cancer where treatment includes a planned curative surgical procedure.
• About to undergo elective surgery for cancer.
• Mental capacity to consent.

You may not qualify if:

• Patients with unresectable cancer.
• Patients presenting as an emergency.
• Patients who are having chemotherapy or radiotherapy before their surgery.

Sponsors & Collaborators

• Doncaster And Bassetlaw Hospitals NHS Foundation Trust: lead

Study Sites (1)

Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

Doncaster, South Yorkshire, DN2 5LT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples and Tissue collection from the resected specimen

MeSH Terms

Conditions

Intestinal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases

Study Officials

• Jayan George

  Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayan George

CONTACT

01302 366666; jayan.george@nhs.net

Emma Stoner

CONTACT

01302 644073; dbth.clinicalresearch@nhs.net

Study Design

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

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: February 20, 2024
• Study Start: August 30, 2023
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 8, 2024

Record last verified: 2023-10

Locations

GB (1)