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Frailty in Patients With Gastrointestinal Cancer Who Are Undergoing Major Surgery

A Descriptive and Comparative Analysis of Frailty in Rural Versus Urban Cancer Patients Undergoing Major Surgical Oncologic Procedures

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05694338
Enrollment
100
Registered
2023-01-23
Start date
2023-03-13
Completion date
2027-08-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Cancer

Brief summary

This research is for patients who have gastrointestinal cancer and have a planned major surgery. The purpose of this research is to identify cancer patients who may be at risk for frailty. Frailty is common in older adults and may include symptoms of weight loss, weakness, fatigue, low activity, slow walking and other illnesses. Frailty may increase the risk of problems after major surgery. The study will involve a survey, a blood sample, and a review of medical records.

Detailed description

The goals of the study are to: * Describe the rate of frailty in surgical cancer patients * Assess if frailty correlates with problems (adverse outcomes) after major surgery Participants taking part will be asked to complete a survey to assess frailty before surgery. The frailty survey is referred to as the Clinical Risk Analysis Index (RAI-C). Participants will have about 10 ml (2 teaspoons) of blood drawn before surgery. Blood tests will include complete blood count (CBC), vitamin A, creatinine, C-Reactive Protein (CRP), DHEA, albumin, and prealbumin.

Interventions

OTHERFrailty survey

Frailty survey using the Clinical Risk Analysis Index (RAI-C).

Sponsors

The Guthrie Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years old or older * histologically proven gastrointestinal malignancy * referral for elective major surgical procedures at including operations for upper and lower gastrointestinal malignancies and hepato-pancreato-biliary * referral for neoadjuvant treatment followed by any of the above major surgical procedures

Exclusion criteria

* under 18 years * pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Percent of patients considered frail assessed by Clinical Risk Analysis Index (RAI-C) Scores of 21 or higherpre-operativeAssess Clinical Risk Analysis Index (RAI-C) Scores in rural patients referred for major abdominal surgeries. Survey values will be added to yield a final RAI-C score between 0 and 81. Percent of patients considered frail will be defined as Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher

Secondary

MeasureTime frameDescription
Adverse outcomes after major surgery30 days post-operativeAssess adverse outcomes postoperatively and if their is a correlation with the frailty score

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRebekah Macfie, MD

The Guthrie Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026