Frailty in Patients With Gastrointestinal Cancer Who Are Undergoing Major Surgery

September 8, 2026 updated by: The Guthrie Clinic

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • East Corning, New York, United States, 14830
        • Guthrie Medical Group
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Robert Packer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with gastrointestinal cancer who are referred for elective major surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Major surgery for gastrointestinal cancer
Patients with gastrointestinal cancer who are scheduled for major surgery
Other: Frailty survey
Frailty survey using the Clinical Risk Analysis Index (RAI-C).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of patients considered frail assessed by Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher
Time Frame: pre-operative
Assess 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
pre-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse outcomes after major surgery
Time Frame: 30 days post-operative
Assess adverse outcomes postoperatively and if their is a correlation with the frailty score
30 days post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Guthrie Clinic

Investigators

  • Principal Investigator: Rebekah Macfie, MD, The Guthrie Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2212-74

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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