Frailty in Patients With Gastrointestinal Cancer Who Are Undergoing Major Surgery

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05694338
• Other study ID #: 2212-74
• Status: Recruiting
• Start date: March 13, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: March 2023
• Source: The Guthrie Clinic
• Contact: Burt Cagir, MD
• Phone: 15708874882
• Email: Burt.Cagir[@]guthrie.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Guthrie Medical Group	E. Corning	New York
United States	Robert Packer Hospital	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients considered frail assessed by Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher	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	Adverse outcomes after major surgery	Assess adverse outcomes postoperatively and if their is a correlation with the frailty score	30 days post-operative