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Trial Title:
Frailty in Patients With Gastrointestinal Cancer Who Are Undergoing Major Surgery
NCT ID:
NCT05694338
Condition:
Gastrointestinal Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Frailty
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Frailty survey
Description:
Frailty survey using the Clinical Risk Analysis Index (RAI-C).
Arm group label:
Major surgery for gastrointestinal cancer
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.
Criteria for eligibility:
Study pop:
Participants with gastrointestinal cancer who are referred for elective major surgery
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guthrie Medical Group
Address:
City:
E. Corning
Zip:
14830
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Rebekah Macfie, MD
Email:
Rebekah.Macfie@guthrie.org
Facility:
Name:
Robert Packer Hospital
Address:
City:
Sayre
Zip:
18840
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rebekah Macfie, MD
Email:
Rebekah.Macfie@guthrie.org
Start date:
March 13, 2023
Completion date:
March 1, 2026
Lead sponsor:
Agency:
The Guthrie Clinic
Agency class:
Other
Source:
The Guthrie Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05694338
