Gastrointestinal CancerNCT05694338
Frailty in Patients With Gastrointestinal Cancer Who Are Undergoing Major Surgery
An observational study of Gastrointestinal Cancer, run by The Guthrie Clinic at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Frailty survey
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Mar 2023to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with gastrointestinal cancer who are referred for elective major surgery
Who may be able to join
- 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
Who cannot join
- under 18 years
- pregnant women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Guthrie Medical Group
East Corning, New York, 14830
Robert Packer Hospital
Sayre, Pennsylvania, 18840
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Frailty survey
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty surveyOther
Frailty survey using the Clinical Risk Analysis Index (RAI-C).
| Study group | Role | What they receive |
|---|---|---|
| Major surgery for gastrointestinal cancer | Patients with gastrointestinal cancer who are scheduled for major surgery Receives: Other: Frailty survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre-operative
Secondary outcomes (1)
Adverse outcomes after major surgery
Assess adverse outcomes postoperatively and if their is a correlation with the frailty score
Measured: 30 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start13 Mar 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebekah Macfie, MD, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694338
- Sponsor's protocol ID
- 2212-74
- Status last verified
- Sep 2026
- First submitted
- 12 Jan 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive and Comparative Analysis of Frailty in Rural Versus Urban Cancer Patients Undergoing Major Surgical Oncologic Procedures
- ClinicalTrials.gov ID
- NCT05694338
- Acronym / sponsor ID
- 2212-74
- Conditions
- Gastrointestinal Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major surgery for gastrointestinal cancer | – | Other: Frailty surveyPatients with gastrointestinal cancer who are scheduled for major surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with gastrointestinal cancer who are referred for elective major surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- under 18 years
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frailty surveyFrailty survey using the Clinical Risk Analysis Index (RAI-C). | Other | Major surgery for gastrointestinal cancer |
Primary outcome
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
1 secondary outcome
Adverse outcomes after major surgery
Time frame: 30 days post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebekah Macfie, MD principal investigator
The Guthrie Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Cancer, run by The Guthrie Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients considered frail assessed by Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher (time frame: pre-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.