- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05879861
Development and Validation of a Risk Prediction Model for Preoperative Frailty in Elderly Patients With Colorectal Cancer
May 19, 2023 updated by: Yongmei Zhang, Zunyi Medical College
Fried Scale and its related scales were used to analyze the status and risk factors of preoperative frailty in elderly patients with colorectal cancer.
R software was used to construct a risk prediction model for preoperative frailty in elderly patients with colorectal cancer, and its validity and stability were verified in clinical practice.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
364
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yongmei Zhang
- Phone Number: 13885257269
- Email: hulizym@yeah.net
Study Locations
-
-
Guizhou
-
Zunyi, Guizhou, China, 563000
- Recruiting
- Yongmei Zhang
-
Contact:
- Yongmei Zhang
- Phone Number: 13885257269
- Email: hulizym@yeah.net
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients who met the diagnostic criteria of colorectal cancer in Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer 2020 Edition and underwent surgery.
Description
Inclusion Criteria:
- patients who met the diagnostic criteria of colorectal cancer in Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer 2020 Edition and underwent surgery;
- patients aged ≥60 years old ;
- patients who are clearly conscious, able to understand instructions, communicate normally, and complete the physical activity ability test without the assistance of others;
- patients who gave informed consent and volunteered to participate in the study.
Exclusion Criteria:
- patients with limb joint disease and lower limb pain;
- patients with serious heart, liver, kidney diseases could not complete the test;
- patients with visual impairment and hearing impairment;
- patients with a history of mental illness or drug dependence;
- taking antidepressants, levodopa/carbidopa, donepezil hydrochloride and other drugs ;
- patients who received preoperative radiotherapy and chemotherapy;
- Patients with hypothyroidism, Parkinson's disease, stroke and other diseases.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Status of frailty
Time Frame: 1 day
|
Status of frailty will be assessed by Fried Scale
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yongmei Zhang, Zunyi Medical College
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)
August 1, 2022
Primary Completion (Estimated)
July 31, 2025
Study Completion (Estimated)
July 31, 2025
Study Registration Dates
First Submitted
May 19, 2023
First Submitted That Met QC Criteria
May 19, 2023
First Posted (Actual)
May 30, 2023
Study Record Updates
Last Update Posted (Actual)
May 30, 2023
Last Update Submitted That Met QC Criteria
May 19, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZSKHZ Zi (2022) no. 337
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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