Colorectal CancerNCT05879861
Development and Validation of a Risk Prediction Model for Preoperative Frailty in Elderly Patients With Colorectal Cancer
An observational study of Colorectal Cancer, run by Zunyi Medical College at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 364 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yongmei Zhang
Zunyi, Guizhou, 563000
Yongmei Zhang, 13885257269, hulizym@yeah.net
About this study
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.
- Conditions
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Status of frailty
Status of frailty will be assessed by Fried Scale
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Aug 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Retrospective
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zunyi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongmei Zhang, Zunyi Medical College
- Investigators
- Yongmei Zhang, Study director, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879861
- Sponsor's protocol ID
- ZSKHZ Zi (2022) no. 337
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Risk Prediction Model for Preoperative Frailty in Elderly Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05879861
- Acronym / sponsor ID
- ZSKHZ Zi (2022) no. 337
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Zunyi Medical CollegeUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 30 May 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Status of frailty
Time frame: 1 day
Status of frailty will be assessed by Fried Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
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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.
Yongmei Zhang study director
Zunyi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Zunyi Medical College at 1 site in China.
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 7 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: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongmei Zhang (13885257269, hulizym@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Status of frailty (time frame: 1 day). 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 30 May 2023.