Colorectal CancerNCT05915637
Investigation of Preoperative Frailty in Elderly Patients With Colorectal Cancer and Correlation Between Preoperative Frailty and Early Postoperative Prognosis
An observational study of Colorectal Cancer, run by Zunyi Medical College at 1 site in China.
Trial summary
To investigate and analyze the status of preoperative frailty and its influencing factors in elderly patients with colorectal cancer using FRALL scale and other related scales, and to explore the correlation between preoperative frailty and early prognosis in elderly patients with colorectal cancer, so as to attract… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 336 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 1 Nov 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Colorectal cancer was diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer (2020 edition) and planned to undergo elective laparoscopic radical resection of colorectal cancer
Who may be able to join
- age ≥60 years old;
- Colorectal cancer was diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer (2020 edition) and planned to undergo elective laparoscopic radical resection of colorectal cancer;
- able to complete physical assessment without communication barriers;
- voluntarily participated in this study after informed consent.
Who cannot join
- taking antidepressants, levodopa, donepezil hydrochloride and other drugs;
- patients with preoperative colorectal cancer surgery or neoadjuvant therapy;
- patients with TNM stage Ⅳ;
- complicated with other malignant tumors except primary skin cancer or melanoma.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate and analyze the status of preoperative frailty and its influencing factors in elderly patients with colorectal cancer using FRALL scale and other related scales, and to explore the correlation between preoperative frailty and early prognosis in elderly patients with colorectal cancer, so as to attract the attention of medical staff to preoperative frailty in this population and provide a preliminary research basis for the study of frailty intervention in these patients.
- 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.
Fatigue Assessment
Status of frailty will be assessed by FRALL Scale
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Sep 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
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
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zunyi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongmei Zhang, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915637
- Sponsor's protocol ID
- KLLY-2021-025
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 23 Jun 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 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Preoperative Frailty in Elderly Patients With Colorectal Cancer and Correlation Between Preoperative Frailty and Early Postoperative Prognosis
- ClinicalTrials.gov ID
- NCT05915637
- Acronym / sponsor ID
- KLLY-2021-025
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Zunyi Medical CollegeUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 23 Jun 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.
To investigate and analyze the status of preoperative frailty and its influencing factors in elderly patients with colorectal cancer using FRALL scale and other related scales, and to explore the correlation between preoperative frailty and early prognosis in elderly patients with colorectal cancer, so as to attract the attention of medical staff to preoperative frailty in this population and provide a preliminary research basis for the study of frailty intervention in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal cancer was diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer (2020 edition) and planned to undergo elective laparoscopic radical resection of colorectal cancer
Key inclusion criteria (4 listed)
- age ≥60 years old;
- Colorectal cancer was diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer (2020 edition) and planned to undergo elective laparoscopic radical resection of colorectal cancer;
- able to complete physical assessment without communication barriers;
- voluntarily participated in this study after informed consent.
Key exclusion criteria (4 listed)
- taking antidepressants, levodopa, donepezil hydrochloride and other drugs;
- patients with preoperative colorectal cancer surgery or neoadjuvant therapy;
- patients with TNM stage Ⅳ;
- complicated with other malignant tumors except primary skin cancer or melanoma.
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
Fatigue Assessment
Time frame: 7 days
Status of frailty will be assessed by FRALL Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 4 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: finished, as of the sponsor's last update on 23 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fatigue Assessment (time frame: 7 days). 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 23 Jun 2023.