Colorectal CancerNCT06443996
Association of Sleep Quality and Mental Status With Early Recurrence and Prognosis of Colorectal Cancer
An observational study of Colorectal Cancer and Sleep Quality, run by Ma Yanlei at 1 site in China.
Trial summary
This is a prospective observational cohort study to explore the effects of sleep quality and mental status on early postoperative recurrence and prognosis in patients with colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Sleep Quality, Mental Status Change
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were diagnosed with colorectal cancer by histopathology at the Affiliated Cancer Hospital of Fudan University and underwent surgery for colorectal cancer at the Affiliated Cancer Hospital of Fudan University
Who may be able to join
- Preoperative fibrocolonoscopy and pathological examination confirmed colorectal cancer;
- Age 18 ~ 80 years old;
- Baseline clinical stage TNM Ⅰ to Ⅲ : cT1-4N0-2M0 (AJCC-8 version);
- The United States Eastern Oncology Consortium (ECOG) physical status score was 0 to 2 points;
- Laboratory examination results before admission met the following surgical conditions: neutrophil (ANC) ≥1.5×109/L, platelets (PLT) ≥ 100×109/L, total bilirubin (TBI) ≤1.5× upper limit of normal (2mg/dl), alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2× upper limit of normal; Coagulation parameters in the normal range;
- Able to complete the required research questionnaire independently or with the assistance of the researcher;
- Patients were willing to undergo regular follow-up after surgery and had no psychological, family, social, or geographic constraints that affected protocol compliance and follow-up time;
- Patients and their families can understand and are willing to participate in this clinical study, and sign informed consent.
Who cannot join
- Under 18 years of age or over 80 years of age;
- Have a family history of severe mental illness;
- People with mental illness or intellectual disability who cannot correctly describe their feelings;
- The patient has severe systemic infection;
- No radical operation was performed during the operation due to various reasons;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, peritonitis, etc. requiring emergency surgery;
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- Merge other parts of the transfer;
- Have serious heart, lung, liver and kidney diseases, can not tolerate surgery;
- Active stage of liver disease or abnormal liver function, ALT, AST, TBIL is more than 2 times the upper limit of normal value;
- Renal function damage, Cr ≥ 2 times the upper limit of normal value or BUN ≥ 2 times the upper limit of normal value;
- The subject's blood white blood cells are lower than the lower limit of normal, or platelets are lower than the lower limit of normal, or there are other blood system diseases;
- Severe coagulation mechanism disorder and bleeding tendency;
- Serious uncontrolled medical disease, recent history of myocardial infarction (within 3 months); Acute infection;
- Patients with uncontrolled severe hypertension and severe diabetes after intervention;
- The researchers considered that other candidates were not suitable for inclusion in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Sleep Quality and Mental Status on Early Postoperative Recurrence and Prognosis in Patients With Colorectal Cancer: a Prospective Observational Cohort Study
This is a prospective observational cohort study to explore the effects of sleep quality and mental status on early postoperative recurrence and prognosis in patients with colorectal cancer.
Read the detailed description
Evidence of evidence-based medicine shows that patients with malignant tumors have heavy psychological pressure after disease, and are prone to different degrees of sleep disorders and mental health problems, which often affect the progression and prognosis of the primary tumor. Previous studies have reported that baseline sleep quality was independently associated with risk of progression, risk of death, and response to treatment in patients with metastatic colorectal cancer before and during chemotherapy. Surgery, as a stressor, often causes obvious psychological stress reactions in patients, resulting in varying degrees of sleep disorders and poor mental performance, which may also become a factor affecting the recurrence and prognosis of patients. Therefore, the Department of Colorectal Surgery, Affiliated Cancer Hospital of Fudan University intends to conduct a prospective observational cohort study on the effects of sleep quality and mental state on early postoperative recurrence and prognosis of patients with colorectal cancer, in order to explore the effects of sleep quality and mental state on early postoperative recurrence and prognosis of patients with colorectal cancer.
- Conditions
- Colorectal Cancer, Sleep Quality, Mental Status Change
- Medical subject headings
- Colorectal Neoplasms, Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
The duration between the date after surgery to the date of any recurrence or death firstly
Measured: through study completion, an average of 1 year
Overall Survival
Time from the start of surgical randomization to death (from any cause)
Measured: through study completion, an average of 1 year
Effect of sleep quality and mental state on early recurrence and prognosis of patients with colorectal cancer after surgery
The correlation of GAD-7 scale score, PHQ-9 scale score and ESAS scale score with Disease-free survival (DFS), Overall Survival and tumor-free survival rate of patients was analyzed
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Tumor markers CEA, CA19-9 was used to determine recurrence in patients with colorectal cancer enrolled in the study.
Tumor markers CEA, CA19-9 was used to determine recurrence in patients with colorectal cancer enrolled in the study. 1, 3, 6, 12, 18, 24 months after the operation until the observation endpoint appeared.
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Enteroscope was used to determine recurrence in patients with colorectal cancer enrolled in the study.
Enteroscope was used to determine recurrence in patients with colorectal cancer enrolled in the study. 1, 3, 6, 12, 18, 24 months after the operation until the observation endpoint appeared.
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Physical examination was used to determine recurrence in patients with colorectal cancer
Physical examination was used to determine recurrence in patients with colorectal cancer.1, 3, 6, 12, 18, 24 months after the operation until the observation endpoint appeared.
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ma Yanlei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ma Yanlei, Fudan University
- Investigators
- Yanlei Ma, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443996
- Sponsor's protocol ID
- FDCRC97-MYL
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 5 Jun 2024
- 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 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Quality and Mental Status on Early Postoperative Recurrence and Prognosis in Patients With Colorectal Cancer: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06443996
- Acronym / sponsor ID
- FDCRC97-MYL
- Conditions
- Colorectal Cancer, Sleep Quality, Mental Status Change
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ma YanleiUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jun 2024 (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 is a prospective observational cohort study to explore the effects of sleep quality and mental status on early postoperative recurrence and prognosis in patients with colorectal cancer.
Detailed description
Evidence of evidence-based medicine shows that patients with malignant tumors have heavy psychological pressure after disease, and are prone to different degrees of sleep disorders and mental health problems, which often affect the progression and prognosis of the primary tumor. Previous studies have reported that baseline sleep quality was independently associated with risk of progression, risk of death, and response to treatment in patients with metastatic colorectal cancer before and during chemotherapy. Surgery, as a stressor, often causes obvious psychological stress reactions in patients, resulting in varying degrees of sleep disorders and poor mental performance, which may also become a factor affecting the recurrence and prognosis of patients. Therefore, the Department of Colorectal Surgery, Affiliated Cancer Hospital of Fudan University intends to conduct a prospective observational cohort study on the effects of sleep quality and mental state on early postoperative recurrence and prognosis of patients with colorectal cancer, in order to explore the effects of sleep quality and mental state on early postoperative recurrence and prognosis of patients with colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were diagnosed with colorectal cancer by histopathology at the Affiliated Cancer Hospital of Fudan University and underwent surgery for colorectal cancer at the Affiliated Cancer Hospital of Fudan University
Key inclusion criteria (8 listed)
- Preoperative fibrocolonoscopy and pathological examination confirmed colorectal cancer;
- Age 18 ~ 80 years old;
- Baseline clinical stage TNM Ⅰ to Ⅲ : cT1-4N0-2M0 (AJCC-8 version);
- The United States Eastern Oncology Consortium (ECOG) physical status score was 0 to 2 points;
- Laboratory examination results before admission met the following surgical conditions: neutrophil (ANC) ≥1.5×109/L, platelets (PLT) ≥ 100×109/L, total bilirubin (TBI) ≤1.5× upper limit of normal (2mg/dl), alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2× upper limit of normal; Coagulation parameters in the normal range;
Key exclusion criteria (15 listed)
- Under 18 years of age or over 80 years of age;
- Have a family history of severe mental illness;
- People with mental illness or intellectual disability who cannot correctly describe their feelings;
- The patient has severe systemic infection;
- No radical operation was performed during the operation due to various reasons;
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
Disease-free survival (DFS)
Time frame: through study completion, an average of 1 year
The duration between the date after surgery to the date of any recurrence or death firstly
Overall Survival
Time frame: through study completion, an average of 1 year
Time from the start of surgical randomization to death (from any cause)
Effect of sleep quality and mental state on early recurrence and prognosis of patients with colorectal cancer after surgery
Time frame: through study completion, an average of 1 year
The correlation of GAD-7 scale score, PHQ-9 scale score and ESAS scale score with Disease-free survival (DFS), Overall Survival and tumor-free survival rate of patients was analyzed
3 secondary outcomes
Tumor markers CEA, CA19-9 was used to determine recurrence in patients with colorectal cancer enrolled in the study.
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Enteroscope was used to determine recurrence in patients with colorectal cancer enrolled in the study.
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Physical examination was used to determine recurrence in patients with colorectal cancer
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
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 5 Jun 2024.
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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.
Yanlei Ma, PhD principal investigator
Fudan University
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 and Sleep Quality, run by Ma Yanlei 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 8 inclusion and 15 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: enrolling by invitation, as of the sponsor's last update on 5 Jun 2024. 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?
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?
Disease-free survival (DFS) (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 5 Jun 2024.