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NCT06443996Enrolling by invitation

Association of Sleep Quality and Mental Status With Early Recurrence and Prognosis of Colorectal Cancer

Effects of Sleep Quality and Mental Status on Early Postoperative Recurrence and Prognosis in Patients With Colorectal Cancer: a Prospective Observational Cohort Study

Source: ClinicalTrials.gov · Last updated 5 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
500 (estimated)
First submitted
15 May 2024
Start date
1 Aug 2023
Primary completion date
31 Dec 2026
Lead sponsor
Ma Yanlei
NCT number
NCT06443996

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 1 Aug 2023 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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;
  • Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, peritonitis, etc. requiring emergency surgery;
  • Have serious heart, lung, liver and kidney diseases, can not tolerate surgery;
  • 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;

Lab values

  • Active stage of liver disease or abnormal liver function, ALT, AST, TBIL is more than 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;

Age

  • Under 18 years of age or over 80 years of age;

Other

  • No radical operation was performed during the operation due to various reasons;
  • Merge other parts of the transfer;
  • Renal function damage, Cr ≥ 2 times the upper limit of normal value or BUN ≥ 2 times the upper limit of normal value;
  • The researchers considered that other candidates were not suitable for inclusion in this study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.