Status:
UNKNOWN
Association Between Body Composition and Digestive System Cancer Survival
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Digestive System Cancer
Eligibility:
All Genders
18-85 years
Brief Summary
Investigators intend to utilize clinical data from the Department of Oncology at Jiangsu Provincial People's Hospital to analyze changes in body composition in digestive system tumor patients before a...
Eligibility Criteria
Inclusion
- Male or female patients aged between 18 and 85 years old.
- Patients with histologically confirmed digestive tract cancers, such as esophageal cancer, gastric cancer, small intestinal cancer, colorectal cancer, as well as pancreatic cancer, liver cancer, gallbladder cancer, etc.
- Patients admitted for anti-tumor-related drug treatment.
- Expected survival period of more than three months.
- ECOG PS score: \< 4.
- No severe psychological disorders, physical disabilities, dementia, Alzheimer's disease, pulmonary tuberculosis, HIV/AIDS, or other infectious diseases.
- Patients must have sufficient organ and bone marrow function, meeting the following criteria:
- Hematological criteria:
- Hemoglobin (Hb) ≥ 90 g/L (without blood transfusion in the past 28 days). Absolute neutrophil count (ANC) ≥ 1.5×109/L. Peripheral blood monocytes \> 1500mm3. Platelet count (PLT) ≥ 100×109/L.
- Biochemical criteria:
- Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN). ALT and AST ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN. Creatinine (Cr) ≤ 1.5×ULN or creatinine clearance rate (CCr) ≥ 60 ml/min (Cockcroft-Gault formula).
- Coagulation function is sufficient, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.
- Women of childbearing potential must have a negative pregnancy test (serum or urine) within seven days before enrollment and must voluntarily use appropriate contraception methods during the observation period and within six months after the last dose.
- Signed informed consent.
Exclusion
- Female patients who are pregnant or breastfeeding.
- Patients with accompanying diseases, as judged by the investigator, pose a serious risk to patient safety or may affect the patient's ability to complete the study.
- Patients with poor compliance who refuse to undergo body composition measurements.
- Patients who experience a severe adverse event judged by the investigator as no longer suitable for continued participation in the study or those who become unexpectedly pregnant.
- Patients who are unwilling to continue in the clinical trial and insist on withdrawal.
- The investigator deems it necessary to terminate the study.
- Patients who were mistakenly included but did not meet the criteria.
Key Trial Info
Start Date :
April 17 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06054685
Start Date
April 17 2023
End Date
January 30 2025
Last Update
October 10 2023
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029