Gallbladder cancer
Conditions
Interventions
Gold Standard:histopathological diagnosis of surgery or tissue biopsy
Index test:ctDNA mutation spectrum
Sponsors
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with gallbladder mass found by imaging examination, highly suspected of gallbladder cancer, and planned to undergo surgery or biopsy to confirm the pathology; 2. According to the RECIST version 1.1 evaluation criteria, there is at least one measurable lesion (the longest diameter of the target lesion in spiral CT examination is >=10mm); 3. Patients who voluntarily participate in this experimental project and have good compliance; if the patient cannot read or sign, the informed consent form must be signed by a legal representative under the condition of the patient's informed consent. For patients who are unable to express consent, the above-mentioned introduction and explanation shall be provided to their legal representative, and the legal representative shall sign the informed consent; 4. Aged 18-80 years; 5. The vital signs are stable, and the ECOG score is 0-1; 6. Liver function AST and ALT 3x10^9/L, absolute granulocyte count >= 1.5x10^9/ L; platelets >= 75x10^9/L; hemoglobin >= 90 g/L; creatinine clearance >= 60ml/min; total bilirubin <= 3 times normal upper limit of value (ULN); 7. Patients of childbearing age and their spouses are willing to take contraceptive measures, and female patients must have a negative pregnancy test (serum or urine) within 7 days before enrollment.
Exclusion criteria
Exclusion criteria: 1. Received molecular targeted therapy, immunotherapy, or anti-tumor chemoradiotherapy before this study; 2. History of other malignant tumors other than gallbladder malignant tumor; 3. Associated with other serious diseases, including but not limited to: uncontrolled congestive heart failure (NYHA class III or IV), unstable angina pectoris, poorly controlled arrhythmia, uncontrolled moderate or above hypertension (SBP > 160mmHg or DBP > 100mmHg); 4. Uncontrolled diabetes; 5. Active infection; 6. Active autoimmune disease requiring long-term use of steroids; 7. Patients who have received allogeneic transplantation; 8. Mental illness that affects informed consent and/or protocol compliance; 9. There are serious diseases that other researchers consider unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of ctDNA based diagnosis model;Specificity of ctDNA based diagnosis model; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival;Sensitivity of ctDNA based progression model;Specificity of ctDNA based progression model; | — |
Countries
China
Contacts
Public ContactLiu Yingbin
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed