Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05896956 |
| Other study ID # |
CRGGCpros |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2023 |
| Est. completion date |
June 30, 2027 |
Study information
| Verified date |
June 2023 |
| Source |
RenJi Hospital |
| Contact |
Xu-Heng Sun, PhD |
| Phone |
+86 19117209107 |
| Email |
sunxh96[@]alumni.sjtu.edu.cn |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The aim of the study is to establishing a standardized biobank and a clinical information
database for patients with benign and malignant tumors of the biliary system. With follow-up
plans and advanced multiomics technology, a multiomics database for patients with benign and
malignant tumors of the biliary tract will be further established. Based on the above work,
real-world clinical research on the diagnosis and treatment of biliary tract tumors is about
to be carried out, and a high-standard cohort research foundation is laid for precision
therapy based on multiomics characteristics and molecular typing of biliary tract tumors.
Description:
1. Trial population From the date of commencement of the study, patients who presented to the
participating medical institutions in the study and were clinically diagnosed as benign or
malignant tumors of the biliary system, and who met the inclusion criteria and did not meet
any of the exclusion criteria, were enrolled in the study cohort after signing an informed
consent form.
Diagnostic criteria:
Patients with benign biliary tumors and biliary malignant tumors diagnosed by pathology, and
combined with clinical manifestations and imaging results, the first diagnosis and discharge
were diagnosed as patients with advanced biliary malignant tumors.
Inclusion Criteria:
1. Sign informed consent, have good compliance, and be willing to accept follow-up and
provide blood samples
2. Age 18-74 years old, gender is not limited
3. Clinical diagnosis of benign and malignant tumors of the biliary system, including
unoperated patients preliminarily diagnosed as benign and malignant tumors of the
biliary tract according to the results of imaging examinations and laboratory tests, or
pathological examination of patients treated with surgery confirmed as benign and
malignant tumors of the gallbladder
4. The primary tumor is located in the extrahepatic bile duct, intrahepatic bile duct,
gallbladder floor, gallbladder body, gallbladder neck or gallbladder duct
5. Karnofsky performance score greater than 50
Exclusion Criteria:
1. Patients with biliary malignant tumors, biliary malignant tumor foci are not primary
lesions.
2. Patients with biliary malignant tumors, combined with serious central nervous system
diseases, respiratory diseases, autoimmune diseases, chronic renal insufficiency and
other diseases, long-term use of immunosuppressants, combined with serious uncontrolled
infections
3. Patients with biliary malignant tumors, who also have active cardiovascular and
cerebrovascular diseases, have cerebrovascular accidents, myocardial infarction,
unstable angina pectoris, or grade II. or above congestive heart failure according to
the standards of the New York Heart Association, and require serious arrhythmias
requiring drug treatment
4. Patients with biliary malignant tumors, women of childbearing age who have a positive
blood pregnancy test or have not had a pregnancy test, pregnant or breastfeeding women
5. The patient is participating in other therapeutic clinical trials where treatment
measures cannot be clarified or treatment information cannot be collected 2. Sample size
calculation In this study, based on the retrospective cohort statistics of CRGGC study,
the average number of gallbladder cancer patients admitted to the hospital in previous
years, and the proportion of gallbladder cancer to biliary malignant tumors in previous
epidemiological investigations, the number of potential research subjects actually
diagnosed and treated by each participating unit was estimated, and the study sample
size was calculated. The number of cases of benign and malignant biliary tumors included
in the cohort of benign and malignant tumors of the biliary tract in this study is
expected to reach 60% of the total number of hospitalized patients admitted by the
participating units every year, and it is expected that no less than 250 patients with
benign and malignant tumors of the biliary tract will be enrolled every year, and 500
patients are expected to be enrolled within a baseline period of 2 years from the date
of the start of the study.
3. Specific research content The target population of this study is patients with benign and
malignant tumors of the biliary system, and the potential sample group is patients diagnosed
with benign and malignant tumors of the biliary system in the participating medical
institutions since December 31, 2022 and meet the criteria for inclusion and exclusion of the
study, and based on the retrospective cohort statistics of the CRGGC study, the average
number of patients with gallbladder cancer admitted to the hospital in previous years, as
well as the proportion of gallbladder cancer to biliary malignant tumors in previous
epidemiological investigations, the number of potential research subjects actually diagnosed
and treated by each participating unit was estimated. Calculate the study sample size. The
number of cases of benign and malignant biliary tumors included in the cohort of benign and
malignant tumors of the biliary tract in this study is expected to reach 60% of the total
number of hospitalized patients admitted by the participating units every year, and it is
expected that no less than 250 patients with benign and malignant tumors of the biliary tract
will be enrolled every year, and 500 patients are expected to be enrolled within a baseline
period of 2 years from the date of the start of the study. This study cohort is a
single-disease registry cohort, which does not involve grouping at the stage of establishing
the registration cohort, but in the data analysis stage, it can be divided into different
subgroups such as biliary malignant tumors, benign biliary tumors, gallbladder cancer,
intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma according to the
diagnosis of the included patients.
The research objectives of this study mainly include: (1) establishing a structured special
disease dataset standard for biliary tumors based on the diagnosis and treatment norms and
clinical pathways of biliary tract tumors; (2) Carry out clinical registration research on
biliary tumors and build a special disease cohort; (3) Establish a biobank of biliary tumor
cohort, including clinical diagnosis and treatment information such as patient diagnosis,
surgery, treatment, progression, survival, and biological samples such as tumor tissue and
body fluids; (4) Formulate standard operating specifications and sample quality control plans
for the collection, transportation, acceptance, preparation, preservation and detection of
biliary tumor biological specimen banks; (5) Formulate unified specimen bank management
standards and information and data management processes, promote the intelligent management
of specimen banks, and realize the linkage and integration of biobanks and specialized
disease cohort databases; (6) Combine biliary tumor database, biomics technology, such as
genomics, transcriptomics, proteomics, metabolomics technology, and big data acquisition,
storage analysis technology to complete the molecular typing of biliary tumors.
The outcome indicators of this study included overall survival time OS, recurrence-free
survival time PFS, R0 resection rate of patients treated with biliary malignancy, and
objective response rate ORR. The main measurement indicators of this study include the
patient's demographic information, past history, life history, admission, preoperative
examination information, surgery, postoperative situation, discharge, follow-up, outcome
indicators, routine examination results of biological samples and multi-omics sequencing
results, the above data are derived from the original records of prospective case
questionnaires, the original records of patients' electronic medical records and the
examination results of patients' biological samples. The outcome of follow-up was defined as
patients having been followed up for five years, or having a patient lost to follow-up or
dying during follow-up.
