Trial Title:
The Construction of Clinical Database and Multiomics Biobank Based on a Multicentral Prospective Cohort of Benign and Malignant Biliary Tract Diseases
NCT ID:
NCT05896956
Condition:
Biliary Tract Diseases
Gallbladder Cancer
Extrahepatic Bile Duct Cancer
Intrahepatic Cholangiocarcinoma
Biliary Tract Neoplasms
Gall Stone
Conditions: Official terms:
Cholangiocarcinoma
Gallbladder Neoplasms
Bile Duct Neoplasms
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallstones
Conditions: Keywords:
biliary tract diseases
gallbladder cancer
biliary tract neoplasms
biliary tract cancer
cohort study
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
no interventions
Description:
no interventions
Arm group label:
Patients with benign or malignant tumors of the biliary system
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.
Detailed 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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
74 Years
Healthy volunteers:
No
Start date:
July 1, 2023
Completion date:
June 30, 2027
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05896956
