Trial Title:
Application of Chromosomal Instability in Early Diagnosis of Biliary Tract Carcinoma
NCT ID:
NCT05845554
Condition:
Biliary Tract Carcinoma
Conditions: Official terms:
Carcinoma
Chromosomal Instability
Conditions: Keywords:
Biliary Tract Carcinoma
chromosomal instability
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
The extracted DNA from bile samples will be analyzed by BileCAD to determine the level of CIN.
Description:
The extracted gDNA from bile sample will be analyzed by BileCAD to determine the level of
CINs.
Arm group label:
Biliary tract carcinoma patients
Arm group label:
Non-cancer participants Patients
Summary:
Chromosomal instability (CIN) refers to ongoing chromosome segregation errors throughout
consecutive cell divisions. CIN is a hallmark of human cancer, and it is associated with
poor prognosis, metastasis, and therapeutic resistance. Analyzing CIN of the DNA
extracted from cast-off cells in bile samples seems a promising method for diagnosing,
monitoring, and predicting the prognosis of biliary tract carcinoma patients. CIN can be
assessed using experimental techniques such as bulk DNA sequencing, fluorescence in situ
hybridization (FISH), or conventional karyotyping. However, these techniques are either
time-consuming or non-specific. The investigators here intend to study whether a new
method named Bile Ultrasensitive Chromosomal Aneuploidy Detection (BileCAD), which is
based on low-coverage whole-genome sequencing, can be used to analyze CIN and microbial
infection analysis thus help diagnosing and treating biliary tract carcinoma patients.
Detailed description:
Biliary tract carcinoma account for about 3% of all digestive system tumors, with
potential high metastasis and invasion ability. Their early clinical symptoms lack
specificity, and they are often found in late stage with poor prognosis. CIN results from
errors in chromosome segregation during mitosis, leading to structural and numerical
chromosomal abnormalities. It will generate genomic heterogeneity that acts as a
substrate for natural selection. Furthermore, it is proved that tumors with aneuploidies
and polyploidy resulting from whole-genome doubling are related with metastasis,
treatment resistance, and decreased overall survival. It is estimated that 60%-80% of
human tumors exhibit chromosomal abnormalities suggestive of CIN. CIN positively
correlates with tumor stage and is enriched in relapsed as well as metastatic tumor
specimens. Due to the ubiquity of CIN in cancer cells, it is a potentially way to detect
CIN in the cast-off cells from the bile samples for diagnosing and monitoring biliary
tract carcinoma patients. BileCAD is a new method to detecting CIN in the DNA sample from
patients, including extracting DNA from bile, analyzing DNA by low-coverage whole-genome
sequencing, processing the data by bio-information techniques, and finally optimizing the
management of biliary tract carcinoma patients.The investigators intended to conduct a
prospective study by analyzing bile samples from gallbladder cancers and
cholangiocarcinoma patients and control groups that without any tumor in the Bile duct
and gallbladder or other organs to compare the specificity and sensitivity of BileCAD
test for diagnosing biliary tract carcinoma to other modalities, such as pathological
diagnosis. At the same time, the consistency of BileCAD microbial analysis results and
clinical microbial culture results was compared, so as to provide more reference for
clinical diagnosis.
Criteria for eligibility:
Study pop:
Patients diagnosed with biliary tract carcinoma or participants in control group in
Taizhou Hospital of Zhejiang Province, Taizhou First People's Hospital, The First
Affiliated Hospital of Wenzhou Medical University and Sir Run Run Shaw Hospital from Apr
2023 until the end of this study.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- No systemic therapy or biliary tract surgery before the trial.
- Gallstones, bile duct space, obstructive jaundice and other suspected patients with
biliary tract carcinoma.
- Male or female patients aged >= 18 years.
- Participants signed informed consent form.
Exclusion Criteria:
- Age under 18 years.
- Individuals unwilling to sign the consent form or unwilling to provide the medical
record.
- Individuals unwilling to participate in this trial.
- Individuals has any active autoimmune disease or history of autoimmune disease.
- Individuals have cardiac clinical symptoms or diseases that are not well controlled.
- Individuals have uncontrolled severe cerebrovascular, pulmonary and other diseases.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sir Run Run Shaw Hospital, School of Medicine，Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
xiao liang
Phone:
13588708506
Email:
srrshlx@zju.edu.cn
Facility:
Name:
Taizhou First People's Hospital
Address:
City:
Taizhou
Country:
China
Status:
Recruiting
Contact:
Last name:
ning mu
Phone:
15105861595
Email:
mnwsq@163.com
Facility:
Name:
Taizhou Hospital of Zhejiang Province
Address:
City:
Taizhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Fabiao zhang
Phone:
13706760105
Email:
zhangfabiao@enzemed.com
Facility:
Name:
First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
yunfeng Shan
Phone:
13857763998
Email:
shanyunfeng@wmu.edu.cn
Start date:
March 30, 2023
Completion date:
April 1, 2024
Lead sponsor:
Agency:
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Taizhou First People's Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Sir Run Run Shaw Hospital
Agency class:
Other
Source:
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05845554
