Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05237193
Status:
UNKNOWN
Last Update Posted:
2023-01-17
First Post:
2022-01-24
Brief Title:
A Prospective Study of UCAD for Diagnosing Benign or Malignant Biliary Obstruction and Follow-up
Sponsor:
Xinhua Hospital Shanghai Jiao Tong University School of Medicine
Organization:
Xinhua Hospital Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
A Prospective Multi-centre Single-blinded Study of UCAD for Diagnosing Benign or Malignant Biliary Obstruction and Follow-up
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 bile tract exfoliated cells in bile samples seems a promising method for diagnosing monitoring and predicting the prognosis of patients with malignant biliary obstruction including biliary tract cancer BTC pancreatic head carcinoma 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 Ultrasensitive Chromosomal Aneuploidy Detection UCAD which is based on low-coverage whole-genome sequencing can be used to analyze CIN thus helping diagnose malignant biliary obstruction and assessing follow-up
Detailed Description:
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 to 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 non-invasive way to detect CIN in the bile tract exfoliated cells in bile samples for diagnosing and monitoring malignant biliary obstruction patients UCAD is a new method to detect 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 malignant biliary obstruction patients The investigators intended to conduct a prospective single-blinded study by analyzing bile samples from malignant biliary obstruction patients and control groups without any tumor in the biliary system or other organs to compare the specificity and sensitivity of the UCAD test for diagnosing malignant biliary obstruction to other modalities such as bile cytology The investigators also intend to investigate the potential of UCAD in malignant biliary obstruction patient follow-up by analyzing the CIN level and following malignant biliary obstruction patients for up to 2 years to determine if there is a correlation between CIN level and patient prognosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None