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Trial Title:
Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE)
NCT ID:
NCT06277531
Condition:
Biliary Stricture
Bile Duct Cancer
Pancreas Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Cholestasis
Constriction, Pathologic
Conditions: Keywords:
Malignant Biliary Stricture
Cell-Free Extrachromosomal Circular DNA (eccDNA)
Liquid-Biopsies Assay
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Biliary stricture is mainly malignant in the adults and caused by several types of fatal
malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which
have poor prognosis that the overall survival of unresectable lesions is no more than 15
months. The poor outcome often relates to a lack of reliable strategies for early
diagnosis, which results in most patients with malignant biliary stricture being already
advanced-stage disease at presentation. Therefore, it is critical to discover novel and
effective strategies for the early diagnosis of malignant biliary strictures.
Brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP)
are the main methods for recognizing malignant diseases of the bile duct, but their
sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other
biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than
80%.
In the previous study, the investigators found that bcf-eccDNA has excellent diagnostic
value in predicting uncertain bile duct stricture, and the sensitivity and specificity of
a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of
another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still
relatively small, and further prospective studies are needed to evaluate its diagnostic
efficacy.
Criteria for eligibility:
Study pop:
Patients are suspected indetermined biliary strictures
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients is suspected indetermined biliary strictures
- Patients have the indication for ERCP
Exclusion Criteria:
- ERCP failed, or can not obtain bile
- Sever comorbidities
- Predicted overall survival less than 1 year because of other disease
- Patients who are unlikely to comply with the protocol, inability to return for
subsequent visits
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Locations:
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
1000191
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhuo Cheng, M.D.
Phone:
+86-18701012781
Email:
chengzhuo321@pku.edu.cn
Facility:
Name:
Beijing Tsinghua Changgung Hospital
Address:
City:
Beijing
Zip:
102218
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiue Yan, M.D.
Phone:
+86-15811117418
Email:
pskyq@163.com
Start date:
March 1, 2024
Completion date:
March 1, 2027
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Collaborator:
Agency:
Beijing Tsinghua Changgeng Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06277531
