Using chromosomal instability to diagnose biliary tract cancer early
Application of Chromosomal Instability and Metagenomic Detection in Early Diagnosis of Biliary Tract Carcinoma in Bile
This study is testing a new method to see if analyzing DNA from bile samples can help doctors find biliary tract cancer earlier in patients who might have it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University Academic / other |
| Locations | 4 sites (Hangzhou, Zhejiang and 3 other locations) |
| Trial ID | NCT05845554 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a new method called BileCAD to analyze chromosomal instability (CIN) in DNA extracted from bile samples of patients suspected of having biliary tract carcinoma. By employing low-coverage whole-genome sequencing, the study aims to identify CIN, which is associated with poor prognosis and treatment resistance in cancer. The goal is to improve early diagnosis and monitoring of biliary tract carcinoma, which often presents with non-specific symptoms and is diagnosed at advanced stages. The study will include bile samples from patients with gallbladder cancers and cholangiocarcinoma, as well as control groups.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with suspected biliary tract carcinoma, such as those with gallstones or obstructive jaundice.
Not a fit: Patients under 18 years old or those with active autoimmune diseases or uncontrolled severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate diagnosis of biliary tract carcinoma, potentially improving patient outcomes.
How similar studies have performed: While the use of chromosomal instability as a diagnostic tool is established in cancer research, the specific application of BileCAD for biliary tract carcinoma is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang and 3 other locations
- Sir Run Run Shaw Hospital, School of Medicine，Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
- Taizhou First People's Hospital — Taizhou, Zhejiang, China (Recruiting)
- Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (Recruiting)
- First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: fabiao zhang — Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
- Study coordinator: fabiao zhang
- Email: zhangfabiao@enzemed.com
- Phone: 13706760105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.