Application of Chromosomal Instability in Early Diagnosis of Biliary Tract Carcinoma (NCT05845554) | Clinical Trial Compass
UnknownNot Applicable
Application of Chromosomal Instability in Early Diagnosis of Biliary Tract Carcinoma
China300 participantsStarted 2023-03-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of bile sample analysis by BileCADanalysis
Timeframe: 12 months
2
Specificity of bile sample analysis by BileCADanalysis
Timeframe: 12 months
Trial details
NCT IDNCT05845554
SponsorTaizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University