A Prospective Study of UCAD for Diagnosing Benign or Malignant Biliary Obstruction and Follow-up (NCT05237193) | Clinical Trial Compass
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A Prospective Study of UCAD for Diagnosing Benign or Malignant Biliary Obstruction and Follow-up
China400 participantsStarted 2021-09-03
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 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.
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:
* Patients diagnosed with malignant biliary obstruction and planned to undergo ERCP(endoscopic retrograde cholangiopancreatography), PTCS(percutaneous transhepatic cholangioscopy) or surgery.
* Malignant biliary obstruction patients confirmed by operation or biopsy.
* Participants without any tumor disease and willing to attend the study.
* Male or female patients aged \>= 18 years.
* Participants signed informed consent form.
Exclusion Criteria:
* Patients diagnosed with malignant biliary obstruction and planned to undergo ERCP, PTCS or surgery.
* Malignant biliary obstruction patients confirmed by operation or biopsy.
* Participants without any tumor disease and willing to attend the study.
* Male or female patients aged \>= 18 years.
* Participants signed informed consent form.
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.
1This study is using something called UCAD to tell apart benign from malignant biliary obstruction — can you explain what UCAD is, how it would be used in my specific situation, and whether it would replace or just add to the standard tests I'd already be having?
2Since the trial is listed as 'Phase NA' and seems focused on measuring how accurate UCAD is rather than testing a treatment, does participating mean my actual treatment plan stays the same, or could there be any impact on the care I receive?
3The study also tracks patients with malignant biliary obstruction over time as a follow-up tool — given my diagnosis, do you think the follow-up monitoring approach in this trial would fit my situation, or is there a standard surveillance plan you'd recommend instead?
4The recruitment status for this trial is listed as unknown — is this study actually still enrolling patients at your institution, and if not, are there similar diagnostic studies nearby that might be worth exploring?
5If UCAD turns out to be less accurate in my specific case — for example, given the type of biliary condition I have — what are the backup diagnostic methods you'd rely on to make sure nothing is missed?
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 and Specificity of UCAD analysis
Timeframe: through study completion, an average of 30 months
2
Assess the value of UCAD for malignant biliary obstruction patient follow-up
Timeframe: through study completion, an average of 30 months
Trial details
NCT IDNCT05237193
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine