Active — Not RecruitingNot Applicable

UCAD for Diagnosing Benign or Malignant Gallbladder Diseases and Follow-up

China1 participantsStarted 2024-01-01

Plain-language summary

Copy number variation(CNV) refers to ongoing chromosome segregation errors throughout consecutive cell divisions. CNV is a hallmark of human cancer, and it is associated with poor prognosis, metastasis, and therapeutic resistance. Analyzing CNV of the DNA extracted from bile samples in gallbladder seems a promising method for diagnosing, monitoring, and predicting the prognosis of patients with gallbladder cancer. CNV 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 CNV thus helping diagnose gallbladder cancer 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 gallbladder disease and planned to undergo surgery. * Male or female patients aged \>= 18 years. * Participants signed informed consent form. Exclusion Criteria: * Participants had other tumor expect gallbladder cancer

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

UCAD can be used as a diagnostic technology for gallbladder cancer with the sensitivity more than 90%

Timeframe: 2025

Trial details

NCT IDNCT06232538

SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01

View on ClinicalTrials.gov More Gallbladder Cancer trials