An observational study in Gallbladder Cancer, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-01.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Observational
Among 62 studies in Gallbladder Neoplasms with a site in China — 25 open to participants now, 28 under way, 4 of them phase 3. Gallbladder Neoplasms · China.
Among the 62 studies in Gallbladder Neoplasms with a site in China, this one is the 12th largest by enrollment of the 12 observational ones, is one of 10 that started in 2024, is one of 12 observational ones, reaches primary completion later than 6 of the 27 other live ones, and was the 41st registered.
301 studies on the registry are indexed under Gallbladder Neoplasms; 65 are open to participants now.
This study's enrollment of 1 is below the median of 200 across 61 observational studies indexed under Gallbladder Neoplasms.
Browse Gallbladder Neoplasms studies →25 of the 62 studies in Gallbladder Neoplasms with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 43 Gallbladder Neoplasms studies recruiting now, 24 (56%) set no upper age limit and 8 (19%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →62 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 10 started in 2024.
Median enrollment 91 across the 50 interventional studies, 330 across the 12 observational. Of the 15 that completed or were terminated, 6 (40%) have results posted.
14 of 62 have an industry lead sponsor. The 10 most frequent:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine has 4 studies filed under Gallbladder Neoplasms — fewer than ten, so there is no comparison to draw.
7 of the studies in Gallbladder Neoplasms with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06717464Tianjin Medical University Cancer Institute and HospitalToripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer | 2026-12-31 |
| NCT07025174First Affiliated Hospital of Zhejiang UniversitySequential Anti-Angiogenic Therapy After Immunotherapy in Advanced Biliary Tract Cancer | 2026-12-31 |
| NCT07007832Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineBile Omics for Diagnosing Indeterminate Biliary Strictures | 2026-12-31 |
| NCT07641036Beijing BiotechDual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer | 2027-03-14 |
| NCT07310069Xinhua Hospital, Shanghai Jiao Tong University School of MedicineGemcitabine and Nab-Paclitaxel Combined With Iparomlimab and Tuvorilimab for Advanced Gallbladder Cancer | 2027-05-01 |
Among the 62 studies in Gallbladder Neoplasms with a site in China, from their registry updates:
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.
Patients diagnosed with malignant biliary obstruction or participants in control group from February 2022 till the end of this study in 11 hospitals including Xinhua Hospital, Shanghai Zhongshan Hospital, Ruijin Hospital, Changhai Hospital, Shanghai Changzheng Hospital, Eastern Hepatobiliary Surgery Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, Jiangsu Provincial Hospital, The Third Affiliated Hospital of Sun Yat-Sen University, Tianjin Medical University Second Hospital, First Affiliated Hospital of Zhejiang University
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: The level of CNV
Diagnostic Test: The level of CNV
The extracted DNA from bile will be analyzed by UCAD to determine the level of CNV. And the patient will be followed more than 1 year.
UCAD can be used as a diagnostic technology for gallbladder cancer with the sensitivity more than 90%
Ultrasensitive chromosomal aneuploidy detection (UCAD) uses low-coverage whole-genome sequencing technology to detect DNA chromosomal instability in samples. By detecting DNA extracted from patients' bile and blood, bioinformatics can be used to analyze the differences in CNV between benign and malignant gallbladder diseases, and a prediction model for gallbladder cancer.
Time frame: 2025
Plan to share: No
Started Jan 2024 (actual). Primary completion is estimated for Jan 2026, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine →