Gall Bladder CancerNCT07176962
A Cell-free DNA Methylation Blood-Based Test for Biliary Tract Cancers Screening
An observational study of Gall Bladder Cancer and Intrahepatic Cholangiocarcinoma (Icc), run by Yingbin Liu, MD, PhD, FACS at 1 site in China.
Trial summary
Biliary tract carcinoma (BTC), including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma, ranks sixth in incidence among gastrointestinal malignancies and tenth in cancer-related mortality worldwide. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gall Bladder Cancer, Intrahepatic Cholangiocarcinoma (Icc), Extrahepatic Cholangiocarcinoma
- How many people
- 1,800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population comprises individuals meeting inclusion criteria and not meeting any exclusion criteria.
Who may be able to join
- BTC patients
- Willing to voluntarily participate and able to comply with study procedures; if unable to read or sign, informed consent must be signed by a legally authorized representative (LAR).
- Age 18-80 years (inclusive).
- Able to provide required blood samples.
- Pathologically confirmed biliary tract carcinoma (TNM stage I-IV).
- Stable vital signs; ECOG performance status 0-1.
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- Adequate organ function: AST/ALT ≤ 5 × ULN; Child-Pugh class A or B; WBC > 3 × 10⁹/L; ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 75 × 10⁹/L; Hemoglobin ≥ 90 g/L; Creatinine clearance ≥ 60 mL/min; Total bilirubin ≤ 3 × ULN.
- Other gastrointestinal malignancies (to exclude BTC non-specific signals)
- Voluntary participation with signed informed consent (or by LAR).
- Age 18-80 years (inclusive).
- Able to provide required blood samples.
- Pathologically confirmed gastrointestinal malignancies other than BTC, including hepatocellular carcinoma, gastric cancer, colorectal cancer, and pancreatic cancer (TNM stage I-IV).
- Stable vital signs; ECOG performance status 0-1.
- Non-cancer participants (benign biliary disease)
- Able to provide written informed consent.
- Able to provide required blood samples.
- Age 18-80 years (inclusive).
- Pathologically or clinically diagnosed benign biliary diseases, including cholecystitis, cholelithiasis, choledocholithiasis, adenomyomatosis, gallbladder polyps, xanthogranulomatous cholecystitis, or primary sclerosing cholangitis.
- External Validation Cohorts
- BTC patients
- Voluntary participation with signed informed consent (or by LAR).
- Imaging findings of malignant biliary stricture or mass, or serum CA19-9 > 100 U/mL, highly suspicious for BTC, with planned surgery or biopsy for pathological confirmation.
- Age 18-80 years (inclusive).
- Able to provide required blood samples.
- Stable vital signs; ECOG performance status 0-1.
- Adequate organ function: AST/ALT ≤ 5 × ULN; Child-Pugh class A or B; WBC > 3 × 10⁹/L; ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 75 × 10⁹/L; Hemoglobin ≥ 90 g/L; Creatinine clearance ≥ 60 mL/min; Total bilirubin ≤ 3 × ULN.
- Healthy volunteers
- Able to provide written informed consent.
- Able to provide required blood samples.
- Age 18-80 years (inclusive).
Who cannot join
- Cancer patients
- Pregnant or breastfeeding women.
- History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation.
- Blood transfusion within 7 days prior to blood collection.
- History of curative cancer treatment within 3 years prior to blood collection.
- Use of anti-tumor drugs within 30 days prior to blood collection.
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- Known bleeding disorders.
- Known autoimmune diseases.
- Concurrent other malignancies or multiple primary tumors.
- Non-cancer participants
- Pregnant or breastfeeding women.
- History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation.
- Blood transfusion within 7 days prior to blood collection.
- History of any malignant tumor.
- Known bleeding disorders.
- Known autoimmune diseases.
- Clinically significant abnormalities on routine examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).
- External Validation Cohorts
- Cancer patients
- Pregnant or breastfeeding women.
- History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation.
- Blood transfusion within 7 days prior to blood collection.
- History of or ongoing curative cancer treatment within 3 years prior to blood collection.
- Use of anti-tumor drugs within 30 days prior to blood collection.
- Known bleeding disorders or autoimmune diseases.
- Concurrent other malignancies (including multiple primaries) or known cancer susceptibility gene carriers.
- Pathology confirmed benign disease after biopsy/surgery.
- Failure to confirm malignancy by pathology or imaging within 42 days after blood collection, or unclear lesion site/evidence.
- Special exclusion criteria:
- Pathology confirmed precancerous lesions.
- Any local/regional or systemic anti-tumor therapy (including surgery, radiotherapy, targeted therapy, or immunotherapy) prior to blood collection.
- Healthy volunteers
- Pregnant or breastfeeding women.
- History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation.
- Blood transfusion within 7 days prior to blood collection.
- History of any malignant tumor.
- Known bleeding disorders or autoimmune diseases.
- Clinically significant abnormalities on health examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai
Shanghai, Shanghai Municipality, 200127
Yingbin Liu, PhD, +86 13918803900, laoniulyb@163.com
About this study
Official title: A Cell-free DNA Methylation Liquid Biopsy for Diagnosis and Management of Biliary Tract Cancers
Biliary tract carcinoma (BTC), including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma, ranks sixth in incidence among gastrointestinal malignancies and tenth in cancer-related mortality worldwide. Due to the lack of specific early symptoms, high malignancy, and frequent recurrence and metastasis, the rate of curative resection is only about 16.5%, and the overall 5-year survival rate is less than 5%. Early and accurate detection is therefore critical for improving patient outcomes. Circulating tumor DNA (ctDNA), a fraction of circulating free DNA (cfDNA), carries genetic and epigenetic information from tumor cells and can be detected even at the early stages of cancer development. Among various liquid biopsy biomarkers, ctDNA methylation shows particular advantages in sensitivity and specificity for early cancer detection and monitoring. This study aims to evaluate the application of cfDNA methylation liquid biopsy in the diagnosis and management of BTC.
Read the detailed description
Biliary tract carcinoma (BTC), encompassing gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma, is an aggressive malignancy with poor prognosis. Globally, it ranks sixth in incidence among gastrointestinal cancers and tenth in cancer-related mortality. BTC is characterized by the absence of specific early symptoms, high degree of malignancy, and a strong tendency for recurrence and metastasis. The curative resection rate remains around 16.5%, and the overall 5-year survival rate is less than 5%.
Biliary tract inflammation (such as cholangitis, acute cholecystitis, sclerosing cholangitis, and autoimmune cholangitis) can lead to abnormal CA19-9 elevation. In addition, IgG4-related sclerosing cholangitis often affects elderly patients and may mimic hilar cholangiocarcinoma, creating diagnostic challenges. Imaging alone often lacks accuracy in differentiating benign from malignant biliary lesions, resulting in misdiagnosis and inappropriate clinical decision-making. The number of patients with incidentally detected BTC during surgery is rapidly increasing, and reoperations impose substantial trauma and socioeconomic burden.
Circulating tumor DNA (ctDNA) refers to DNA fragments released into the bloodstream from tumor cells through apoptosis, necrosis, or secretion. ctDNA carries genomic alterations (point mutations, indels, CNVs, fusions), epigenetic modifications (DNA methylation [5mC], hydroxymethylation [5hmC]), and structural features (fragment length, fragmentation patterns). Circulating free DNA (cfDNA) represents the total extracellular DNA in plasma or serum, of which ctDNA accounts for less than 1%. Accumulating evidence shows that ctDNA is detectable in the early stages of tumorigenesis, highlighting its clinical potential in early detection, diagnosis, treatment guidance, and post-treatment monitoring.
The choice of biomarker type is key to liquid biopsy applications, and ctDNA methylation offers distinct advantages. Liquid biopsy analytes include circulating tumor cells (CTCs), ctDNA, exosomes, and microRNAs (miRNAs), each with unique detection characteristics. ctDNA, directly derived from tumor cells, provides relatively high sensitivity for early detection and is currently the most widely used target in clinical practice. Research on ctDNA has focused mainly on methylation, somatic mutations, and copy number variations. Among these, ctDNA methylation balances both signal abundance and signal strength, offering clear advantages over other approaches. Methylation analysis methods include restriction enzyme digestion, affinity enrichment, and bisulfite conversion. Among them, bisulfite-based approaches are the most established and widely used.
Therefore, the application of cfDNA methylation liquid biopsy in BTC for early screening, differential diagnosis, prognostic monitoring, and therapeutic guidance holds great significance for improving diagnosis, treatment, and patient outcomes.
- Conditions
- Gall Bladder Cancer, Intrahepatic Cholangiocarcinoma (Icc), Extrahepatic Cholangiocarcinoma, Hilar Cholangiocarcinoma, Billiary Track Cancer, ctDNA
- Keywords
- ctDNA methylation, Early diagnosis, Liquid biopsy, Billiary Track Cancer
- Medical subject headings
- Gallbladder Neoplasms, Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension, Klatskin Tumor, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control（Internal training and validation sets） | Healthy individuals Patients with pathologically confirmed benign biliary lesions Patients with other gastrointestinal malignancies | |
| malignant（Internal training and validation sets） | patients with intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer | |
| malignant (Independent validation set) | patients with suspected biliary tract malignancies | |
| control (Independent validation set) | Healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of the ctDNA methylation model in biliary tract cancer
Evaluate the overall sensitivity, specificity, and accuracy of the ctDNA methylation liquid biopsy model in the diagnosis of biliary tract cancer (BTC).
Measured: Baseline
Secondary outcomes (3)
Subtype-specific diagnostic performance
Sensitivity, specificity, and accuracy of the ctDNA methylation model in gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma.
Measured: Baseline
Stage-specific diagnostic performance
Sensitivity, specificity, and accuracy of the model across BTC stages I-IV (TNM staging).
Measured: Baseline
Differential diagnosis
Sensitivity, specificity, and accuracy of the ctDNA methylation model in distinguishing BTC from benign biliary lesions.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Jan 2020
- Primary completion21 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gall Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yingbin Liu, MD, PhD, FACS
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Xijing Hospital, First Affiliated Hospital Xi'an Jiaotong University, West China Hospital, Sun Yat-Sen University Cancer Center, Hunan Provincial People's Hospital, Fudan University
- Responsible party
- Sponsor-investigator, Yingbin Liu, MD, PhD, FACS, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yingbin Liu, PhD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176962
- Sponsor's protocol ID
- BTC_ctDNAm_LYB_2025
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chung DC, Gray DM 2nd, Singh H, Issaka RB, Raymond VM, Eagle C, Hu S, Chudova DI, Talasaz A, Greenson JK, Sinicrope FA, Gupta S, Grady WM. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):973-983. doi: 10.1056/NEJMoa2304714.
PubMed 38477985Nagino M, Hirano S, Yoshitomi H, Aoki T, Uesaka K, Unno M, Ebata T, Konishi M, Sano K, Shimada K, Shimizu H, Higuchi R, Wakai T, Isayama H, Okusaka T, Tsuyuguchi T, Hirooka Y, Furuse J, Maguchi H, Suzuki K, Yamazaki H, Kijima H, Yanagisawa A, Yoshida M, Yokoyama Y, Mizuno T, Endo I. Clinical practice guidelines for the management of biliary tract cancers 2019: The 3rd English edition. J Hepatobiliary Pancreat Sci. 2021 Jan;28(1):26-54. doi: 10.1002/jhbp.870. Epub 2020 Dec 23.
PubMed 33259690Yang M, Zhao Y, Li C, Weng X, Li Z, Guo W, Jia W, Feng F, Hu J, Sun H, Wang B, Li H, Li M, Wang T, Zhang W, Jiang X, Zhang Z, Liu F, Hu H, Wu X, Gu J, Yang G, Li G, Zhang H, Zhang T, Zang H, Zhou Y, He M, Yang L, Wang H, Chen T, Zhang J, Chen W, Wu W, Li M, Gong W, Lin X, Liu F, Liu Y, Liu Y. Multimodal integration of liquid biopsy and radiology for the noninvasive diagnosis of gallbladder cancer and benign disorders. Cancer Cell. 2025 Mar 10;43(3):398-412.e4. doi: 10.1016/j.ccell.2025.02.011.
PubMed 40068597Vogel A, Bridgewater J, Edeline J, Kelley RK, Klumpen HJ, Malka D, Primrose JN, Rimassa L, Stenzinger A, Valle JW, Ducreux M; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Feb;34(2):127-140. doi: 10.1016/j.annonc.2022.10.506. Epub 2022 Nov 10. No abstract available.
PubMed 36372281
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cell-free DNA Methylation Liquid Biopsy for Diagnosis and Management of Biliary Tract Cancers
- ClinicalTrials.gov ID
- NCT07176962
- Acronym / sponsor ID
- BTC_ctDNAm_LYB_2025
- Conditions
- Gall Bladder Cancer, Intrahepatic Cholangiocarcinoma (Icc), Extrahepatic Cholangiocarcinoma, Hilar Cholangiocarcinoma, Billiary Track Cancer, ctDNA
- Keywords
- ctDNA methylation, Early diagnosis, Liquid biopsy, Billiary Track Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Yingbin Liu, MD, PhD, FACSUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Xijing Hospital, First Affiliated Hospital Xi'an Jiaotong University, West China Hospital, Sun Yat-Sen University Cancer Center, Hunan Provincial People's Hospital, Fudan University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 21 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Biliary tract carcinoma (BTC), including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma, ranks sixth in incidence among gastrointestinal malignancies and tenth in cancer-related mortality worldwide. Due to the lack of specific early symptoms, high malignancy, and frequent recurrence and metastasis, the rate of curative resection is only about 16.5%, and the overall 5-year survival rate is less than 5%. Early and accurate detection is therefore critical for improving patient outcomes. Circulating tumor DNA (ctDNA), a fraction of circulating free DNA (cfDNA), carries genetic and epigenetic information from tumor cells and can be detected even at the early stages of cancer development. Among various liquid biopsy biomarkers, ctDNA methylation shows particular advantages in sensitivity and specificity for early cancer detection and monitoring. This study aims to evaluate the application of cfDNA methylation liquid biopsy in the diagnosis and management of BTC.
Detailed description
Biliary tract carcinoma (BTC), encompassing gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma, is an aggressive malignancy with poor prognosis. Globally, it ranks sixth in incidence among gastrointestinal cancers and tenth in cancer-related mortality. BTC is characterized by the absence of specific early symptoms, high degree of malignancy, and a strong tendency for recurrence and metastasis. The curative resection rate remains around 16.5%, and the overall 5-year survival rate is less than 5%.
Biliary tract inflammation (such as cholangitis, acute cholecystitis, sclerosing cholangitis, and autoimmune cholangitis) can lead to abnormal CA19-9 elevation. In addition, IgG4-related sclerosing cholangitis often affects elderly patients and may mimic hilar cholangiocarcinoma, creating diagnostic challenges. Imaging alone often lacks accuracy in differentiating benign from malignant biliary lesions, resulting in misdiagnosis and inappropriate clinical decision-making. The number of patients with incidentally detected BTC during surgery is rapidly increasing, and reoperations impose substantial trauma and socioeconomic burden.
Circulating tumor DNA (ctDNA) refers to DNA fragments released into the bloodstream from tumor cells through apoptosis, necrosis, or secretion. ctDNA carries genomic alterations (point mutations, indels, CNVs, fusions), epigenetic modifications (DNA methylation [5mC], hydroxymethylation [5hmC]), and structural features (fragment length, fragmentation patterns). Circulating free DNA (cfDNA) represents the total extracellular DNA in plasma or serum, of which ctDNA accounts for less than 1%. Accumulating evidence shows that ctDNA is detectable in the early stages of tumorigenesis, highlighting its clinical potential in early detection, diagnosis, treatment guidance, and post-treatment monitoring.
The choice of biomarker type is key to liquid biopsy applications, and ctDNA methylation offers distinct advantages. Liquid biopsy analytes include circulating tumor cells (CTCs), ctDNA, exosomes, and microRNAs (miRNAs), each with unique detection characteristics. ctDNA, directly derived from tumor cells, provides relatively high sensitivity for early detection and is currently the most widely used target in clinical practice. Research on ctDNA has focused mainly on methylation, somatic mutations, and copy number variations. Among these, ctDNA methylation balances both signal abundance and signal strength, offering clear advantages over other approaches. Methylation analysis methods include restriction enzyme digestion, affinity enrichment, and bisulfite conversion. Among them, bisulfite-based approaches are the most established and widely used.
Therefore, the application of cfDNA methylation liquid biopsy in BTC for early screening, differential diagnosis, prognostic monitoring, and therapeutic guidance holds great significance for improving diagnosis, treatment, and patient outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control（Internal training and validation sets） | – | –Healthy individuals Patients with pathologically confirmed benign biliary lesions Patients with other gastrointestinal malignancies |
| malignant（Internal training and validation sets） | – | –patients with intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer |
| malignant (Independent validation set) | – | –patients with suspected biliary tract malignancies |
| control (Independent validation set) | – | –Healthy individuals |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises individuals meeting inclusion criteria and not meeting any exclusion criteria.
Key inclusion criteria (30 listed)
- BTC patients
- Other gastrointestinal malignancies (to exclude BTC non-specific signals)
- Non-cancer participants (benign biliary disease)
- External Validation Cohorts
- BTC patients
Key exclusion criteria (38 listed)
- Cancer patients
- Non-cancer participants
- External Validation Cohorts
- Cancer patients
- Pathology confirmed precancerous lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of the ctDNA methylation model in biliary tract cancer
Time frame: Baseline
Evaluate the overall sensitivity, specificity, and accuracy of the ctDNA methylation liquid biopsy model in the diagnosis of biliary tract cancer (BTC).
3 secondary outcomes
Subtype-specific diagnostic performance
Time frame: Baseline
Stage-specific diagnostic performance
Time frame: Baseline
Differential diagnosis
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Results publication: PubMed 38477985Chung DC, Gray DM 2nd, Singh H, Issaka RB, Raymond VM, Eagle C, Hu S, Chudova DI, Talasaz A, Greenson JK, Sinicrope FA, Gupta S, Grady WM. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):973-983. doi: 10.1056/NEJMoa2304714.
- Results publication: PubMed 33259690Nagino M, Hirano S, Yoshitomi H, Aoki T, Uesaka K, Unno M, Ebata T, Konishi M, Sano K, Shimada K, Shimizu H, Higuchi R, Wakai T, Isayama H, Okusaka T, Tsuyuguchi T, Hirooka Y, Furuse J, Maguchi H, Suzuki K, Yamazaki H, Kijima H, Yanagisawa A, Yoshida M, Yokoyama Y, Mizuno T, Endo I. Clinical practice guidelines for the management of biliary tract cancers 2019: The 3rd English edition. J Hepatobiliary Pancreat Sci. 2021 Jan;28(1):26-54. doi: 10.1002/jhbp.870. Epub 2020 Dec 23.
- Results publication: PubMed 40068597Yang M, Zhao Y, Li C, Weng X, Li Z, Guo W, Jia W, Feng F, Hu J, Sun H, Wang B, Li H, Li M, Wang T, Zhang W, Jiang X, Zhang Z, Liu F, Hu H, Wu X, Gu J, Yang G, Li G, Zhang H, Zhang T, Zang H, Zhou Y, He M, Yang L, Wang H, Chen T, Zhang J, Chen W, Wu W, Li M, Gong W, Lin X, Liu F, Liu Y, Liu Y. Multimodal integration of liquid biopsy and radiology for the noninvasive diagnosis of gallbladder cancer and benign disorders. Cancer Cell. 2025 Mar 10;43(3):398-412.e4. doi: 10.1016/j.ccell.2025.02.011.
- Results publication: PubMed 36372281Vogel A, Bridgewater J, Edeline J, Kelley RK, Klumpen HJ, Malka D, Primrose JN, Rimassa L, Stenzinger A, Valle JW, Ducreux M; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Feb;34(2):127-140. doi: 10.1016/j.annonc.2022.10.506. Epub 2022 Nov 10. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yingbin Liu, PhD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gall Bladder Cancer and Intrahepatic Cholangiocarcinoma (Icc), run by Yingbin Liu, MD, PhD, FACS at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yingbin Liu, PhD (+86 13918803900, laoniulyb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of the ctDNA methylation model in biliary tract cancer (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07176962, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.