NCT07176962 A Cell-free DNA Methylation Blood-Based Test for Biliary Tract Cancers Screening
| NCT ID | NCT07176962 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yingbin Liu, MD, PhD, FACS |
| Condition | Gall Bladder Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,800 participants |
| Start Date | 2020-01-01 |
| Primary Completion | 2026-03-21 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,800 participants in total. It began in 2020-01-01 with a primary completion date of 2026-03-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria Internal Training and Validation Cohorts * BTC patients 1. 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). 2. Age 18-80 years (inclusive). 3. Able to provide required blood samples. 4. Pathologically confirmed biliary tract carcinoma (TNM stage I-IV). 5. Stable vital signs; ECOG performance status 0-1. 6. 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) 1. Voluntary participation with signed informed consent (or by LAR). 2. Age 18-80 years (inclusive). 3. Able to provide required blood samples. 4. Pathologically confirmed gastrointestinal malignancies other than BTC, including hepatocellular carcinoma, gastric cancer, colorectal cancer, and pancreatic cancer (TNM stage I-IV). 5. Stable vital signs; ECOG performance status 0-1. * Non-cancer participants (benign biliary disease) 1. Able to provide written informed consent. 2. Able to provide required blood samples. 3. Age 18-80 years (inclusive). 4. 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 1. Voluntary participation with signed informed consent (or by LAR). 2. 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. 3. Age 18-80 years (inclusive). 4. Able to provide required blood samples. 5. Stable vital signs; ECOG performance status 0-1. 6. 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 1. Able to provide written informed consent. 2. Able to provide required blood samples. 3. Age 18-80 years (inclusive). Exclusion Criteria Training and Validation Cohorts * Cancer patients 1. Pregnant or breastfeeding women. 2. History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation. 3. Blood transfusion within 7 days prior to blood collection. 4. History of curative cancer treatment within 3 years prior to blood collection. 5. Use of anti-tumor drugs within 30 days prior to blood collection. 6. Known bleeding disorders. 7. Known autoimmune diseases. 8. Concurrent other malignancies or multiple primary tumors. * Non-cancer participants 1. Pregnant or breastfeeding women. 2. History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation. 3. Blood transfusion within 7 days prior to blood collection. 4. History of any malignant tumor. 5. Known bleeding disorders. 6. Known autoimmune diseases. 7. Clinically significant abnormalities on routine examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules). External Validation Cohorts * Cancer patients 1. Pregnant or breastfeeding women. 2. History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation. 3. Blood transfusion within 7 days prior to blood collection. 4. History of or ongoing curative cancer treatment within 3 years prior to blood collection. 5. Use of anti-tumor drugs within 30 days prior to blood collection. 6. Known bleeding disorders or autoimmune diseases. 7. Concurrent other malignancies (including multiple primaries) or known cancer susceptibility gene carriers. 8. Pathology confirmed benign disease after biopsy/surgery. 9. Failure to confirm malignancy by pathology or imaging within 42 days after blood collection, or unclear lesion site/evidence. 10. 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 1. Pregnant or breastfeeding women. 2. History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation. 3. Blood transfusion within 7 days prior to blood collection. 4. History of any malignant tumor. 5. Known bleeding disorders or autoimmune diseases. 6. Clinically significant abnormalities on health examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).
Contact & Investigator
Yingbin Liu, PhD
PRINCIPAL INVESTIGATOR
RenJi Hospital
Frequently Asked Questions
Who can join the NCT07176962 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Gall Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07176962 currently recruiting?
Yes, NCT07176962 is actively recruiting participants. Contact the research team at laoniulyb@163.com for enrollment information.
Where is the NCT07176962 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07176962 clinical trial?
NCT07176962 is sponsored by Yingbin Liu, MD, PhD, FACS. The principal investigator is Yingbin Liu, PhD at RenJi Hospital. The trial plans to enroll 1,800 participants.
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