Skip to content

Study on the relations between CTC-NGS based on HSPG classification and stage and metastasis of biliary tract cancer

Study on the relations between next-generation sequencing of circulating tumor cell based on the classification of heparan sulfate proteoglycan, and stage and metastasis of biliary tract cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036577
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-11-01
Completion date
Unknown
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Cancer

Interventions

Gold Standard:Pathological and imaging diagnosis of advanced stage (TNM stage III/IV) and distant metastasis of biliary tract cancer
Index test:HSPG-based&#32
and&#32
score&#32
for&#32
of&#32
cancer

Sponsors

Third Affiliated Hospital, also called Shanghai Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with biliary tract cancer diagnosed by imaging and serology after multidisciplinary discussion, have completed clinical tumor staging and metastasis assessment, and are ready to undergo surgical resection, surgical biopsy, or puncture biopsy. There has been no surgery, radiotherapy, cheomtherapy, or other anti-tumor treatments in the past 3 months. 2. Age from 18 to 70 years old; 3. There are measurable or evaluable tumor lesions by CT or MRI (according to RECIST 1.1 standard); 4. KPS score is greater than 60; 5. Good blood function: hemoglobin =8g/dL, absolute neutrophil count =1.5×109/L, platelet count =100×109/L; 6. Good liver and kidney function reserve: Child-Pugh class A liver function, creatinine clearance rate> 60 ml/min; creatinine <120 µmol/L; 7. No heart failure, no uncontrollable chest pain; no myocardial infarction or cerebral infarction occurred in the 12 months before the start of the study; 8. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients suffering from other malignant tumors in the past; 2. Active infection period or other serious infections that may interfere with the test results of this project; 3. Patients with severe anemia or other organ insufficiency; 4. Pregnant or breastfeeding women; 5. Individuals undergoing correction monitoring or supervision; 6. Other conditions that may interfere with the test results of this item.

Design outcomes

Primary

MeasureTime frame
Area under the ROC curve;SEN, SPE, ACC;

Countries

China

Contacts

Public ContactYI Bin

The Third Affilliated Hospital, The Second Military Medical University

billyyi11@163.com+86 13916199606

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026