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Trial Title:
ctDNA Detection of MRD in Predicting Postoperative Recurrence in Biliary Tract Cancers：A Multicenter Prospective Trial
NCT ID:
NCT05743959
Condition:
Biliary Tract Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Recurrence
Conditions: Keywords:
Cholangiocarcinoma
ctDNA
Minimal Residual Disease (MRD)
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
No intervention
Description:
No intervention
Arm group label:
Patients with stage I-III biliary tract cancers
Summary:
A substantial proporation of patients with biliary tract malignancies still experience
disease recurrence after curative resection. ctDNA-based minimal residual disease (MRD)
method has been widely used to monitor postoperative recurrence in solid cancers, but few
studies have been reported in biliary tract cancers.
The present clinical trial aims to elucidate the correlation between the postoperative
ctDNA status and the prognosis of patients with biliary tract cancers, and evaluate
whether ctDNA could better predict patients' recurrence and guide clinical practice.
Criteria for eligibility:
Study pop:
Patients with stage I-III biliary duct cancer eligible for curative surgical resection
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Male or female ≥ 18 years of age on the day of signing informed consent.
2. Clinically diagnosed as BTC before surgery and confirmed by pathology after surgery.
3. Stage I-III tumor according to the UICC/AJCC TNM staging system (8th edition in
2017), meeting the indications for radical surgery and are planned to undergo
radical treatment. Those who do not undergo radical surgery will be excluded.
4. Patients must have a performance status of ≤1 on the ECOG Performance Scale.
5. Patients must have survival of > 6 months after surgery
6. Serological tumor indicators (CEA, CA19-9) and imaging data ( CT and/or MRI, PET-CT)
were complete.
7. Blood biochemical indicators meet surgical standards
8. Written informed consent must be obtained from patient or patient's legal
representative and ability for patient to comply with the requirements of the study.
Exclusion Criteria:
1. Patients with recurrent biliary tract tumors
2. Patients with hepatobiliary mixed tumors
3. Patients with malignant tumors of other organs that have not been cured before.
4. History of organ transplant or allogeneic stem cell transplant
5. Patients with severe infections that are active or poorly controlled clinically
6. patients who are cognitively impaired or with known psychiatric disorders, and/or
substance abuse
7. pregnant or lactating women
8. Failed to sign informed consent
9. Other conditions that researchers judged inappropriate for inclusion
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
The First Affiliated Hospital with NanJing Medical University
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiangcheng Li, PhD
Phone:
+8618951999088
Email:
drlixc@163.com
Contact backup:
Last name:
Xiaofeng Chen, PhD
Phone:
+8613585172066
Email:
13585172066@126.com
Start date:
May 1, 2022
Completion date:
December 30, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05743959
