ctDNA Detection of MRD in Predicting Postoperative Recurrence in Biliary Tract Cancers：A Multicenter Prospective Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Biliary Tract Cancer
• Intervention / Treatment: Procedure: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Xiangcheng Li, PhD; Phone Number: +8618951999088; Email: drlixc@163.com
• Study Contact Backup: Name: Xiaofeng Chen, PhD; Phone Number: +8613585172066; Email: 13585172066@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • The First Affiliated Hospital with Nanjing Medical University
      • Contact: Xiangcheng Li, PhD; Phone Number: +8618951999088; Email: drlixc@163.com
      • Contact: Xiaofeng Chen, PhD; Phone Number: +8613585172066; Email: 13585172066@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with stage I-III biliary duct cancer eligible for curative surgical resection

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with stage I-III biliary tract cancers; Patients with stage I-III biliary tract cancers eligible for curative surgical resection	Procedure: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse-free survival	The primary endpoint for this study is Relapse-free survival (RFS), which will be assessed using RECIST version 1.1.	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Principal Investigator: Xiangcheng Li, PhD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Minimal Residual Disease (MRD); Cholangiocarcinoma; ctDNA
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Digestive System Neoplasms; Biliary Tract Diseases; Recurrence; Biliary Tract Neoplasms
• Other Study ID Numbers: Dominant_2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No