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

NCT05743959 | Unknown

• 1 other identifier: Dominant_2022
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Biliary Tract Cancer

Keywords

Cholangiocarcinoma; ctDNA; Minimal Residual Disease (MRD)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with stage I-III biliary tract cancers

Patients with stage I-III biliary tract cancers eligible for curative surgical resection

Procedure: No intervention

Interventions

No intervention PROCEDURE

No intervention

Patients with stage I-III biliary tract cancers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Male or female ≥ 18 years of age on the day of signing informed consent.
• Clinically diagnosed as BTC before surgery and confirmed by pathology after surgery.
• 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.
• Patients must have a performance status of ≤1 on the ECOG Performance Scale.
• Patients must have survival of \> 6 months after surgery
• Serological tumor indicators (CEA, CA19-9) and imaging data ( CT and/or MRI, PET-CT) were complete.
• Blood biochemical indicators meet surgical standards
• 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.

You may not qualify if:

• Patients with recurrent biliary tract tumors
• Patients with hepatobiliary mixed tumors
• Patients with malignant tumors of other organs that have not been cured before.
• History of organ transplant or allogeneic stem cell transplant
• Patients with severe infections that are active or poorly controlled clinically
• patients who are cognitively impaired or with known psychiatric disorders, and/or substance abuse
• pregnant or lactating women
• Failed to sign informed consent

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with NanJing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms; Cholangiocarcinoma; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiangcheng Li, PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangcheng Li, PhD

CONTACT

+8618951999088; drlixc@163.com

Xiaofeng Chen, PhD

CONTACT

+8613585172066; 13585172066@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 24, 2023
• Study Start: May 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)