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

Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743959
• Other study ID #: Dominant_2022
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Xiangcheng Li, PhD
• Phone: +8618951999088
• Email: drlixc[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Recurrence

Intervention

Procedure:
• No intervention
No intervention

Locations

Country	Name	City	State
China	The First Affiliated Hospital with NanJing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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