ctDNA Detection of MRD in Predicting Postoperative Recurr... | NCT05743959

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

NCT05743959

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Status

Unknown status

Last Update Posted

May 22, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Biliary Tract Cancer

Interventions

No intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Feb 15, 2023

First Submission Date that Met QC Criteria

Feb 15, 2023

First Posted Date

Feb 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2023

Last Update Posted Date

May 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Procedure	No intervention	Patients with stage I-III biliary tract cancers

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
Other conditions that researchers judged inappropriate for inclusion

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiangcheng Li, PhD	Contact	+8618951999088		drlixc@163.com
Xiaofeng Chen, PhD	Contact	+8613585172066		13585172066@126.com

Overall Officials

Name	Affiliation	Role
Xiangcheng Li, PhD	The First Affiliated Hospital with Nanjing Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital with NanJing Medical University	Recruiting	Nanjing	Jiangsu	210029	China

ID	Term
D001661	Biliary Tract Neoplasms
D018281	Cholangiocarcinoma
D018365	Neoplasm, Residual

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001660	Biliary Tract Diseases