Biliary Tract CancerNCT05743959
ctDNA Detection of MRD in Predicting Postoperative Recurrence in Biliary Tract Cancers：A Multicenter Prospective Trial
An observational study of Biliary Tract Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with stage I-III biliary duct cancer eligible for curative surgical resection
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- pregnant or lactating women
- Failed to sign informed consent
- Other conditions that researchers judged inappropriate for inclusion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with NanJing Medical University
Nanjing, Jiangsu, 210029
Xiangcheng Li, PhD, +8618951999088, drlixc@163.com
Xiaofeng Chen, PhD, +8613585172066, 13585172066@126.com
About this study
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
- Being tested
- No intervention
- Keywords
- Cholangiocarcinoma, ctDNA, Minimal Residual Disease (MRD)
- Medical subject headings
- Biliary Tract Neoplasms, Cholangiocarcinoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionProcedure or surgery
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with stage I-III biliary tract cancers | Patients with stage I-III biliary tract cancers eligible for curative surgical resection Receives: Procedure: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival
The primary endpoint for this study is Relapse-free survival (RFS), which will be assessed using RECIST version 1.1.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 May 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangcheng Li, PhD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743959
- Sponsor's protocol ID
- Dominant_2022
- Status last verified
- May 2023
- First submitted
- 15 Feb 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ctDNA Detection of MRD in Predicting Postoperative Recurrence in Biliary Tract Cancers：A Multicenter Prospective Trial
- ClinicalTrials.gov ID
- NCT05743959
- Acronym / sponsor ID
- Dominant_2022
- Conditions
- Biliary Tract Cancer
- Keywords
- Cholangiocarcinoma, ctDNA, Minimal Residual Disease (MRD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with stage I-III biliary tract cancers | – | Procedure: No interventionPatients with stage I-III biliary tract cancers eligible for curative surgical resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with stage I-III biliary duct cancer eligible for curative surgical resection
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Procedure or surgery | Patients with stage I-III biliary tract cancers |
Primary outcome
Relapse-free survival
Time frame: through study completion, an average of 2 years
The primary endpoint for this study is Relapse-free survival (RFS), which will be assessed using RECIST version 1.1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangcheng Li, PhD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangcheng Li, PhD (+8618951999088, drlixc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.