ctDNA Detection of MRD in Predicting Postoperative Recurrence in Biliary Tract Cancers：A Multicenter Prospective Trial
NCT ID: NCT05743959
Last Updated: 2023-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2022-05-01
2025-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with stage I-III biliary tract cancers
Patients with stage I-III biliary tract cancers eligible for curative surgical resection
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Principal Investigators
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Xiangcheng Li, PhD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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The First Affiliated Hospital with NanJing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Dominant_2022
Identifier Type: -
Identifier Source: org_study_id
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