ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma
NCT ID: NCT05479708
Last Updated: 2025-04-24
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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ENROLLING_BY_INVITATION
150 participants
OBSERVATIONAL
2023-08-09
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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ctDNA-based MRD detection
Postoperative circulating tumor DNA (ctDNA)-based minimal residual disease (MRD) detection for predicting relapse and survival benefit
Eligibility Criteria
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Inclusion Criteria
* KRAS mutations identified in resected tumor tissues
* Margin negative (R0) or no imaging recurrence/metastasis and CA 19-9\<37 U/ml in postoperative 4-8 weeks (before adjuvant chemotherapy)
* Receiving adjuvant chemotherapy
* ECOG 0-2
* Signed informed consent
Exclusion Criteria
* Distant organ metastasis or malignant ascites
* Receiving neo-adjuvant therapy before surgery
* Imaging recurrence/metastasis or CA 19-9\>37 U/ml in postoperative 4-8 weeks (before adjuvant chemotherapy)
* Pregnant or breastfeeding at time of enrollment
* Prior transplantation of bone marrow, stem cell or organ
18 Years
75 Years
ALL
No
Sponsors
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GeneCast Biotechnology Co., Ltd.
INDUSTRY
BAIYONG SHEN
OTHER
Responsible Party
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BAIYONG SHEN
Professor
Principal Investigators
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Baiyong Shen, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Locations
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Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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D-P220426-MRD-RJ-1
Identifier Type: -
Identifier Source: org_study_id
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