ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma

NCT ID: NCT05479708

Last Updated: 2025-04-24

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-09

Study Completion Date

2025-11-30

Brief Summary

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Short-term relapse and poor survival are prevalent in patients with pancreatic adenocarcinoma (PAAD) after surgeries. Despite the importance of adjuvant treatments for resected PAAD patients, there is currently no suitable biomarker to identify those individuals with high risk of recurrence and inform therapeutic decision making. In this study, we aim to examine whether postoperative circulating tumor DNA (ctDNA) could be used as a biomarker for early detection of minimal residual disease (MRD) and predicting relapse in resected PAAD through high-depth targeted next-generation sequencing.

Detailed Description

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Conditions

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Pancreatic Cancer Resectable

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pathologically diagnosed pancreatic adenocarcinoma (stage I-III)
* 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

* With serious internal medicine diseases, infectious diseases, other solid tumors (except PAAD) or hematologic disorders
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GeneCast Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role collaborator

BAIYONG SHEN

OTHER

Sponsor Role lead

Responsible Party

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BAIYONG SHEN

Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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China

Other Identifiers

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D-P220426-MRD-RJ-1

Identifier Type: -

Identifier Source: org_study_id

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