Status:
RECRUITING
A Prospective Study of Liquid Biopsy for Pancreatic Cancer Early Detection
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Shanghai Weihe Medical Laboratory Co., Ltd.
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
40-75 years
Brief Summary
This study is a multi-center, observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from clinically-annotated indi...
Detailed Description
Peripheral blood samples from participants with new diagnosis of pancreatic cancers will be collected to characterize the cancer-specific circulating signals by sequencing cell free DNA. A noninvasive...
Eligibility Criteria
Inclusion
- Cancer Arm
- 40-75 years old
- Clinically and/or pathologically diagnosed pancreatic cancer
- No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures.
Exclusion
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °C) within 14 days prior to blood draw
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 30 days prior to study blood draw
- Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide
- Other conditions that the investigators considered are not suitable for the enrollment
- Benign Disease Arm
- Inclusion Criteria:
- 40-75 years old
- Clinically and/or pathologically diagnosed pancreatic non-malignant disease (pancreatic intraepithelial neoplasia, pancreatic cyst and chronic pancreatitis)
- No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures
Key Trial Info
Start Date :
December 18 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT06166147
Start Date
December 18 2023
End Date
March 31 2027
Last Update
September 19 2024
Active Locations (3)
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1
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, China, 200032
2
Department of Hepato-Biliary-Pancreatic-Splenic Surgery, Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
3
Department of General Sugery, Huadong Hospital
Shanghai, Shanghai Municipality, China