NCT06166147Not yet recruitingNot Applicable
A Proof of Concept Study of Pancreatic Cancer Early Detection by cfDNA Assay
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Fudan University
- Enrollment
- 276
- Locations
- 3
- Primary Endpoint
- Performance of cfDNA methylation-based model for discriminating pancreatic cancer versus non-cancer
Study Overview
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 individuals.
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 test integrating machine learning algorithm will be trained and validated through a two-stage approach in recruited well-classified individuals, along with non-cancers without clinical diagnosis of cancer after routine medical screening. The performance of liquid biospy assays discovering cancer from non-cancer will be evaluated in participants with benign disease as well as average risk individuals.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
- •Exclusion Criteria:
- •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
Outcomes
Primary Outcomes
Performance of cfDNA methylation-based model for discriminating pancreatic cancer versus non-cancer
Time Frame: 12 months
Sensitivities of cfDNA methylation-based model at specificity of 99% and 95%, respectively.
Secondary Outcomes
- Performance of models using multi-omic data for discriminating pancreatic cancer versus non-cancer(12 months)
- Performance of pre-defined model in clinical sub-groups of interest(12 months)
Investigators
Xian-Jun Yu
Principal Investigator
Fudan University
Study Sites (3)
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