Clinical trial NCT06166147: A Prospective Study of Liquid Biopsy for Pancreatic Cancer Early Detection
Official title: A Proof of Concept Study of Pancreatic Cancer Early Detection by cfDNA Assay
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Weihe Medical Laboratory Co., Ltd.
First posted: 2023-12-12
Enrollment: 276
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed pancreatic cancer or pancreatic non-malignant disease

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.

Eligibility criteria: Cancer Arm

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

Primary outcomes:
measure: Performance of cfDNA methylation-based model for discriminating pancreatic cancer versus non-cancer
timeFrame: 12 months
Secondary outcomes:
measure: Performance of models using multi-omic data for discriminating pancreatic cancer versus non-cancer
timeFrame: 12 months
measure: Performance of pre-defined model in clinical sub-groups of interest
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Department of Hepato-Biliary-Pancreatic-Splenic Surgery, Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Department of General Sugery, Huadong Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xian-Jun Yu, M.D., Ph.D.
role: STUDY_CHAIR
References: