Clinical trial NCT06456281: Multi-omics Model for Pancreatic Cancer Screening Using cfDNA
Official title: Development and Validation of Multi-omics Model for Screening of Pancreatic Cancer Using cfDNA
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Nanjing Simcere Medical Laboratory Science Co., Ltd.
First posted: 2024-06-13
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed pancreatic cancer or precancerous lesions and healthy individuals.

Brief summary: This is a prospective case-control study, aiming at developing a cell free DNA (cfDNA) multi-omics precise diagnostic model for screening of pancreatic cancer.

Detailed description: Peripheral blood samples from participants with new diagnosis of pancreatic cancers, precancerous lesions and healthy individuals will be collected to characterize the cancer-specific signatures by low-pass whole-genome sequencing and target methylation sequencing using cfDNA. An ensemble multi-omics model will be trained aided by machine learning algorithm and validated in test set. The performance of this multi-omics model distinguishing pancreatic cancer from non-cancer will be evaluated.

Eligibility criteria: Cancer Arm

Inclusion Criteria:

* 18-75 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
* Physical status score ECOG 0-1

Exclusion Criteria:

* Pregnancy or lactating women
* Known prior or current diagnosis of other types of malignancies comorbidities
* Severe acute infection or febrile illness 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

Precancerous Lesions Arm

Inclusion Criteria:

* 18-75 years old
* Diagnosed with pancreatic intraepithelial tumor pancreatic intraepithelial lesions (PanINs), Intraductal papillary mucinous neoplasms (IPMN) or mucinous cystic neoplasms (MCN) by radiographical assess
* 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 or febrile illness 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

Healthy Individuals Arm

Inclusion Criteria:

* 18-75 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 or febrile illness 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 multi-omics model for discriminating pancreatic cancer versus healthy individuals.
timeFrame: 12 months
Secondary outcomes:
measure: Performance of cfDNA multi-omics model for discriminating patients with pancreatic cancer and precancerous lesions versus healthy individuals.
timeFrame: 12 months
measure: Performance of cfDNA multi-omics model for discriminating precancerous lesions versus healthy individuals.
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; 270 Dong An Road, Shanghai 200032, China
state: Shanghai
Study officials:
References: