Pancreatic Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTA noninvasive cfDNA multi-omics assay
Peripheral venous blood samples will be collected from pancreatic cancer patients, individuals with precancerous lesions, and healthy controls. Subsequently, cfDNA will be extracted and subjected to low-pass whole genome sequencing (LP-WGS) and hybrid capture-based targeted methylation sequencing (TMS).
Sponsors
Nanjing Simcere Medical Laboratory Science Co., Ltd.
Fudan University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of cfDNA multi-omics model for discriminating pancreatic cancer versus healthy individuals. | 12 months | The area under the curve (AUC), sensitivity and specificity of cfDNA multi-omics model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of cfDNA multi-omics model for discriminating patients with pancreatic cancer and precancerous lesions versus healthy individuals. | 12 months | Sensitivity of cfDNA multi-omics model at specificity of 95% for discriminating patients with pancreatic cancer and precancerous lesions versus healthy individuals. |
| Performance of cfDNA multi-omics model for discriminating precancerous lesions versus healthy individuals. | 12 months | Sensitivity of cfDNA multi-omics model for discriminating precancerous lesions versus healthy individuals. |
| Performance of pre-defined model in clinical sub-groups of interest. | 12 months | Sensitivity of cfDNA multi-omics model for pancreatic cancer at different stages or in different pathological subtypes. |
Countries
China
Contacts
Primary ContactXian-Jun Yu, M.D., Ph.D.
Outcome results
None listed