Developing a blood test for pancreatic cancer screening using DNA analysis

Development and Validation of Multi-omics Model for Screening of Pancreatic Cancer Using cfDNA

This study is testing a new blood test that looks for signs of pancreatic cancer by analyzing DNA from blood samples to see if it can help catch the disease early.

Quick facts

• Study type: Observational
• Enrollment: 480 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06456281 on ClinicalTrials.gov

What this trial studies

This observational study aims to create a precise diagnostic model for screening pancreatic cancer by analyzing cell-free DNA (cfDNA) from blood samples. Participants include individuals with newly diagnosed pancreatic cancer, precancerous lesions, and healthy controls. The study will utilize low-pass whole-genome sequencing and targeted methylation sequencing to identify cancer-specific signatures. An ensemble multi-omics model will be developed and validated using machine learning algorithms to distinguish pancreatic cancer from non-cancer cases.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a clinically or pathologically diagnosed pancreatic cancer who have not received any prior antitumor therapy.

Not a fit: Patients with other malignancies, severe infections, or those who have recently undergone certain medical treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier and more accurate detection of pancreatic cancer, improving patient outcomes.

How similar studies have performed: While the approach of using cfDNA for cancer detection is gaining traction, this specific multi-omics model for pancreatic cancer screening is relatively novel and has not been extensively tested in prior studies.

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

Where this trial is running

Shanghai, Shanghai Municipality

• Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xian-Jun Yu, M.D., Ph.D.

Conditions Pancreatic Cancer