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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
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• 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

• 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

• 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

Locations
Other Locations
China
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China
RECRUITING
Shanghai
Contact Information
Primary
Xian-Jun Yu, M.D., Ph.D.
yuxianjun@fudanpci.org
+86-21-64175590
Time Frame
Start Date: 2024-06-28
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 480
Treatments
Cancer arm
Participants with new diagnosis of pancreatic cancer.
Precancerous lesions arm
Participants with precancerous lesions.
Healthy individuals arm
Healthy individuals without findings of clinical significance during routine health checkups.
Related Therapeutic Areas
Sponsors
Leads: Fudan University
Collaborators: Nanjing Simcere Medical Laboratory Science Co., Ltd.

This content was sourced from clinicaltrials.gov