A Prospective Study of Liquid Biopsy for Pancreatic Cancer Early Detection

Pancreatic Cancer Clinical Trial

Official title:

A Proof of Concept Study of Pancreatic Cancer Early Detection by cfDNA Assay

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06166147
• Other study ID #: Profound-PC
• Status: Not yet recruiting
• Start date: December 22, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: December 2023
• Source: Fudan University
• Contact: Xian-Jun Yu, M.D., Ph.D.
• Phone: +86 21 64175590
• Email: yuxianjun[@]fudanpci.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 276
• Est. completion date: March 31, 2027
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
China	Department of Biliary Pancreatic Surgery, Shanghai Changzheng Hospital, The Second Military Medical University	Shanghai	Shanghai
China	Department of General Sugery, Huadong Hospital	Shanghai	Shanghai
China	Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Shanghai Weihe Medical Laboratory Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of cfDNA methylation-based model for discriminating pancreatic cancer versus non-cancer	Sensitivities of cfDNA methylation-based model at specificity of 99% and 95%, respectively.	12 months
Secondary	Performance of models using multi-omic data for discriminating pancreatic cancer versus non-cancer	Sensitivities of model integrating multi-omics data at specificity of 99% and 95%,respectively.	12 months
Secondary	Performance of pre-defined model in clinical sub-groups of interest	Sensitivity of pre-defined model in different pathological subtypes or different age groups or tumor marker-negative cases.	12 months