A Prospective Study of Liquid Biopsy for Pancreatic Cancer Early Detection

Last updated: September 15, 2024
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatic Cancer

Digestive System Neoplasms

Pancreatitis

Treatment

N/A

Clinical Study ID

NCT06166147
Profound-PC
  • Ages 40-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 notlimited to surgical resection, radiochemotherapy, endocrinotherapy, targetedtherapy, immunotherapy, interventional therapy, etc.

  • Able to provide a written informed consent and willing to comply with all part ofthe protocol procedures.

Exclusion

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 febrileillness (body temperature of ≥ 38.0 °C) within 14 days prior to blood draw

  • Recipients of organ transplant or prior bone marrow transplant or stem celltransplant

  • 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 IVantibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine,arsenic trioxide

  • Other conditions that the investigators considered are not suitable for theenrollment

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 notlimited to surgical resection, radiochemotherapy, endocrinotherapy, targetedtherapy, immunotherapy, interventional therapy, etc.

  • Able to provide a written informed consent and willing to comply with all part ofthe 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 febrileillness (body temperature of ≥ 38.0 °C) within 14 days prior to blood draw

  • Recipients of organ transplant or prior bone marrow transplant or stem celltransplant

  • 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 IVantibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine,arsenic trioxide

  • Other conditions that the investigators considered are not suitable for theenrollment

Study Design

Total Participants: 276
Study Start date:
December 18, 2023
Estimated Completion Date:
March 31, 2027

Study 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.

Connect with a study center

  • Department of Biliary Pancreatic Surgery, Shanghai Changzheng Hospital, The Second Military Medical University

    Shanghai, Shanghai 200003
    China

    Site Not Available

  • Department of General Sugery, Huadong Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Department of Hepato-Biliary-Pancreatic-Splenic Surgery, Shanghai General Hospital

    Shanghai, Shanghai 200080
    China

    Active - Recruiting

  • Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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