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NCT06166147Recruiting

A Prospective Study of Liquid Biopsy for Pancreatic Cancer Early Detection

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

Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
276 (estimated)
First submitted
7 Nov 2023
Start date
18 Dec 2023
Primary completion date
31 Oct 2026
Lead sponsor
Fudan University
NCT number
NCT06166147

What you commit to

  • Study type: Observational
  • Planned participants: 276
  • From 18 Dec 2023 to the primary completion date, 31 Oct 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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 illness

  • Other conditions that the investigators considered are not suitable for the enrollment
    • Benign Disease Arm
  • Other conditions that the investigators considered are not suitable for the enrollment

Other

  • Pregnancy or lactating women
  • Pregnancy or lactating women

Who the study is looking for

  • 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.
  • 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

Criteria the registry did not label

  • Cancer Arm

Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Hepato-Biliary-Pancreatic-Splenic Surgery, Shanghai General Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Department of General Sugery, Huadong Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.