Developing a blood test for early detection of pancreatic cancer
A Proof of Concept Study of Pancreatic Cancer Early Detection by cfDNA Assay
Fudan University · NCT06166147
This study is testing a new blood test to see if it can help find pancreatic cancer early by looking for specific signals in the blood of people who have just been diagnosed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 276 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University (other) |
| Drugs / interventions | immunotherapy |
| Locations | 3 sites (Shanghai, Shanghai Municipality and 2 other locations) |
| Trial ID | NCT06166147 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a machine learning-based model for the early detection of pancreatic cancer using liquid biopsy samples. Participants with newly diagnosed pancreatic cancer will provide peripheral blood samples to analyze cancer-specific signals through sequencing of cell-free DNA. The study will evaluate the effectiveness of this noninvasive test in distinguishing cancer from non-cancer cases, including benign diseases and average-risk individuals, using a two-stage validation approach.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40-75 who have been clinically or pathologically diagnosed with pancreatic cancer and have not received any prior antitumor therapy.
Not a fit: Patients with other malignancies, severe infections, or those who have recently received certain therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of pancreatic cancer, improving treatment outcomes and survival rates.
How similar studies have performed: While there have been studies exploring liquid biopsies for cancer detection, this specific approach using machine learning for pancreatic cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai Municipality and 2 other locations
- Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)
- Department of Hepato-Biliary-Pancreatic-Splenic Surgery, Shanghai General Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
- Department of General Sugery, Huadong Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Xian-Jun Yu, M.D., Ph.D.
- Email: yuxianjun@fudanpci.org
- Phone: +86 21 64175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Cancer