Early detection of pancreatic cancer using liquid biopsy techniques

Pancreatic Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study

This study is testing a new blood test to see if it can help find pancreatic cancer early in people who are at high risk, as well as in those with other conditions and healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 7062 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Locations: 3 sites (Shanghai, Shanghai Municipality and 2 other locations)
• Trial ID: NCT05556603 on ClinicalTrials.gov

What this trial studies

ASCEND-PANCREATIC is a prospective observational study designed to detect pancreatic cancer at an early stage through a combination of biomarker assays, including cell-free DNA methylation, circulating tumor DNA mutations, serum protein markers, and blood miRNA markers. The study aims to enroll 7,062 participants, including those with early-stage cancers, benign diseases, and healthy individuals, to develop and validate a detection model. The effectiveness of the pancreatic cancer detection test will be assessed primarily in participants identified as high-risk for the disease.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 40-75 who are at high risk for pancreatic cancer and can provide informed consent.

Not a fit: Patients with prior cancer treatment or those currently undergoing treatment for other conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier diagnosis of pancreatic cancer, potentially improving treatment outcomes and survival rates.

How similar studies have performed: Other studies utilizing liquid biopsy techniques for cancer detection have shown promise, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria for Cancer Arm Participants:

* Age 40-75 years old.
* Able to provide a written informed consent.
* No prior cancer treatment (local or systematic) with either of the following:

A. Pathologically confirmed cancer diagnosis within 42 days prior to blood draw.

B. High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw.

Exclusion Criteria for Cancer Arm Participants:

* Insufficient qualified blood samples.
* During pregnancy or lactation.
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Recipient of blood transfusion within 7 days prior to blood draw.
* Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
* With other known malignant tumors or multiple primary tumors.

Inclusion Criteria for Benign Disease Arm Participants:

* Age 40-75 years old.
* Able to provide a written informed consent.
* Able to provide sufficient and qualified blood samples for study tests.
* Have either of the following:

A. Pathological confirmed diagnosis of benign diseases within 90 days prior to the study blood draw, with no prior treatment such as surgical resection.

B. High suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 42 days after study blood draw.

Exclusion Criteria for Benign Disease Arm Participants:

* Insufficient qualified blood sample for study test.
* During pregnancy or lactation.
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Recipient of blood transfusion within 7 days prior to study blood draw.
* Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.

Inclusion Criteria for Healthy Arm Participants:

* Age 40-75 years at the day of consenting to the study.
* Able to provide a written informed consent.
* Able to provide sufficient and qualified blood samples for study tests.
* No cancer related symptoms within 30 days prior to study screening.
* No abnormal medical examination within 30 days prior to screening.
* Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.

Exclusion Criteria for Healthy Arm Participants:

* Insufficient qualified blood sample for study test.
* During pregnancy or lactation.
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Recipient of blood transfusion within 7 days prior to study blood draw.
* Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
* Have received or are undergoing curative cancer treatment within three years prior to study screening.
* With autoimmune or other diseases with severe comorbidities.

Inclusion Criteria for High Risk for Pancreatic Cancer Arm Participants:

* Age 40-75 years old.
* Able to provide a written informed consent.
* Able to provide sufficient and qualified blood samples for study tests.
* Accompanied by known risk factors of pancreatic cancer, including carrier of any pathogenic variant, chronic pancreatitis and other risk factors.

Exclusion Criteria for High Risk for Pancreatic Cancer Arm Participants:

* Insufficient qualified blood sample for study test.
* During pregnancy or lactation.
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Recipient of blood transfusion within 7 days prior to study blood draw.
* Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
* Received radical therapy within 3 years and without recurrence, with malignant tumors with pathogenic or suspected pathogenic variants of germ-line genetic susceptibility genes.

Where this trial is running

Shanghai, Shanghai Municipality and 2 other locations

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Active_not_recruiting)
• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Active_not_recruiting)

Study contacts

• Study coordinator: Qian Zhan, M.D.

Conditions Cancer; liquid biopsy; cell-free DNA methylation; circulating tumor DNA mutation; whole blood miRNA