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

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
SUMMARY

ASCEND-PANCREATIC is a prospective, multi-omics, observational study aimed at early detecting pancreatic cancer by combined assays for biomarkers of cfDNA methylation, circulating tumor DNA (ctDNA) mutation, serum protein markers and blood miRNA markers, in which of 7,062 participants will be enrolled. The development and validation of the model will be conducted in participants with early stage cancers or benign diseases, along with healthy individuals. The performance of the pancreatic cancer detection test will be evaluated in participants with high risk of pancreatic cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: t
View:

• 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.

• 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.

• 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.

• 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.

Locations
Other Locations
China
Huashan Hospital, Fudan University
ACTIVE_NOT_RECRUITING
Shanghai
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Zhongshan Hospital, Fudan University
ACTIVE_NOT_RECRUITING
Shanghai
Contact Information
Primary
Qian Zhan, M.D.
zhanxi80@126.com
+86-021-64370045 ext. 670903
Backup
Yuzi Zhang, M.D.
Z_Zhangyuzi@163.com
+86-021-60293798
Time Frame
Start Date: 2022-12-28
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 7062
Treatments
Cancer arm
Participants with new diagnosis of pancreatic cancer, from whom a blood sample will be collected.
Benign disease arm
Participants with benign pancreatic diseases, from whom a blood sample will be collected.
Healthy arm
Participants with no known presence of malignancies or benign diseases, from whom a blood sample will be collected.
High risk for pancreatic cancer arm
Participants with high risk for pancreatic cancer, from whom a blood sample will be collected.
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital
Collaborators: Guangzhou Burning Rock Dx Co., Ltd.

This content was sourced from clinicaltrials.gov