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Recruiting NCT05556603

AssesSment of Early-deteCtion basEd oN liquiD Biopsy in PANCEATIC Cancer (ASCEND-PANCREATIC)

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Trial Parameters

Condition Cancer
Sponsor Ruijin Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 7,062
Sex ALL
Min Age 40 Years
Max Age 75 Years
Start Date 2022-12-28
Completion 2029-06-30

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Brief 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 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 t

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