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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer arm<br>Participants with new diagnosis of pancreatic cancer, from whom a blood sample will be collected. | |
| Benign disease arm<br>Participants with benign pancreatic diseases, from whom a blood sample will be collected. | |
| Healthy arm<br>Participants with no known presence of malignancies or benign diseases, from whom a blood sample will be collected. | |
| High risk for pancreatic cancer arm<br>Participants with high risk for pancreatic cancer, from whom a blood sample will be collected. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the cfDNA methylation-based model in detecting pancreatic cancer. |  | 30 months | 
| The performance of the cfDNA methylation-based model in pancreatic cancer early detection in participants at high risk for pancreatic cancer. |  | 90 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of sensitivity and specificity in pancreatic cancer participants at different clinical stages. |  | 30 months | 
| Sensitivity and specificity for detecting pancreatic cancer of a cfDNA methylation-based model, in combination with other biomarkers. |  | 30 months | 
| Sensitivity and specificity of a ctDNA mutation-based model and a serum protein-based model in detecting pancreatic cancer, respectively. |  | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, liquid biopsy, cell-free DNA (cfDNA) methylation, circulating tumor DNA (ctDNA) mutation, whole blood miRNA