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

May 4, 2023 updated by: Ruijin Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

7062

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Qian Zhan, M.D.
  • Phone Number: +86-021-64370045 ext. 670903
  • Email: zhanxi80@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Qian Zhan, MD
          • Phone Number: +86-021-64370045 ext. 670903
          • Email: zhanxi80@126.com
      • Shanghai, Shanghai, China
        • Active, not recruiting
        • Huashan Hospital, Fudan University
      • Shanghai, Shanghai, China
        • Active, not recruiting
        • Zhongshan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Eligible participants will be recruited from medical centers and assigned into three arms to develop a predictive diagnostic model in pancreatic cancer, including participants with new diagnosis of malignancy or corresponding benign disease and participants without the presence of malignancy or benign diseases. Participants with high risk for pancreatic cancer will be recruited from medical centers to evaluate the performance of pancreatic cancer early detection test.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of a blood miRNA-based model in detecting pancreatic cancer.
Time Frame: 30 months
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Guangzhou Burning Rock Dx Co., Ltd.

Investigators

  • Study Director: Baiyong Shen, M.D.&Ph.D, Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2022

Primary Completion (Anticipated)

June 30, 2029

Study Completion (Anticipated)

December 31, 2029

Study Registration Dates

First Submitted

September 25, 2022

First Submitted That Met QC Criteria

September 25, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RSCD2022003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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