iDentification and vAlidation Model of Liquid biopsY Based cfDNA Methylation and pRotEin biomArKers for Pancreatic Cancer (DAYBREAK Study)

August 9, 2022 updated by: Guo ShiWei, Changhai Hospital

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

DAYBREAK is a prospective, multi-omics, observational study aimed at early detecting pancreatic cancer by combined assays for biomarkers of cfDNA methylation, serum protein markers, blood miRNA markers and others, in which of 450 participants will be enrolled. The development and validation of the model will be conducted in participants with early stage cancers and benign disease through a two-stage approach. The sensitivity and specificity of the model in pancreatic cancer early detection will be evaluated.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

450

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

  • Name: Shiwei Guo, M.D.
  • Phone Number: 18621500666
  • Email: gestwa@163.com

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Shanghai Changhai Hospital
        • Contact:

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible participants will be recruited from medical centers and assigned into two arms, including participants with new diagnosis of malignancy or corresponding benign disease.

Description

Inclusion Criteria for Cancer Arm Participants:

  • Able to provide a written informed consent.
  • Able to provide sufficient and qualified blood samples for study tests.
  • No prior or undergoing cancer treatment (local or systematic) with either of the following:
  • A. Pathologically confirmed cancer diagnosis within 42 days prior to the study blood draw.
  • B. High suspicious for cancer diagnosis by radiological or other routine clinical assessments, with confirmed cancer diagnosis through biopsy or surgical resection within 42 days after study blood draw.

Exclusion Criteria for 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 30 days prior to study blood draw.
  • With other known malignant tumors or multiple primary tumors.

Inclusion Criteria for Benign Disease Arm Participants:

  • 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 30 days prior to study blood draw.
  • Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The sensitivity and specificity of multi-cancer early detection by the combined model in cancer arm and benign disease arm
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The difference of sensitivity and specificity in pancreatic cancer participants at different clinical stages.
Time Frame: 12 months
12 months
Sensitivity and specificity for detecting pancreatic cancer of a cfDNA methylation-based model, in combination with other biomarkers.
Time Frame: 12 months
12 months
Sensitivity and specificity for detecting pancreatic cancer of a the protein panel-based model, in combination with other biomarkers.
Time Frame: 12 months
12 months
Sensitivity and specificity of the blood miRNA-based model in detecting pancreatic cancer.
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Changhai Hospital

Collaborators

Guangzhou Burning Rock Bioengineering Ltd.

Investigators

  • Study Chair: Gang Jin, M.D., Department of general surgery, Changhai Hospital

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)

March 24, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

August 9, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHEC2022-030

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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