IDentification And VAlidation Model Of Liquid BiopsY Based CfDNA Methylation And PRotEin BiomArKers For Pancreatic Cancer (DAYBREAK Study)

Study Overview

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

N/A

Cancer

CHEC2022-030

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-08-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-08-09
First Submitted that Met QC Criteria 2022-08-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-08-10
First Posted (ACTUAL) 2022-08-10	Results First Posted N/A	Last Verified 2022-08

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: 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.

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

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

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

Name: Yuzi Zhang, M.D.

Phone Number: +86-021-60293798

Email: Z_Zhangyuzi@163.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
40 Years

Accepts Healthy Volunteers:
1

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.

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.

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.

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

Collaborators and Investigators

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

Guangzhou Burning Rock Bioengineering Ltd.

Investigators

STUDY_CHAIR: Gang Jin, M.D., Department of general surgery, Changhai Hospital

Publications

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

General Publications

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