iDentification and vAlidation Model of Liquid biopsY Based cfDNA Methylation and pRotEin biomArKers for Pancreatic Cancer (DAYBREAK Study)
NCT ID: NCT05495685
Last Updated: 2022-08-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
450 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-03-24
Study Completion Date
2024-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Cancer
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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Cancer arm
Participants with new diagnosis of pancreatic cancer, from whom a blood sample will be collected.
No interventions assigned to this group
Benign disease arm
Participants with benign pancreatic diseases, from whom a blood sample will be collected.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
* 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.
* 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
* 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.
* 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
* 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.
* 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
Minimum Eligible Age
40 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Guangzhou Burning Rock Bioengineering Ltd.
INDUSTRY
Sponsor Role
collaborator
Changhai Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Guo ShiWei
Associated Professor at the Institute of Pancreatic Surgery
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Gang Jin, M.D.
Role: STUDY_CHAIR
Department of general surgery, Changhai Hospital
Locations
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Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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CHEC2022-030
Identifier Type: -
Identifier Source: org_study_id
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