Clinical trial NCT05495685: iDentification and vAlidation Model of Liquid biopsY Based cfDNA Methylation and pRotEin biomArKers for Pancreatic Cancer (DAYBREAK Study)
Official title: Pancreatic Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: pancreatic cancer
liquid biopsy
cell-free DNA (cfDNA) methylation
whole blood miRNA
others
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Guangzhou Burning Rock Bioengineering Ltd.
First posted: 2022-08-10
Enrollment: 450
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The sensitivity and specificity of multi-cancer early detection by the combined model in cancer arm and benign disease arm
timeFrame: 12 months
Secondary outcomes:
measure: The difference of sensitivity and specificity in pancreatic cancer participants at different clinical stages.
timeFrame: 12 months
measure: Sensitivity and specificity for detecting pancreatic cancer of a cfDNA methylation-based model, in combination with other biomarkers.
timeFrame: 12 months
measure: Sensitivity and specificity for detecting pancreatic cancer of a the protein panel-based model, in combination with other biomarkers.
timeFrame: 12 months
measure: Sensitivity and specificity of the blood miRNA-based model in detecting pancreatic cancer.
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
Study officials:
affiliation: Department of general surgery, Changhai Hospital
name: Gang Jin, M.D.
role: STUDY_CHAIR
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