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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495685
• Other study ID #: CHEC2022-030
• Status: Recruiting
• Start date: March 24, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2022
• Source: Changhai Hospital
• Contact: Shiwei Guo, M.D.
• Phone: 18621500666
• Email: gestwa[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
China	Shanghai Changhai Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Changhai Hospital	Guangzhou Burning Rock Bioengineering Ltd

Country where clinical trial is conducted

China, 

References & Publications (52)

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* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity and specificity of multi-cancer early detection by the combined model in cancer arm and benign disease arm		12 months
Secondary	The difference of sensitivity and specificity in pancreatic cancer participants at different clinical stages.		12 months
Secondary	Sensitivity and specificity for detecting pancreatic cancer of a cfDNA methylation-based model, in combination with other biomarkers.		12 months
Secondary	Sensitivity and specificity for detecting pancreatic cancer of a the protein panel-based model, in combination with other biomarkers.		12 months
Secondary	Sensitivity and specificity of the blood miRNA-based model in detecting pancreatic cancer.		12 months