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Trial Title:
iDentification and vAlidation Model of Liquid biopsY Based cfDNA Methylation and pRotEin biomArKers for Pancreatic Cancer (DAYBREAK Study)
NCT ID:
NCT05495685
Condition:
Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
pancreatic cancer
liquid biopsy
cell-free DNA (cfDNA) methylation
whole blood miRNA
others
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Eligible participants will be recruited from medical centers and assigned into two arms,
including participants with new diagnosis of malignancy or corresponding benign disease.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
40 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Shanghai Changhai Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Shiwei Guo, M.D.
Phone:
18621500666
Email:
gestwa@163.com
Investigator:
Last name:
Gang Jin, M.D.
Email:
Principal Investigator
Start date:
March 24, 2022
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Collaborator:
Agency:
Guangzhou Burning Rock Bioengineering Ltd.
Agency class:
Industry
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05495685
