DNA Mutation Detection in Circulating Tumor DNA and Tissue by mmADPS for Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

DNA Mutation Detection in Circulating Tumor DNA and Tissue by Massive Multiplex Allele Discrimination Priming System(mmADPS) for Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05604573
• Other study ID #: H-2111-047-1271
• Status: Recruiting
• Start date: February 9, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: Seoul National University Hospital
• Contact: Sang Hyub Lee, Ph.D
• Phone: +82-2-2072-2228
• Email: gidoctor[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Based on the cell free nucleic acid analysis information of blood samples and genetic mutation profile of EUS-FNB tissue from pancreatic cancer, the concordance between them is evaluated. And based on this information, biomarkers for diagnosis, treatment, and prognosis of pancreatic cancer are explored.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins

• Patients aged 18 or older who voluntarily agrees to participate in the study and is willing to understand and comply with the subsequent treatment procedures and sample collection schedule

• Among patients diagnosed with benign pancreatic diseases (pancreatic cyst, chronic pancreatitis, etc.), patients who have need for histological examination as control group

Exclusion Criteria:

• Where the subject himself/herself refuses to fill out the consent form or is unable to fill out the consent form

• If a laboratory test is impossible due to a qualitative problem with the collected blood sample

• Where the collected tissue does not contain tissue of the desired malignant or benign disease

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• cell free DNA in blood, genetic mutation in tissue
Diagnostic test for cell free DNA in blood, genetic mutation in tissue

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	GENECAST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation of genetic mutation	concordance of genetic mutation between tissue and blood of treatment-naive status	the day of study enrollment (baseline)
Primary	detection sensitivity of genetic mutation by mmADPS	detection sensitivity of genetic mutation by mmADPS	the day of study enrollment (baseline)
Secondary	correlation of genetic mutation and prognosis	correlation of genetic mutation and prognosis	through study completion, an average of 1 year