Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-28 @ 10:55 AM
Study NCT ID:
NCT05227950
Status:
UNKNOWN
Last Update Posted:
2022-02-08
First Post:
2022-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cell-free DNA Quantification for Predictive Marker of Palliative Chemotherapy
Sponsor:
Pusan National University Yangsan Hospital
Organization:
Study Overview
Official Title:
Usefulness of Cell-free DNA Quantification With Fluorescent Assay in Response Evaluation of Palliative Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is design to address, as follows:
1. correlation between fluorescence-based CFD measurements and tumor burden (primary tumor size, number of metastatic sites)
2. fluorescence-based CFD measurements and changes are related to tumor response. Based on the results of this study, the role of fluorescence-based CFD as a predictive biomarker for palliative chemotherapy is to be confirmed.
1. correlation between fluorescence-based CFD measurements and tumor burden (primary tumor size, number of metastatic sites)
2. fluorescence-based CFD measurements and changes are related to tumor response. Based on the results of this study, the role of fluorescence-based CFD as a predictive biomarker for palliative chemotherapy is to be confirmed.
Detailed Description:
* It is important to check the response to chemotherapy. Currently, it is mostly evaluated as a radiologic response or, rarely the change of tumor markers.
* In the case of radiologic response tests at intervals of 6-8 weeks, there are cases where the economic burden and radiation exposure risk, additionally evaluation lesion is lack in a few case. Except for prostate cancer and ovarian cancer, the majority of carcinomas do not have cancer markers for assessing treatment response. Therefore, there is a need for biomarkers that can predict the response of anticancer treatment.
* In many studies, it has been reported that various types of circulating cell free DNA (CFD) are increased in various cancer types.
* Recently, a fluorescence based CFD method that can directly measure nucleic acids without a DNA extraction process has been developed, which makes testing simpler and more economical, and can be conveniently applied to cancer diagnosis and treatment response.
* This study is plan to evaluate the relationship between fluorescence-based CFD and treatment response in patients starting palliative chemotherapy, and check whether it can serve as a response evaluation for palliative chemotherapy.
* In the case of radiologic response tests at intervals of 6-8 weeks, there are cases where the economic burden and radiation exposure risk, additionally evaluation lesion is lack in a few case. Except for prostate cancer and ovarian cancer, the majority of carcinomas do not have cancer markers for assessing treatment response. Therefore, there is a need for biomarkers that can predict the response of anticancer treatment.
* In many studies, it has been reported that various types of circulating cell free DNA (CFD) are increased in various cancer types.
* Recently, a fluorescence based CFD method that can directly measure nucleic acids without a DNA extraction process has been developed, which makes testing simpler and more economical, and can be conveniently applied to cancer diagnosis and treatment response.
* This study is plan to evaluate the relationship between fluorescence-based CFD and treatment response in patients starting palliative chemotherapy, and check whether it can serve as a response evaluation for palliative chemotherapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: