Cell-free DNA Quantification for Predictive Marker of Palliative Chemotherapy

Biomarkers Clinical Trial

Official title:

Usefulness of Cell-free DNA Quantification With Fluorescent Assay in Response Evaluation of Palliative Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227950
• Other study ID #: CFD-3
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2022
• Source: Pusan National University Yangsan Hospital
• Contact: Kwonoh Park, MD, phD
• Phone: +82-055-530-2366
• Email: parkkoh[@]daum.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients with histologically or cytologically confirmed initially metastatic or recurrent cancer who are expected to undergo primary palliative chemotherapy (patients who relapse after adjuvant chemotherapy before/after existing surgery can also be enrolled regardless of period)

• Patients with definitive tumor burden (Patients who do not have residual lesions due to metastasectomy are excluded. However, measurable lesions according to RECIST 1.1 are not mandatory, and evaluable lesions are possible)

• ECOG PS 0-2

• Adequate bone marrow, renal function, liver function to receive chemotherapy

• Patients with informed consent form

Exclusion Criteria:

• Patients with treating antibiotic treatment within 3 days of study enrollment due to overt or suspected infection

• Other serious illness or medical condition

Related Conditions & MeSH terms

• Biomarkers
• Fluorescence
• Palliative Chemotherapy

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Agostini M, Pucciarelli S, Enzo MV, Del Bianco P, Briarava M, Bedin C, Maretto I, Friso ML, Lonardi S, Mescoli C, Toppan P, Urso E, Nitti D. Circulating cell-free DNA: a promising marker of pathologic tumor response in rectal cancer patients receiving pre — View Citation

Czeiger D, Shaked G, Eini H, Vered I, Belochitski O, Avriel A, Ariad S, Douvdevani A. Measurement of circulating cell-free DNA levels by a new simple fluorescent test in patients with primary colorectal cancer. Am J Clin Pathol. 2011 Feb;135(2):264-70. do — View Citation

Goldshtein H, Hausmann MJ, Douvdevani A. A rapid direct fluorescent assay for cell-free DNA quantification in biological fluids. Ann Clin Biochem. 2009 Nov;46(Pt 6):488-94. doi: 10.1258/acb.2009.009002. Epub 2009 Sep 3. — View Citation

Kim JJ, Park K, Han YR, Kim SH, Oh SB, Oh SY, Hong YJ, Yun MS. Verification of performance of a direct fluorescent assay for cell-free DNA quantification, stability according to pre-analytical storage conditions, and the effect of freeze-thawing. Biomed R — View Citation

Leon SA, Shapiro B, Sklaroff DM, Yaros MJ. Free DNA in the serum of cancer patients and the effect of therapy. Cancer Res. 1977 Mar;37(3):646-50. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relationship between CFD and tumor burden	Confirmation of relationship between baseline CFD value and primary tumor size and number of metastatic sites	2 year
Secondary	correlation between change of CFD value and radiologic response	Confirmation of correlation between CFD change value and imaging response (PR/CR versus SD/PD)	2 years
Secondary	relationship between baseline CFD and tumor marker	Confirmation of relationship between baseline CFD value and other tumor markers (CEA, CA19-9, CA125, PSA) and LDH	2 years
Secondary	correlation between change of CFD value and change of tumor marker	Confirmation of relationship between change of CFD value and change of other tumor markers (CEA, CA19-9, CA125, PSA) and LDH	2 years