Cell-free DNA Quantification for Predictive Marker of Palliative Chemotherapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Biomarkers; Fluorescence; Cell-Free Nucleic Acids; Palliative Chemotherapy

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Kwonoh Park, MD, phD; Phone Number: +82-055-530-2366; Email: parkkoh@daum.net
• Study Contact Backup: Name: Sujin Kim; Email: ssujin0206@naver.com

Study Locations

• Korea, Republic of
  • Gyeongsangnam-do
    • Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
      • Recruiting
      • Pusan National University Yangsan Hospital
      • Contact: Kwonoh Park, MD, PhD; Phone Number: 82+0555302366; Email: parkkoh@daum.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically or cytologically confirmed initially metastatic or recurrent cancer who are expected to undergo primary palliative chemotherapy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Principal Investigator: Kwonoh Park, MD, phD, Medical Oncology and Hematology, Department of Internal medicine, Pusan National University Yangsan Hospital

Publications and helpful links

General Publications

• 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.
• 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 preoperative chemoradiotherapy. Ann Surg Oncol. 2011 Sep;18(9):2461-8. doi: 10.1245/s10434-011-1638-y. Epub 2011 Mar 17.
• 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.
• 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. doi: 10.1309/AJCP4RK2IHVKTTZV.
• 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 Rep. 2021 Aug;15(2):68. doi: 10.3892/br.2021.1444. Epub 2021 Jun 15.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2022
• Primary Completion (ANTICIPATED): June 30, 2024
• Study Completion (ANTICIPATED): June 30, 2024

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (ACTUAL): February 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: biomarkers; palliative chemotherapy; cell-free nucleic acids
• Other Study ID Numbers: CFD-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No