Clinical trial NCT05227950: Cell-free DNA Quantification for Predictive Marker of Palliative Chemotherapy
Official title: Usefulness of Cell-free DNA Quantification With Fluorescent Assay in Response Evaluation of Palliative Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cell-Free Nucleic Acids
Biomarkers
Fluorescence
Palliative Chemotherapy
Keywords: cell-free nucleic acids
biomarkers
palliative chemotherapy
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: relationship between CFD and tumor burden
timeFrame: 2 year
Secondary outcomes:
measure: correlation between change of CFD value and radiologic response
timeFrame: 2 years
measure: relationship between baseline CFD and tumor marker
timeFrame: 2 years
measure: correlation between change of CFD value and change of tumor marker
timeFrame: 2 years
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
Study officials:
affiliation: Medical Oncology and Hematology, Department of Internal medicine, Pusan National University Yangsan Hospital
name: Kwonoh Park, MD, phD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.
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. doi: 10.1309/AJCP4RK2IHVKTTZV.
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 Rep. 2021 Aug;15(2):68. doi: 10.3892/br.2021.1444. Epub 2021 Jun 15.