Cell-free DNA Quantification for Predictive Marker of Palliative Chemotherapy

NCT05227950 | Unknown

• 1 other identifier: CFD-3
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is design to address, as follows:

1. 1.correlation between fluorescence-based CFD measurements and tumor burden (primary tumor size, number of metastatic sites)
2. 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.

Conditions

Cell-Free Nucleic Acids; Biomarkers; Fluorescence; Palliative Chemotherapy

Keywords

cell-free nucleic acids; biomarkers; palliative chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• correlation between change of CFD value and radiologic response

  2 years

• relationship between baseline CFD and tumor marker

  2 years

• correlation between change of CFD value and change of tumor marker

  2 years

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients with treating antibiotic treatment within 3 days of study enrollment due to overt or suspected infection
• Other serious illness or medical condition

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

Related Publications (5)

• 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.

  PMID: 837366 RESULT

• 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.

  PMID: 21416156 RESULT

• 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.

  PMID: 19729503 RESULT

• 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.

  PMID: 21228367 RESULT

• 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.

  PMID: 34257964 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

quantification of fluorescence based cell-free DNA

Study Officials

• Kwonoh Park, MD, phD

  Medical Oncology and Hematology, Department of Internal medicine, Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kwonoh Park, MD, phD

CONTACT

+82-055-530-2366; parkkoh@daum.net

Sujin Kim

CONTACT

ssujin0206@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 8, 2022
• Study Start: January 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)