Clinical trial NCT02140463: Next Generation pErsonalized tX(Therapy) With Plasma DNA Trial-2 in Refractory Solid Tumors (The NEXT-2 Trial)
Official title: Next Generation pErsonalized tX(Therapy) With Plasma DNA Trial-2 in Refractory Solid Tumors (The NEXT-2 Trial)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Gastrointestinal Cancer
Genitourinary Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-05-16
Enrollment: 229
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pathologically confirmed cancer patient

Brief summary: Analysis of cell free DNA(cfDNA), unlike tissue biopsy, presents a new tool for the monitoring and treatment of cancer. The investigators have developed a differentiated sequencing assay, Digital Sequencing Technology (DST) that enables detection of rare genomic abnormalities with ultra high-specificity and sensitivity. The investigators assay is able to eliminate the error and distortion created by sample-prep and sequencing processes in standard NGS(next-generation sequencing ) workflows and produce near-perfect representations of all rare variants.

The investigators have shown that in sequencing a comprehensive cancer panel of 80kbp in 0.1% cancer cell line titration samples, standard Illumina SBS(sequencing by synthesis ) generates many high-quality false positive variant calls in the range of 0.05-5%, while the investigators assay resulted in highly sensitive and completely error-free variant calls across the entire panel.

This work indicates the remarkable potential of using the investigators assay in deep analysis of cfDNA, thereby allowing researchers and clinicians to comprehensively and non-invasively monitor the genetic dimension of cancer throughout the body.

Detailed description: Same as above

Eligibility criteria: Inclusion Criteria:

* Patients older than 20 years
* Patients with histologically confirmed metastatic gastrointestinal cancer, rare cancer, lung cancer
* Patients with histologically confirmed metastatic cancer, who do not have sufficient biopsy material to undergo mutational testing of their tumor, or do not have feasible biopsy sites; melanoma/lung cancer and any solid tumor cancer types will be eligible for the study.
* Written informed consent form

Exclusion Criteria:

* Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.
* Double primary cancer (except for any cancer in remission for \> 5 years, cervix cancer in situ, basal cell cancer in situ, any in situ cancers that are resected)

Primary outcomes:
measure: feasibility
timeFrame: From date of start of targeted treatment oriented by NEXT until the date of first progression or date of death from any cause, whichever came first, assessed up to 1 year ]
Secondary outcomes:
measure: progression free survival (PFS),
timeFrame: 1years
measure: molecular profile with cell-free DNA
timeFrame: From date of start of targeted treatment oriented by NEXT until the date of first progression or date of death from any cause, whichever came first, assessed up to 1 year ]
measure: serial cfDNA samples
timeFrame: From date of start of targeted treatment oriented by NEXT until the date of first progression or date of death from any cause, whichever came first, assessed up to 1 year ]
measure: Duration of response
timeFrame: 1years
measure: overall survival
timeFrame: 1years
measure: response rate
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
name: Won Ki Kang, MD
role: STUDY_CHAIR
References: