Next Generation pErsonalized tX(Therapy) With Plasma DNA Trial-2 in Refractory Solid Tumors (The NEXT-2 Trial)
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.
Studieoversikt
Status
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Seoul, Korea, Republikken, 99999
- Samsung Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Annen
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
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metastatic cancer
metastatic gastrointestinal cancer metastatic genitourinary cancer other rare cancer lung cancer
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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feasibility
Tidsramme: 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 ]
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The feasibility of the use of plasma cell free DNA - molecular profiling to direct targeted therapies in the treatment of refractory solid tumors -ANALYSIS : The analysis of this exploratory study will be primarily descriptive. Data will be presented by means of summary statistics tables, graphs and listings. |
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 ]
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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progression free survival (PFS),
Tidsramme: 1years
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The progression free survival (PFS), duration of response and overall survival of patients with refractory solid tumors.
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1years
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molecular profile with cell-free DNA
Tidsramme: 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 ]
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To compare the correlation between primary/metastatic tumor formalin-fixed paraffin-embedded DNA molecular profile with cell-free DNA from plasma
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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 ]
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serial cfDNA samples
Tidsramme: 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 ]
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To evaluate changes in the tumor's molecular profile on serial cfDNA samples when patients progress after an initial response to targeted treatment
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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 ]
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Duration of response
Tidsramme: 1years
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The progression free survival (PFS), duration of response and overall survival of patients with refractory solid tumors.
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1years
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overall survival
Tidsramme: 1years
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The progression free survival (PFS), duration of response and overall survival of patients with refractory solid tumors.
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1years
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response rate
Tidsramme: up to 1 year
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The response rate of molecular-profile directed treatments in refractory solid tumors
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up to 1 year
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Won Ki Kang, MD, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2013-11-014
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