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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
-
Seoul, Korea, Republik von, 99999
- Samsung Medical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Sonstiges
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
metastatic cancer
metastatic gastrointestinal cancer metastatic genitourinary cancer other rare cancer lung cancer
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
feasibility
Zeitfenster: 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 ]
|
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 ]
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
progression free survival (PFS),
Zeitfenster: 1years
|
The progression free survival (PFS), duration of response and overall survival of patients with refractory solid tumors.
|
1years
|
|
molecular profile with cell-free DNA
Zeitfenster: 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 ]
|
To compare the correlation between primary/metastatic tumor formalin-fixed paraffin-embedded DNA molecular profile with cell-free DNA from plasma
|
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 ]
|
|
serial cfDNA samples
Zeitfenster: 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 ]
|
To evaluate changes in the tumor's molecular profile on serial cfDNA samples when patients progress after an initial response to targeted treatment
|
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 ]
|
|
Duration of response
Zeitfenster: 1years
|
The progression free survival (PFS), duration of response and overall survival of patients with refractory solid tumors.
|
1years
|
|
overall survival
Zeitfenster: 1years
|
The progression free survival (PFS), duration of response and overall survival of patients with refractory solid tumors.
|
1years
|
|
response rate
Zeitfenster: up to 1 year
|
The response rate of molecular-profile directed treatments in refractory solid tumors
|
up to 1 year
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Won Ki Kang, MD, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2013-11-014
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Urogenitaler Krebs
-
Palacky UniversityCB21 Pharma Ltd.AbgeschlossenWechseljahre und Genitourinary -SyndromTschechische Republik