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Next Generation pErsonalized tX(Therapy) With Plasma DNA Trial-2 in Refractory Solid Tumors (The NEXT-2 Trial)

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ClinicalTrials.gov Identifier: NCT02140463
Recruitment Status : Recruiting
First Posted : May 16, 2014
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center

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.


Condition or disease
Metastatic Gastrointestinal Cancer Genitourinary Cancer

Detailed Description:
Same as above

Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Next Generation pErsonalized tX(Therapy) With Plasma DNA Trial-2 in Refractory Solid Tumors (The NEXT-2 Trial)
Study Start Date : February 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Group/Cohort
metastatic cancer
metastatic gastrointestinal cancer metastatic genitourinary cancer other rare cancer lung cancer



Primary Outcome Measures :
  1. feasibility [ Time Frame: 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.



Secondary Outcome Measures :
  1. progression free survival (PFS), [ Time Frame: 1years ]
    The progression free survival (PFS), duration of response and overall survival of patients with refractory solid tumors.

  2. molecular profile with cell-free DNA [ Time Frame: 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

  3. serial cfDNA samples [ Time Frame: 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

  4. Duration of response [ Time Frame: 1years ]
    The progression free survival (PFS), duration of response and overall survival of patients with refractory solid tumors.

  5. overall survival [ Time Frame: 1years ]
    The progression free survival (PFS), duration of response and overall survival of patients with refractory solid tumors.

  6. response rate [ Time Frame: up to 1 year ]
    The response rate of molecular-profile directed treatments in refractory solid tumors


Biospecimen Retention:   Samples With DNA
circulating free DNA


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
pathologically confirmed cancer patient
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140463


Contacts
Contact: Jeeyun Lee, MD +82-10-9933-1779 jyun.lee@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 99999
Contact: Jeeyun Lee, MD         
Principal Investigator: jeeyun Lee, professor         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Study Chair: Won Ki Kang, MD Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

Responsible Party: Jeeyun Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02140463     History of Changes
Other Study ID Numbers: 2013-11-014
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Urogenital Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases