Metastatic Gastrointestinal CancerNCT02140463
Next Generation pErsonalized tX(Therapy) With Plasma DNA Trial-2 in Refractory Solid Tumors (The NEXT-2 Trial)
An observational study of Metastatic Gastrointestinal Cancer and Genitourinary Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metastatic Gastrointestinal Cancer, Genitourinary Cancer
- How many people
- 229 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to 29 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: pathologically confirmed cancer patient
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Same as above
- Medical subject headings
- Gastrointestinal Neoplasms, Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| metastatic cancer | metastatic gastrointestinal cancer metastatic genitourinary cancer other rare cancer lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility
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.
Measured: 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 (6)
progression free survival (PFS),
The progression free survival (PFS), duration of response and overall survival of patients with refractory solid tumors.
Measured: 1years
molecular profile with cell-free DNA
To compare the correlation between primary/metastatic tumor formalin-fixed paraffin-embedded DNA molecular profile with cell-free DNA from plasma
Measured: 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
To evaluate changes in the tumor's molecular profile on serial cfDNA samples when patients progress after an initial response to targeted treatment
Measured: 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
The progression free survival (PFS), duration of response and overall survival of patients with refractory solid tumors.
Measured: 1years
overall survival
The progression free survival (PFS), duration of response and overall survival of patients with refractory solid tumors.
Measured: 1years
response rate
The response rate of molecular-profile directed treatments in refractory solid tumors
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2019
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyun Lee, Samsung Medical Center
- Investigators
- Won Ki Kang, MD, Study chair, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140463
- Sponsor's protocol ID
- 2013-11-014
- Status last verified
- Jun 2022
- First submitted
- 10 Feb 2014
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next Generation pErsonalized tX(Therapy) With Plasma DNA Trial-2 in Refractory Solid Tumors (The NEXT-2 Trial)
- ClinicalTrials.gov ID
- NCT02140463
- Acronym / sponsor ID
- 2013-11-014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metastatic cancer | – | –metastatic gastrointestinal cancer metastatic genitourinary cancer other rare cancer lung cancer |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pathologically confirmed cancer patient
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
progression free survival (PFS),
Time frame: 1years
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 ]
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 ]
Duration of response
Time frame: 1years
overall survival
Time frame: 1years
response rate
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Ki Kang, MD study chair
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Gastrointestinal Cancer and Genitourinary Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 ]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022; AzTrials last refreshed its copy on 31 Oct 2026.