Metastatic Breast CancerNCT04258735
Genetic Characteristics of Metastatic Breast Cancer Patients
A study testing Genomic analysis in people with Metastatic Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Genomic analysis for metastatic breast cancer(MBC) patients Participant (Inclusion criteria) 1. Patients who diagnosed metastatic/stage IV breast cancer 2. Patients who were not received treatment for metastatic breast cancer on palliative setting Process (1) Tissue/ Blood sample At diagnosis, MBC tissue / blood… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Genomic analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jul 2019to 31 Jul 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who diagnosed ad metastatic breast cancer
- Patients who were not received treatment on palliative setting
Who cannot join
- Patients who did not agree this study
- Patients who did not have any pathologic specimen at MBC diagnosis.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710
Young-Hyuck Im, MD, PhD, +82-2-3410-3445, yh00.im@samsung.com
About this study
Genomic analysis for metastatic breast cancer(MBC) patients
- Participant (Inclusion criteria)
- Patients who diagnosed metastatic/stage IV breast cancer
- Patients who were not received treatment for metastatic breast cancer on palliative setting
- Process (1) Tissue/ Blood sample
- At diagnosis, MBC tissue / blood sample (20cc) will be obtained.
- At disease progression after 1st line treatment for MBC, blood sample (20cc) will be obtained (tissue; optional) (2) WES, RNASeq, ctDNA, Exosome
- We will analyze genomic characteritics using WES, RNASeq, ctDNA, Exosome.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Genomic analysis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genomic analysisDiagnostic test
WES, RNASeq, ctDNA, Exosome
| Study group | Role | What they receive |
|---|---|---|
| Metastatic breast cancer cohort | Other | Metastatic breast cancer with genetic tests including WES, RNASeq, ctDNA and exosome Receives: Diagnostic Test: Genomic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic profiling of MBC patients
Gemetic alteration frequency, the association between genetic alteration and survival
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start17 Jul 2019
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Hyuck Im, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258735
- Sponsor's protocol ID
- 2019-05-157
- Status last verified
- Feb 2020
- First submitted
- 23 Jul 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Characteristics of Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04258735
- Acronym / sponsor ID
- 2019-05-157
- Conditions
- Metastatic Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 6 Feb 2020 (actual)
- 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.
Genomic analysis for metastatic breast cancer(MBC) patients
- Participant (Inclusion criteria)
- Patients who diagnosed metastatic/stage IV breast cancer
- Patients who were not received treatment for metastatic breast cancer on palliative setting
- Process (1) Tissue/ Blood sample
- At diagnosis, MBC tissue / blood sample (20cc) will be obtained.
- At disease progression after 1st line treatment for MBC, blood sample (20cc) will be obtained (tissue; optional) (2) WES, RNASeq, ctDNA, Exosome
- We will analyze genomic characteritics using WES, RNASeq, ctDNA, Exosome.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic breast cancer cohort | Other | Diagnostic Test: Genomic analysisMetastatic breast cancer with genetic tests including WES, RNASeq, ctDNA and exosome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who diagnosed ad metastatic breast cancer
- Patients who were not received treatment on palliative setting
Key exclusion criteria (2 listed)
- Patients who did not agree this study
- Patients who did not have any pathologic specimen at MBC diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genomic analysisWES, RNASeq, ctDNA, Exosome | Diagnostic test | Metastatic breast cancer cohort |
Primary outcome
Genomic profiling of MBC patients
Time frame: 60 months
Gemetic alteration frequency, the association between genetic alteration and survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genomic analysis in people with Metastatic Breast 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 2 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: status not confirmed, as of the sponsor's last update on 6 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young-Hyuck Im, MD,PhD (82-2-3410-3459, yh00.im@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic profiling of MBC patients (time frame: 60 months). 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 6 Feb 2020.