SarcomaNCT01831609
Biomarker Analysis of Solid Cancers Such as Gastrointestinal Cancer
An observational study of Sarcoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To prospectively collect ascites, pleural fluid, circulating tumor cells and derived primary cultures from metastatic cancer patients. The specimens will be analyzed using DNA/RNA/proteomic approaches. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Aug 2011to Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Patients with histologically confirmed gastrointestinal, genitourinary, sarcoma, rare cancer
Who may be able to join
- Patients with histologically confirmed gastrointestinal, genitourinary, sarcoma, rare cancer
- Written informed consent
- body fluid derived from cancer, available for drainage and collection
Who cannot join
- patients who do not give informed consent form for research use of biomaterials/biospecimens
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Hyejin Jang, RN, 822-3410-6859
About this study
To prospectively collect ascites, pleural fluid, circulating tumor cells and derived primary cultures from metastatic cancer patients. The specimens will be analyzed using DNA/RNA/proteomic approaches.
- Conditions
- Sarcoma
- Keywords
- Gastrointestinal, Genitourinary, Rare Cancer
- Medical subject headings
- Sarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker analyses to predict treatment response in metastatic cancer
Using patient derived tumor cells, predictive biomarker analyses (DNA, RNA protein levels etc) will be assessed.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study start31 Aug 2011
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyun Lee, Samsung Medical Center
- Investigators
- Jeeyun Lee, professor, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831609
- Sponsor's protocol ID
- 2011-07-089-013
- Status last verified
- Jun 2022
- First submitted
- 7 Apr 2013
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
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
- Biomarker Analysis of Solid Cancers Such as Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT01831609
- Acronym / sponsor ID
- 2011-07-089-013
- Conditions
- Sarcoma
- Keywords
- Gastrointestinal, Genitourinary, Rare Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 31 Aug 2011 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Apr 2013 (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.
To prospectively collect ascites, pleural fluid, circulating tumor cells and derived primary cultures from metastatic cancer patients. The specimens will be analyzed using DNA/RNA/proteomic approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Patients with histologically confirmed gastrointestinal, genitourinary, sarcoma, rare cancer
Key inclusion criteria (3 listed)
- Patients with histologically confirmed gastrointestinal, genitourinary, sarcoma, rare cancer
- Written informed consent
- body fluid derived from cancer, available for drainage and collection
Key exclusion criteria (1 listed)
- patients who do not give informed consent form for research use of biomaterials/biospecimens
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
Biomarker analyses to predict treatment response in metastatic cancer
Time frame: 3 year
Using patient derived tumor cells, predictive biomarker analyses (DNA, RNA protein levels etc) will be assessed.
Results and safety
Results are not available in the source record.
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.
Jeeyun Lee, professor principal investigator
Samsung Medical Center
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 Sarcoma, 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 3 inclusion and 1 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeeyun Lee, MD (822-3410-3459, jyun.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker analyses to predict treatment response in metastatic cancer (time frame: 3 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.