Malignant TumorNCT01458704
Cancer Genome Analysis
An observational study of Malignant Tumor, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Next generation sequencing (including targeted gene seqeuncing, exome and transcriptome sequencing) will be performed from fresh frozen tumor samples to understand the genetic alteration of tumors and to aid in optimal selection of further therapeutic agents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumor
- What is being tested?
- next generation sequencing
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Apr 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with malignant tumor receiving or planning to receive chemotherapy with fresh frozen tumor tissue with informed consent
Who may be able to join
- patients with malignant tumor
- receiving or planning to receive chemotherapy
- with fresh frozen tumor tissue
- with informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Tae-You Kim contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Tae-You Kim, 82-2-2072-2228, kimty@snu.ac.kr
About this study
Next generation sequencing (including targeted gene seqeuncing, exome and transcriptome sequencing) will be performed from fresh frozen tumor samples to understand the genetic alteration of tumors and to aid in optimal selection of further therapeutic agents.
- Conditions
- Malignant Tumor
- Being tested
- next generation sequencing
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
next generation sequencingOther
next generation sequencing (including targeted gene sequencing, exome sequencing, transcriptome sequenicing)
| Study group | Role | What they receive |
|---|---|---|
| fresh frozen tumor tissue | patients providing fresh frozen tumor tissue Receives: Other: next generation sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
targeted sequencing of cancer-relate genes
Identification and characterization of genetic alteration in cancer tissue
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tae-You Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458704
- Sponsor's protocol ID
- Cancer genome analysis
- Status last verified
- Oct 2011
- First submitted
- 23 Oct 2011
- Last updated
- 25 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Genome Analysis
- ClinicalTrials.gov ID
- NCT01458704
- Acronym / sponsor ID
- Cancer genome analysis
- Conditions
- Malignant Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2013 (estimated)
- First posted
- 25 Oct 2011 (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.
Next generation sequencing (including targeted gene seqeuncing, exome and transcriptome sequencing) will be performed from fresh frozen tumor samples to understand the genetic alteration of tumors and to aid in optimal selection of further therapeutic agents.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fresh frozen tumor tissue | – | Other: next generation sequencingpatients providing fresh frozen tumor tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with malignant tumor receiving or planning to receive chemotherapy with fresh frozen tumor tissue with informed consent
Key inclusion criteria (4 listed)
- patients with malignant tumor
- receiving or planning to receive chemotherapy
- with fresh frozen tumor tissue
- with informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| next generation sequencingnext generation sequencing (including targeted gene sequencing, exome sequencing, transcriptome sequenicing) | Other | fresh frozen tumor tissue |
Primary outcome
targeted sequencing of cancer-relate genes
Time frame: 1 year
Identification and characterization of genetic alteration in cancer tissue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2011.
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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.
Tae-You Kim contact
Tae-You Kim principal investigator
Seoul National University Hospital
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 Malignant Tumor, run by Seoul National University Hospital 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 0 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 25 Oct 2011. 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 Tae-You Kim (82-2-2072-2228), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
targeted sequencing of cancer-relate genes (time frame: 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 25 Oct 2011.