Gastric CancerNCT01470404
Pharmacogenomic Study (Adjuvant Chemotherapy)
An observational study of Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To assess the role of germline polymorphisms in xenobiotic metabolism genes in toxicity profile. To assess the role of germline polymorphisms in genes associated with DNA repair, p53 tumor suppressor gene and angiogenesis pathway in predicting recurrence and survival in gastric cancer patients treated with adjuvant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- How many people
- 792 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jul 2008to 10 Jul 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 enrolled on to the adjuvant trial will be considered as candidates for the study. Once the patient signed written informed consent, 10cc blood will be drawn in EDTA tube for DNA extraction.
Who may be able to join
- gastric cancer patients treated with adjuvant chemotherapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacogenomic Study to Predict Toxicity and Response in Gastric Cancer Patients Treated With Adjuvant Chemotherapy
To assess the role of germline polymorphisms in xenobiotic metabolism genes in toxicity profile.
To assess the role of germline polymorphisms in genes associated with DNA repair, p53 tumor suppressor gene and angiogenesis pathway in predicting recurrence and survival in gastric cancer patients treated with adjuvant chemotherapy.
- Conditions
- Gastric Cancer
- Medical subject headings
- Stomach 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 |
|---|---|---|
| adjuvant chemotherapy | Patients enrolled on to the adjuvant XP trial + patients who received adjuvant chemotherapy following curative resection of gastric cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
germline polymorphisms in xenobiotic metabolism genes in toxicity profile
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study start10 Jul 2008
- Primary completion10 May 2013
- Study completion10 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 792 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ki Kang, Samsung Medical Center
- Investigators
- won ki kang, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470404
- Sponsor's protocol ID
- 2008-05-053
- Status last verified
- Jan 2018
- First submitted
- 9 Nov 2011
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomic Study to Predict Toxicity and Response in Gastric Cancer Patients Treated With Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT01470404
- Acronym / sponsor ID
- 2008-05-053
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 792 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 10 Jul 2008 (actual)
- Primary completion
- 10 May 2013 (actual)
- Study completion
- 10 Jul 2013 (actual)
- First posted
- 11 Nov 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.
To assess the role of germline polymorphisms in xenobiotic metabolism genes in toxicity profile.
To assess the role of germline polymorphisms in genes associated with DNA repair, p53 tumor suppressor gene and angiogenesis pathway in predicting recurrence and survival in gastric cancer patients treated with adjuvant chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adjuvant chemotherapy | – | –Patients enrolled on to the adjuvant XP trial + patients who received adjuvant chemotherapy following curative resection of gastric cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled on to the adjuvant trial will be considered as candidates for the study. Once the patient signed written informed consent, 10cc blood will be drawn in EDTA tube for DNA extraction.
Key inclusion criteria (1 listed)
- gastric cancer patients treated with adjuvant chemotherapy
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.
Primary outcome
germline polymorphisms in xenobiotic metabolism genes in toxicity profile
Time frame: 36 months
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 17 Jan 2018.
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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 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 Gastric 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 1 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: finished, as of the sponsor's last update on 17 Jan 2018. 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?
germline polymorphisms in xenobiotic metabolism genes in toxicity profile (time frame: 36 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 17 Jan 2018.