Curatively Resected Stage III Colon CancerNCT00977717
Pharmacogenomic Study to Predict Neurotoxicity of Oxaliplatin
An observational study of Curatively Resected Stage III Colon Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In order to explore genetic factors that may determine the neurotoxicity of oxaliplatin-based chemotherapy, germinal gene polymorphisms will be analyzed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Curatively Resected Stage III Colon Cancer
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to Apr 2010
- 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: Curatively resected stage III colon cancer
Who may be able to join
- aged 18 or older
- curatively resected colon adenocarcinoma
- pathologically staged III
- adequate performance status
- adequate major organ functions
- to be treated with adjuvant FOLFOX chemotherapy
- written informed consent
Who cannot join
- those who disagree the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacogenomic Study to Predict Toxicity and Response in Colorectal Cancer Patients Treated With Oxaliplatin-based Chemotherapy
In order to explore genetic factors that may determine the neurotoxicity of oxaliplatin-based chemotherapy, germinal gene polymorphisms will be analyzed.
Read the detailed description
To investigate the impact of single nucleotide (SNP) polymorphism on the toxicity profile in colorectal cancer patients treated with FOLFOX chemotherapy, 10 cc of blood will be drawn in EDTA tube for extraction. DNA will be extracted from peripheral blood samples using DNA isolation kit, and SNP polymorphisms will be evaluated.
- Keywords
- oxaliplatin, neuropathy, SNPs
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 |
|---|---|---|
| FOLFOX | Stage III colorectal cancer patients who are treated with adjuvant FOLFOX chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuropathy
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startSep 2008
- Primary completionJan 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Curatively Resected Stage III Colon 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Se Hoon Park, MD, Principal investigator, Samsung Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977717
- Sponsor's protocol ID
- 2008-05-052
- Status last verified
- Apr 2010
- First submitted
- 3 Sep 2009
- Last updated
- 19 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Baek KK, Lee J, Park SH, Park JO, Park YS, Lim HY, Kang WK, Cho YB, Yun SH, Kim HC, Lee WY, Chun HK. Oxaliplatin-induced chronic peripheral neurotoxicity: a prospective analysis in patients with colorectal cancer. Cancer Res Treat. 2010 Dec;42(4):185-90. doi: 10.4143/crt.2010.42.4.185. Epub 2010 Dec 31.
PubMed 21253319
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomic Study to Predict Toxicity and Response in Colorectal Cancer Patients Treated With Oxaliplatin-based Chemotherapy
- ClinicalTrials.gov ID
- NCT00977717
- Acronym / sponsor ID
- 2008-05-052
- Keywords
- oxaliplatin, neuropathy, SNPs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 16 Sep 2009 (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.
In order to explore genetic factors that may determine the neurotoxicity of oxaliplatin-based chemotherapy, germinal gene polymorphisms will be analyzed.
Detailed description
To investigate the impact of single nucleotide (SNP) polymorphism on the toxicity profile in colorectal cancer patients treated with FOLFOX chemotherapy, 10 cc of blood will be drawn in EDTA tube for extraction. DNA will be extracted from peripheral blood samples using DNA isolation kit, and SNP polymorphisms will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFOX | – | –Stage III colorectal cancer patients who are treated with adjuvant FOLFOX chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Curatively resected stage III colon cancer
Key inclusion criteria (7 listed)
- aged 18 or older
- curatively resected colon adenocarcinoma
- pathologically staged III
- adequate performance status
- adequate major organ functions
Key exclusion criteria (1 listed)
- those who disagree the study
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
neuropathy
Time frame: six 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 19 Apr 2010.
- Derived from this study: PubMed 21253319Baek KK, Lee J, Park SH, Park JO, Park YS, Lim HY, Kang WK, Cho YB, Yun SH, Kim HC, Lee WY, Chun HK. Oxaliplatin-induced chronic peripheral neurotoxicity: a prospective analysis in patients with colorectal cancer. Cancer Res Treat. 2010 Dec;42(4):185-90. doi: 10.4143/crt.2010.42.4.185. Epub 2010 Dec 31.
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.
Se Hoon Park, MD principal investigator
Samsung Medical Center, 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 Curatively Resected Stage III Colon 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 7 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: finished, as of the sponsor's last update on 19 Apr 2010. 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?
neuropathy (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00977717, which also lists 1 linked publication.
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 19 Apr 2010.