Colonic NeoplasmsNCT00516230
Establishing Effective Screening Methods for Diagnosing Hereditary Nonpolypoisis Colorectal Cancer
An observational study of Colonic Neoplasms, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Correct identification of Lynch syndrome at the time of colorectal cancer presentation is important. We aim to find best ways to screen patients with colorectal cancer in Korea. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colonic Neoplasms
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2006to Dec 2011
- 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
Who may be able to join
- Colorectal cancer
Who cannot join
- Histology showing other than adenocarcinoma
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam-gu, 135-710
Tae Kyun Kim, +82-2-3410-2975, tggo.kim@samsung.com
About this study
Correct identification of Lynch syndrome at the time of colorectal cancer presentation is important. We aim to find best ways to screen patients with colorectal cancer in Korea.
Read the detailed description
Patients with newly diagnoised colorectal cancer will be eligible. They will undergo detailed history taking including family history, and molecular stuidies including microsatellite instability test and immunohistochemistry for DNA mismatch repair protein with pre-selection. Any abnormal finding in molecular stuides will be offered genetic testing (after testing methylation status for patients with abnormalities in MLH1).
- Conditions
- Colonic Neoplasms
- Keywords
- Colonic Neoplasms, Lynch syndrome
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startJan 2006
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Dong Kyung Chang, M.D. Ph.D, Principal investigator, Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516230
- Sponsor's protocol ID
- SMC-2007-04-080
- Status last verified
- Aug 2007
- First submitted
- 13 Aug 2007
- Last updated
- 15 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Effective Screening Methods for Diagnosing Hereditary Nonpolypoisis Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00516230
- Acronym / sponsor ID
- SMC-2007-04-080
- Conditions
- Colonic Neoplasms
- Keywords
- Colonic Neoplasms, Lynch syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Dec 2011 (estimated)
- First posted
- 15 Aug 2007 (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.
Correct identification of Lynch syndrome at the time of colorectal cancer presentation is important. We aim to find best ways to screen patients with colorectal cancer in Korea.
Detailed description
Patients with newly diagnoised colorectal cancer will be eligible. They will undergo detailed history taking including family history, and molecular stuidies including microsatellite instability test and immunohistochemistry for DNA mismatch repair protein with pre-selection. Any abnormal finding in molecular stuides will be offered genetic testing (after testing methylation status for patients with abnormalities in MLH1).
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Colorectal cancer
Key exclusion criteria (1 listed)
- Histology showing other than adenocarcinoma
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2007.
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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.
Dong Kyung Chang, M.D. Ph.D principal investigator
Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
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 Colonic Neoplasms, 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 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 Aug 2007. 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 Dong Kyung Chang, M.D. Ph.D (+82-2-3410-3409, dkchang@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 Aug 2007.