Colorectal NeoplasmsNCT00220246
Clinical and Molecular Characterization of Familial Microsatellite Stable Colorectal Cancer
An observational study of Colorectal Neoplasms, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Two major genetic pathways leading to colorectal carcinoma can well be distinguished; the 'suppressor pathway', which is characterized by inactivation of tumor-suppressor genes and the 'mutator pathway', which is characterized by microsatellite instability. Read more about this study
- Who is it for?
- Ages Up to 51 years
- Conditions the study is for
- Colorectal Neoplasms
- How many people
- 130 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2004to Sep 2008
- 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 Up to 51 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Colorectal cancer before the age of 51 years
- Microsatellite stable tumor
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Two major genetic pathways leading to colorectal carcinoma can well be distinguished; the 'suppressor pathway', which is characterized by inactivation of tumor-suppressor genes and the 'mutator pathway', which is characterized by microsatellite instability. The purpose of this study is to explore a third putative pathway; microsatellite and chromosome stable colorectal cancer where an alternative cancer-causative mechanism might play a role.
Read the detailed description
Patients with familial colorectal cancer will be characterized with respect to family history, medical history and demographic characteristics. The histopathology of the tumors will be reviewed. Tumor specimens will be analysed on molecular defects.
- Conditions
- Colorectal Neoplasms
- Keywords
- Hereditary colorectal cancer, Microsatellite instability, Chromosomal instability
- Medical subject headings
- Colorectal Neoplasms, Microsatellite Instability, Chromosomal Instability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2004
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Radboud University 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
- Retrospective
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Nicoline Hoogerbrugge, MD, PhD, Principal investigator, Department of Human Genetics, Radboud University Nijmegen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220246
- Sponsor's protocol ID
- EOMSD2004
- Status last verified
- Feb 2007
- First submitted
- 20 Sep 2005
- Last updated
- 1 Mar 2007
- Results posted
- No
Publications
Chan TL, Curtis LC, Leung SY, Farrington SM, Ho JW, Chan AS, Lam PW, Tse CW, Dunlop MG, Wyllie AH, Yuen ST. Early-onset colorectal cancer with stable microsatellite DNA and near-diploid chromosomes. Oncogene. 2001 Aug 9;20(35):4871-6. doi: 10.1038/sj.onc.1204653.
PubMed 11521198Hawkins NJ, Tomlinson I, Meagher A, Ward RL. Microsatellite-stable diploid carcinoma: a biologically distinct and aggressive subset of sporadic colorectal cancer. Br J Cancer. 2001 Jan;84(2):232-6. doi: 10.1054/bjoc.2000.1554.
PubMed 11161382Georgiades IB, Curtis LJ, Morris RM, Bird CC, Wyllie AH. Heterogeneity studies identify a subset of sporadic colorectal cancers without evidence for chromosomal or microsatellite instability. Oncogene. 1999 Dec 23;18(56):7933-40. doi: 10.1038/sj.onc.1203368.
PubMed 10637503
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Characterization of Familial Microsatellite Stable Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00220246
- Acronym / sponsor ID
- EOMSD2004
- Conditions
- Colorectal Neoplasms
- Keywords
- Hereditary colorectal cancer, Microsatellite instability, Chromosomal instability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Sep 2008
- First posted
- 22 Sep 2005 (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.
Two major genetic pathways leading to colorectal carcinoma can well be distinguished; the 'suppressor pathway', which is characterized by inactivation of tumor-suppressor genes and the 'mutator pathway', which is characterized by microsatellite instability. The purpose of this study is to explore a third putative pathway; microsatellite and chromosome stable colorectal cancer where an alternative cancer-causative mechanism might play a role.
Detailed description
Patients with familial colorectal cancer will be characterized with respect to family history, medical history and demographic characteristics. The histopathology of the tumors will be reviewed. Tumor specimens will be analysed on molecular defects.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 51 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Colorectal cancer before the age of 51 years
- Microsatellite stable tumor
Key exclusion criteria (1 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
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 1 Mar 2007.
- Background: PubMed 11521198Chan TL, Curtis LC, Leung SY, Farrington SM, Ho JW, Chan AS, Lam PW, Tse CW, Dunlop MG, Wyllie AH, Yuen ST. Early-onset colorectal cancer with stable microsatellite DNA and near-diploid chromosomes. Oncogene. 2001 Aug 9;20(35):4871-6. doi: 10.1038/sj.onc.1204653.
- Background: PubMed 11161382Hawkins NJ, Tomlinson I, Meagher A, Ward RL. Microsatellite-stable diploid carcinoma: a biologically distinct and aggressive subset of sporadic colorectal cancer. Br J Cancer. 2001 Jan;84(2):232-6. doi: 10.1054/bjoc.2000.1554.
- Background: PubMed 10637503Georgiades IB, Curtis LJ, Morris RM, Bird CC, Wyllie AH. Heterogeneity studies identify a subset of sporadic colorectal cancers without evidence for chromosomal or microsatellite instability. Oncogene. 1999 Dec 23;18(56):7933-40. doi: 10.1038/sj.onc.1203368.
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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.
Nicoline Hoogerbrugge, MD, PhD principal investigator
Department of Human Genetics, Radboud University Nijmegen 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 Colorectal Neoplasms, run by Radboud University Medical Center at 1 site in Netherlands.
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 2 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 1 Mar 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 Netherlands. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00220246, which also lists 3 linked publications.
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 1 Mar 2007.