Colorectal CancerNCT01216930
Molecular Screening for Lynch Syndrome in Southern Denmark
An observational study of Colorectal Cancer and Lynch Syndrome, run by Vejle Hospital at 7 sites in Denmark.
Trial summary
A clinically applicably strategy for molecular screening for Lynch Syndrome has been implemented in the Region of Southern Denmark. Based on sequential analysis with immunohistochemistry and methylation analysis, patients with possible hereditary colorectal cancer are identified. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer, Lynch Syndrome, HNPCC
- What is being tested?
- Observation
- How many people
- 2,000 participants
- Where
- 7 sitesDenmark
- Study dates
- Oct 2010to Sep 2015
- 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
Study population: All colorectal cancer patients in the geographical region of southern Denmark
Who may be able to join
- Histological diagnosis of colorectal adenocarcinoma
- Diagnosed at one of the five departments of pathology in the region
Who cannot join
- None
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Department of Pathology
Esbjerg
Department of Clinical Genetics
Odense
Department of Pathology
Odense
Department of Pathology
Sønderborg
Department of Pahology
Svendborg
Department of Clinical Genetics
Vejle
Department of Pathology
Vejle
About this study
A clinically applicably strategy for molecular screening for Lynch Syndrome has been implemented in the Region of Southern Denmark.
Based on sequential analysis with immunohistochemistry and methylation analysis, patients with possible hereditary colorectal cancer are identified. These patients are offered genetic risk assessment and counselling.
The study hypothesis is that molecular screening will identify more patients with Lynch Syndrome than the family history alone.
Prospective data collection is performed using established clinical databases.
- Conditions
- Colorectal Cancer, Lynch Syndrome, HNPCC
- Being tested
- Observation
- Medical subject headings
- Colorectal Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation
| Study group | Role | What they receive |
|---|---|---|
| All colorectal cancer patients | Not described Receives: Other: Observation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216930
- Sponsor's protocol ID
- MS-LS-DK-01
- Other IDs
- 10-5156
- Status last verified
- Sep 2015
- First submitted
- 6 Oct 2010
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Screening for Lynch Syndrome in Southern Denmark
- ClinicalTrials.gov ID
- NCT01216930
- Acronym / sponsor ID
- MS-LS-DK-01
- Conditions
- Colorectal Cancer, Lynch Syndrome, HNPCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Oct 2010 (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.
A clinically applicably strategy for molecular screening for Lynch Syndrome has been implemented in the Region of Southern Denmark.
Based on sequential analysis with immunohistochemistry and methylation analysis, patients with possible hereditary colorectal cancer are identified. These patients are offered genetic risk assessment and counselling.
The study hypothesis is that molecular screening will identify more patients with Lynch Syndrome than the family history alone.
Prospective data collection is performed using established clinical databases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All colorectal cancer patients | – | Other: Observation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All colorectal cancer patients in the geographical region of southern Denmark
Key inclusion criteria (2 listed)
- Histological diagnosis of colorectal adenocarcinoma
- Diagnosed at one of the five departments of pathology in the region
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ObservationObservation | Other | All colorectal cancer patients |
Primary outcome
Not reported in the source record.
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 14 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Lynch Syndrome, run by Vejle Hospital at 7 sites in Denmark.
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: finished, as of the sponsor's last update on 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. 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.
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 14 Sep 2015.