NCT01845753

Brief Summary

A clinically applicably strategy for molecular screening for Lynch Syndrome is being implemented in 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

2.3 years

First QC Date

April 30, 2013

Last Update Submit

January 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of Lynch Syndrome in a population of primary colorectal cancer

    1 year

Study Arms (1)

All colorectal cancer patients

Other: Observation

Interventions

Observation

All colorectal cancer patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All colorectal cancer patients in Denmark

You may qualify if:

  • Histological diagnosis of colorectal adenocarcinoma
  • Diagnosed at one of the departments of pathology in Denmark

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Department of Pathology

Aalborg, Denmark

Location

Department of Clinical Genetics

Aarhus, Denmark

Location

Department of Pathology

Aarhus, Denmark

Location

Department of Pathology

Esbjerg, Denmark

Location

Department of Pathology

Hjørring, Denmark

Location

Department of Clinical Genetics

Odense, Denmark

Location

Department of Pathology

Odense, Denmark

Location

Department of Pathology

Sønderborg, Denmark

Location

Vejle Hospital

Vejle, 7100, Denmark

Location

Department of Clinical Genetics

Vejle, Denmark

Location

Department of Pathology

Vejle, Denmark

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColorectal Neoplasms, Hereditary Nonpolyposis

Interventions

Observation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2013

First Posted

May 3, 2013

Study Start

October 1, 2012

Primary Completion

February 1, 2015

Study Completion

December 31, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations