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Colonoscopy for Colorectal Cancer (NordICC Trial)
Phase 3
Waitlist Available
Led By Michal Filip Kaminski, MD PhD
Research Sponsored by Oslo University Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years after screening (interim analysis after 10 years)
Awards & highlights
NordICC Trial Summary
This trial is investigating the effect of colonoscopy on colorectal cancer incidence and mortality.
Who is the study for?
This trial is for individuals aged 55-64 living in certain Northern-European countries, who haven't had colorectal surgery or cancer treatments recently. People with severe heart or lung disease, those needing constant care, or on lifelong Warfarin can't join.Check my eligibility
What is being tested?
The study tests if a one-time colonoscopy can reduce the incidence and mortality of colorectal cancer. Participants are randomly chosen to either receive a colonoscopy or no screening (usual care) and followed for up to 15 years.See study design
What are the potential side effects?
Colonoscopy may cause discomfort, bleeding where a lesion is removed, and rare complications like bowel perforation. Most people recover quickly without any serious issues.
NordICC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years after screening (interim analysis after 10 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years after screening (interim analysis after 10 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison of the screening group vs. the control group in an intention-to-treat model after 15 years of follow-up with regard to CRC mortality and CRC incidence
Secondary outcome measures
CRC mortality and CRC incidence of screening attendees compared to the control group and non-attendees
Mortality from all causes
NordICC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Colonoscopy screeningExperimental Treatment1 Intervention
One-time colonoscopy is the screening tool used in this trial. All individuals in the screening group will be offered a full colonoscopy. At colonoscopy, all detected CRC precursor lesions will be removed, whenever possible.
Group II: ControlActive Control1 Intervention
The control group will not be offered any screening or intervention within the trial, but follow usual care in the participating countries. Individuals assigned to the control group will not be informed about their status as controls in the trial. This approach facilitates a truly population-based study, which will be used to estimate the effect of the screening intervention in the general population, mimicking national CRC screening programs.
All ethics committees at the participating centres have approved the study protocol before recruiting individuals to the trial. In Sweden, the national ethics committee particularly reviewed the non-information of the control group and found it ethically acceptable.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colonoscopy
2012
Completed Phase 3
~115560
Find a Location
Who is running the clinical trial?
Oslo University HospitalLead Sponsor
1,069 Previous Clinical Trials
1,199,288 Total Patients Enrolled
Maria Sklodowska-Curie National Research Institute of OncologyOTHER
73 Previous Clinical Trials
83,140 Total Patients Enrolled
Erasmus Medical CenterOTHER
647 Previous Clinical Trials
1,778,516 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving chemotherapy or radiotherapy for cancer.You do not live in the country where the clinical trial is taking place.I am between 55 and 64 years old and live in the screening area.I have had surgery for colorectal issues before.I am on a lifelong Warfarin treatment.I have not had a stroke or similar brain event in the last 3 months.I do not have severe long-term heart or lung disease.I was hospitalized for a heart problem in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Colonoscopy screening
- Group 2: Control
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it risky to have a Colonoscopy?
"There is pre-existing clinical data that supports the Colonoscopy's safety, so it received a score of 3."
Answered by AI
Which type of patient is best suited for this particular clinical trial?
"95000 individuals aged 55-64, who have been diagnosed with colorectal cancer, are being enrolled in this clinical trial. Furthermore, these patients must reside in the screening areas and be randomly assigned to the screening group or control group. Housemates will be assigned to the same group (household randomisation).."
Answered by AI
Are elderly patients eligible for this therapy?
"This particular clinical trial is only for patients aged 55 to 64. There are other trials, 39 in total, for patients who are under 18. And, for patients 65 and older, there are 1084 trials."
Answered by AI
Recent research and studies
American Journal of GastroenterologyJournal
ACG Clinical Guidelines: Colorectal Cancer Screening 2021Other Trials to Consider
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