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Colonoscopy for Colorectal Cancer (NordICC Trial)

Phase 3

Waitlist Available

Led By Michael Bretthauer, 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

Must not have

On-going cytotoxic treatment or radiotherapy for malignant disease

Individuals with previous colorectal surgery (resections, enterostomies)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving chemotherapy or radiotherapy for cancer.

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I have had surgery for colorectal issues before.

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I am on a lifelong Warfarin treatment.

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I have not had a stroke or similar brain event in the last 3 months.

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I do not have severe long-term heart or lung disease.

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I was hospitalized for a heart problem in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

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.

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

0 / 6Eligibility criteria met