Colonoscopy for Colorectal Cancer

(NordICC Trial)

Not currently recruiting at 6 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Oslo University Hospital

Must not be taking: Cytotoxic, Radiotherapy, Warfarin

Disqualifiers: Colorectal surgery, Severe cardiac, Lung, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a colonoscopy (a procedure to examine the colon) can reduce the risk of developing or dying from colorectal cancer. Researchers are comparing two groups: one group undergoes a one-time colonoscopy to detect and remove early cancer signs, while the other group continues with regular healthcare without screening in the trial. The trial targets individuals aged 55-64 living in specific regions of Nordic countries, the Netherlands, or Poland, who have not undergone major bowel surgery or have serious health issues. The goal is to assess whether colonoscopies can significantly decrease cancer cases and deaths over time. As a Phase 3 trial, this study represents the final step before potential FDA approval, allowing participants to contribute to crucial research that could lead to widespread cancer prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on lifelong anticoagulant therapy with Warfarin, you would be excluded from participating.

What prior data suggests that colonoscopy is safe for colorectal cancer screening?

Research has shown that colonoscopy is generally safe. Studies have found it significantly lowers the risk of dying from colorectal cancer. For instance, one study found a 68% lower risk of death for those who underwent colonoscopy compared to those who did not. Another study demonstrated a 62% reduction in deaths from colon cancer after screening with colonoscopy.

Most people tolerate colonoscopy well. However, like any medical procedure, it can have side effects such as bloating, cramping, or bleeding. Serious complications are rare but can occur. Discussing potential risks with a healthcare provider is always important before deciding on any procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effectiveness of using a one-time colonoscopy as a screening tool for colorectal cancer (CRC). Unlike standard CRC screening methods, such as fecal tests or repeated colonoscopies, this approach focuses on a single, comprehensive examination. This could potentially simplify screening protocols and make early detection more accessible. By investigating its impact on the general population, this trial aims to mimic and enhance national CRC screening programs, ultimately hoping to improve early detection rates and outcomes.

What evidence suggests that colonoscopy is effective for colorectal cancer prevention?

Research has shown that colonoscopy can lower the risk of colorectal cancer. In this trial, participants in the colonoscopy screening arm will receive a one-time colonoscopy as the screening tool. One study found that individuals invited for a colonoscopy screening had a lower chance of developing colorectal cancer over 10 years. Another study demonstrated that colonoscopy screenings reduced new colorectal cancer cases by 40% and deaths by 52% compared to no screening. These findings suggest that colonoscopy effectively identifies and removes potential cancerous growths early, reducing cancer risk and death rates. This evidence supports the effectiveness of colonoscopy in preventing colorectal cancer. ^{3 5 6 7 8}

Who Is on the Research Team?

Hans-Olov Adami, MD PhD

Principal Investigator

Harvard School of Public Health, Boston, USA

Michael Bretthauer, MD PhD

Principal Investigator

Oslo University Hospital

Michal Filip Kaminski, MD PhD

Principal Investigator

Marie Cure Sklodowska Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 55 and 64 years old and live in the screening area.

Exclusion Criteria

Return of unopened letter of invitation and/or reminder (address unknown)

I am currently receiving chemotherapy or radiotherapy for cancer.

You do not live in the country where the clinical trial is taking place.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Not specified

1 visit (in-person)

Colonoscopy Screening

Participants in the screening group undergo a one-time colonoscopy to detect and remove CRC precursor lesions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for CRC incidence and mortality over a long-term period

15 years

Interim analysis at 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Colonoscopy

Trial Overview 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.

How Is the Trial Designed?

Group I: Colonoscopy screening Experimental Treatment 1 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: Control Active Control 1 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.

Colonoscopy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in United States as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in Canada as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in Japan as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in China as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in Switzerland as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Who Is Running the Clinical Trial?

Oslo University Hospital

Lead Sponsor

Trials

1,132

Recruited

7,856,000+

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborator

Trials

81

Recruited

179,000+

Erasmus Medical Center

Collaborator

Trials

742

Recruited

2,156,000+

Landspitali University Hospital

Collaborator

Trials

46

Recruited

467,000+

Uppsala University Hospital

Collaborator

Trials

188

Recruited

749,000+

Karolinska Institutet

Collaborator

Trials

1,510

Recruited

32,450,000+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials

1,998

Recruited

602,000+

Harvard School of Public Health (HSPH)

Collaborator

Trials

283

Recruited

17,030,000+

Published Research Related to This Trial

A structured assessment of 1,144 patients who underwent colonoscopy revealed that nearly 30% reported definite-related minor adverse events, and about 3% experienced major adverse events, indicating that post-procedural complications are more common than previously thought.

Patients who experienced definite-related adverse events were less likely to be willing to return for future colonoscopies and had a less positive overall experience, highlighting the importance of addressing these events to improve patient satisfaction and compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The incidence of 30-day adverse events after colonoscopy among outpatients in the Netherlands. de Jonge, V., Sint Nicolaas, J., van Baalen, O., et al.[2015]

In a study of 3121 asymptomatic veterans who underwent colonoscopy screening, adverse events occurred in only 2.8% of follow-up examinations, indicating that long-term colonoscopy screening is generally safe.

Serious cardiopulmonary events were the most common major complications, and a history of prior colonoscopic adverse events significantly increased the risk of future complications, suggesting the importance of assessing patients' medical histories before follow-up procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of colonoscopy adverse events in the prospective Cooperative Studies Program no. 380 colorectal cancer screening and surveillance cohort. Kobe, EA., Sullivan, BA., Qin, X., et al.[2023]

Colonoscopy is generally safe, with an adverse event rate of 2.8 per 1000 procedures, but serious complications like hemorrhage and perforation are more common when polypectomy is performed.

The article emphasizes the importance of preventing and managing adverse events specifically related to polypectomy and endoscopic mucosal resection of colonic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to colonic endoscopic mucosal resection and polypectomy. Sethi, A., Song, LM.[2022]

In a study of 161 patients with lower gastrointestinal bleeding (LGIB) and 161 matched non-GIB controls, adverse events during bowel preparation and colonoscopy were found to be low, indicating that colonoscopy is generally safe for LGIB patients.

There were no significant differences in adverse events between LGIB and non-GIB patients, even among subgroups such as the elderly or those with comorbidities, suggesting that colonoscopy does not increase risks in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events during Bowel Preparation and Colonoscopy in Patients with Acute Lower Gastrointestinal Bleeding Compared with Elective Non-Gastrointestinal Bleeding. Niikura, R., Nagata, N., Shimbo, T., et al.[2022]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815644

Effectiveness of Colonoscopy Screening vs Sigmoidoscopy ... This comparative effectiveness simulation study of 358 204 adults showed a statistically significant 7 percentage point reduction in colorectal cancer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10905314/

Effectiveness of Colonoscopy Screening vs Sigmoidoscopy ... This comparative effectiveness simulation study of 358 204 adults showed a statistically significant 7 percentage point reduction in colorectal cancer ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2208375

Effect of Colonoscopy Screening on Risks of Colorectal ... In this randomized trial, the risk of colorectal cancer at 10 years was lower among participants who were invited to undergo screening colonoscopy.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8138747/

Association of Screening Lower Endoscopy With ... Does screening still confer a benefit in reducing the risk of colorectal cancer (CRC) and related deaths in adults older than 75 years?

5. gastrojournal.org gastrojournal.org/article/S0016-5085(24)00293-2/fulltext

Comparative Effectiveness and Cost-Effectiveness of ... CMSmin reduced CRC incidence by 40% and CRC mortality by 52% vs no screening. These reductions were less profound than the 68%–79% and 73%–81%, respectively, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6701463/

LOWER ENDOSCOPY AND PREVENTION OF COLON ... Lower endoscopy was associated with reduced risk for CRC mortality by 68% for colonoscopy (adjusted hazard ratio [aHR], 0.32; 95% CI, 0.24–0.45) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7477408/

Colonoscopic screening is associated with reduced ... Our results showed that colonoscopy was associated with a 52% RR reduction in incidence of CRC (RR: 0.48, 95% CI: 0.46-0.49) and 62% RR reduction in mortality ...

8. giejournal.org giejournal.org/article/S0016-5107(24)03164-X/fulltext

Quality indicators for colonoscopy High-quality colonoscopy includes adequate bowel preparation, safe colonoscope insertion to the proximal extent of the colon, detailed ...