If you are considering participation in a clinical trial, here are answers to the most common questions. Where relevant, answers reflect the specific context of ECOPOP trials.
Safety and patient rights
Key topics: safety monitoring, consent, withdrawal, data protection.
Patient safety is the top priority in all clinical trials. Studies are strictly regulated, approved by independent ethics committees, and monitored throughout their duration. In ECOPOP trials, an independent safety board reviews study data and may recommend changes if safety concerns arise.
Your safety is monitored at multiple levels. The clinical team at your study centre follows your progress throughout the trial. In addition, an independent safety board reviews trial data and can recommend changes if needed.
All medical treatments may involve risks or side effects. In clinical trials, these are carefully assessed before the study begins and monitored throughout. You will receive detailed information about potential risks before deciding whether to participate.
Yes. Participation is entirely voluntary, and you can withdraw at any stage without consequences for your future care. Your treatment options outside the trial remain the same regardless of your decision.
Deciding not to participate will not affect the care you receive. You will continue to be offered appropriate standard treatment. Participation is always a free and informed choice.
Your condition is monitored throughout the study. If necessary, your treatment may be adjusted, or you may be withdrawn from the trial to ensure your safety and appropriate care.
Your data is anonymised and handled in accordance with strict data protection regulations, including GDPR. Only authorised personnel involved in the study have access to identifiable information.
Participation and process
What to expect before and during participation.
You can be referred by your treating doctor or contact a participating centre directly. Eligibility depends on specific medical criteria defined in the trial protocol. The clinical team will assess whether the study is appropriate for your situation.
Before joining any trial, you will receive detailed information about the study, including what it involves, which treatment options are being compared, and what the potential risks and benefits are. You will have time to consider this and ask questions. Participation begins only after you sign a consent form.
Yes. Clinical trials compare approaches that are considered appropriate based on current medical knowledge. In ECOPOP, trials compare current standard approaches with less intensive or organ-preserving strategies. The goal is to determine whether treatment burden can be safely reduced without compromising outcomes.
In randomised trials, participants are assigned to a treatment group through a controlled and unbiased process called randomisation. This helps clinical research produce reliable results. You will be told in advance how assignment works in the specific trial you are considering.
In ECOPOP trials, participants are informed which treatment they are receiving. These are open-label studies, meaning there is no concealment of treatment assignment.
ECOPOP trials compare recognised treatment strategies used in clinical care. Depending on the trial, this may include standard surgical treatment or a less invasive approach. You will not be assigned to a treatment considered inappropriate for your condition.
The duration depends on the specific trial. In ECOPOP studies, follow-up may continue for several years after treatment, with key assessments usually taking place in the first one to three years. The exact schedule will be explained before you give consent.
Costs and practical aspects
Financial and logistical questions.
Yes. Clinical trials are funded, and participation does not involve costs for patients. ECOPOP is funded by the European Union under the Horizon Europe programme.
In many cases, travel or accommodation costs associated with study visits may be reimbursed. This depends on the specific trial and study centre. The clinical team will clarify this before enrolment.
Trial-related procedures and visits take place at a participating study centre. However, the clinical team can coordinate with your regular healthcare providers to support continuity of care.
Clinical trials include scheduled visits and assessments to monitor safety and outcomes. These may be more frequent than in standard care, particularly in the first year. The full schedule will be explained before enrolment.
You will be asked to attend scheduled visits, follow the assigned treatment pathway, and report any symptoms or side effects to the clinical team. Informing the team about changes in your health helps ensure your safety and the reliability of the study results.
About ECOPOP trials specifically
Questions specific to the trials running within the ECOPOP project.
ECOPOP focuses on early-stage colorectal cancer, including T1 cancer. This means the tumour is limited to the inner layers of the bowel wall. In selected cases, this stage of disease may be suitable for less invasive treatment approaches.
Endoscopic treatment means removing a lesion from inside the bowel using a flexible instrument with a camera. This approach avoids a large surgical incision. The exact technique and type of anaesthesia depend on the specific procedure and study centre.
ECOPOP includes several trials for specific patient groups. ETHOS is for selected patients with early colon cancer. SCAR is for patients whose early colon cancer was found after incomplete or uncertain removal during colonoscopy. T-REX is for patients with early rectal cancer who have had local removal but have features associated with a higher risk of recurrence. Eligibility depends on your diagnosis, medical history, and trial criteria.
Some patients with early colorectal cancer may not need the full burden of more intensive treatment. However, this must be proven carefully. ECOPOP compares less invasive or organ-preserving strategies with current standard approaches to determine when treatment burden can be safely reduced.
If your question is not answered here, contact the ECOPOP coordination team directly.