Why Join the FORTE Study? 

45 to 70-year-old people who have had 1-2 small benign polyps (non-cancerous tissue growths) removed from their colon.

FORTE study is trying to determine the best surveillance colonoscopy interval. 

The usual approach for patients who are not in a study and who have had 1-2 benign polyps removed is to have a repeat colonoscopy in 5 to 10 years.

To be eligible for the FORTE study, participants must be considered low risk for colorectal cancer and have only one or two non-advanced polyps. Participants will be randomized to repeat colonoscopy at 5 and at 10 years vs. 10 years.

This colonoscopy schedule is for routine surveillance. If a patient were to develop symptoms or concerns, they would be able to get a colonoscopy for clinical care when they need it.

If you choose to take part in this study, there is a risk that you could develop colorectal cancer during the study.This could happen in either of the study groups to which you may be assigned.It is not known if the risk of colorectal cancer is reduced in people who have a colonoscopy at 5 and 10 years compared to 10 years.There is a risk you could develop colorectal cancer whether you participate in the study.

There are risks to having more frequent colonoscopy exams.The following are possible unexpected complications of having a colonoscopy.These risks could occur whether or not you are participating in this study but the likelihood of experiencing these complications may increase with more frequent colonoscopy exams.

• Belly pain
• Bleeding in the large bowel
• Complications due to anesthesia, including problems with your heart or breathing
• Hole in the large bowel or rectum, possibly requiring surgery

It is not possible to know now whether a repeat colonoscopy exam at 10 years will prevent colorectal cancer as well as a repeat colonoscopy at 5 years and 10 years. This study will help doctors learn to better help people in the future.

Your participation in the primary aim of the study will end after you undergo the colonoscopy exam at 10 years and the information about your 10-year colonoscopy is obtained from your medical records.  You will be contacted for up to 30 years after you join the study.  Your doctors may also be contacted for up to 30 years after you join the study to obtain copies of your colonoscopy reports or medical records.  Contacts after your colonoscopy exam at 10 years will be used to obtain long-term medical information and outcomes.  The contact for up to 30 years is to allow long-term follow-up of your medical outcomes.

No. Taking part in this study is voluntary. You are free to choose to participate or not to participate. If you choose to participate in this study, you can leave the study at any time.

You and/or your insurance company will need to pay for the costs of the medical care you get as a part of the study, which includes the colonoscopy exams, just as you would if you were not participating in the study. You will not be paid to take part in this study.

Before you decide to be in the study, you should check with your health plan or insurance company to find out exactly what they will pay for. 

If you decide not to take part in this study, your doctor will discuss other surveillance colonoscopy options with you.

Your privacy is very important to the study researchers and biobank. They will make every effort to protect it. Here are just a few of the steps they will take: They will remove identifiers, such as your initials, from your sample and information.

• They will replace them with a code number. There will be a master list linking the code numbers to names, but they will keep it separate from the samples and information.
• Researchers who study your sample and information will not know who you are. They also must agree that they will not try to find out who you are.
• Your personal information will not be given to anyone unless it is required by law.
• If research results are published, your name and other personal information will not be used.

Doctors and researchers conduct a clinical study, also called a “clinical trial,” to find better ways to prevent, diagnose, or treat an illness. NRG Oncology is supported by the National Cancer Institute (NCI) and runs clinical studies specifically for patients with cancer or to prevent cancer. Most clinical studies test something we know against something we don’t know. In all situations, these studies are strictly evaluated before they are allowed to be offered to any patient. The study is designed to answer the question that we do not know the answer to, so that current and future patients may have better treatments or information than what we currently have. There are different types of clinical studies that might be available for patients. For more information see “Types of Clinical Trials” and “Phases of Clinical Trials”.

Patients who volunteer to take part in a clinical study are followed closely by their health care professionals and members of the research team. For more information see “Research Team Members”.

Yes. They are exactly the same thing.

The care cancer doctors provide to cancer patients today is the direct result of clinical studies (also known as clinical trials) that were done in the past. Clinical studies give doctors and the treatment team information about what types of treatments work and what treatments do not work, in a number of different situations. Some studies focus on treating the cancer, others on preventing the cancer, and others on helping patients feel better or healthier during or after treatments. When you take part in a clinical study, you add to our knowledge about cancer and it may help improve cancer care for future patients. Clinical studies are available to patients with many types of cancer and at all stages of treatment. In some situations, the only way to get these new treatments is by joining a clinical study.

A clinical study may take place in many locations, such as:

A study is typically led by a principal investigator who is a doctor or other advanced health care professional. A clinical study is carried out by following a very specific plan known as the “protocol”. The protocol is designed so all patients in the study are treated as well as possible and in the same way. The protocol also provides rules for the doctors and clinical study staff to follow to keep patients safe and make sure the study is run in an ethical manner.

No, not at all. Participation in a clinical study is completely voluntary. For more information see “Deciding to Take Part in a Clinical Trial”. You are free to choose to participate or not to participate. If you choose to participate in a study, you may still decide to leave the study at any time. If you decide not to participate in a study, your doctor will discuss other treatment options with you. For more information see “Questions to Ask Your Doctor about Treatment Clinical Trials“.

• You may choose to have the usual treatment approach (known as “standard of care”)
• You may choose to take part or learn more about a different study, if one is available
• You may choose not to be treated for cancer