RecruitingOBSERVATIONAL

Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients

This study aims to understand if the types of bacteria in your gut (your microbiome) and certain markers in your blood, linked to autoimmune conditions, can help predict who might develop challenging side effects when treated with modern cancer drugs called immunotherapies. Researchers will collect stool and blood samples from up to 120 patients with advanced solid tumours receiving these treatments at Princess Margaret Cancer Centre. The goal is to identify early signs that someone might experience more severe side effects, which could lead to better ways to manage or even prevent them in the future. This is a "minimal risk" study, meaning it mainly involves analysing samples already being collected, without new treatments or extra hospital visits.

At a glance

Status

Recruiting

Sponsor

University Health Network, Toronto

Enrolment target

120

Start

05 Sep 2019

Estimated completion

05 Mar 2027

Solid Tumor

What is this study about?

This study is looking into how our bodies react to a type of modern cancer treatment called immunotherapy. Immunotherapy works by boosting your body's own immune system to fight cancer. While often very effective, these treatments can sometimes cause unexpected side effects, similar to autoimmune conditions where the immune system mistakenly attacks healthy parts of the body.

Scientists believe that the tiny germs living in our gut, known as the gut microbiome, might play a big role in how well immunotherapies work and whether side effects develop. They also want to see if specific markers in your blood, often seen in autoimmune diseases, could be linked to these side effects. By understanding these connections, doctors hope to get better at predicting who might experience side effects and develop ways to prevent or manage them more effectively. This could make immunotherapy safer and more tolerable for patients.

This is a research study where doctors will collect samples of your stool and blood at different times during your immunotherapy treatment. They're not testing new medications, but rather gathering information from samples to learn more. The aim is to find patterns that could help other patients in the future.

Key takeaways

This study looks at gut bacteria and blood markers in cancer patients.
It aims to predict side effects from immunotherapy treatments.
Participation involves providing blood and stool samples during your regular visits.
You won't receive new treatments or have extra hospital appointments for this study.
The findings could help improve immunotherapy safety for future patients.

Who may be eligible?

To join this study, you need to be over 18 years old and have an advanced solid tumour (cancer that started in an organ and has spread) that doctors believe can't be cured. You must be receiving immunotherapy combined with other treatments at Princess Margaret Cancer Centre and be willing to provide blood and stool samples.

There are also a few reasons you might not be able to join. For example, if you've had an autoimmune disease (where your immune system attacks your own body) that flared up within the last year, you wouldn't be eligible. Also, if your doctor thinks joining the study might put your health at risk or make it difficult to get accurate results, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 years old?
Do you have an advanced solid tumour?
Are you receiving immunotherapy combination treatment at Princess Margaret Cancer Centre?
Are you willing and able to provide blood and stool samples?
Have you had an autoimmune condition flare-up in the last year? (If yes, you may not be eligible).

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't have to make any extra visits to the hospital. All the samples (blood and stool) will be collected during your regular hospital appointments and clinic visits for your ongoing cancer treatment. You will be receiving your immunotherapy combination treatment as planned by your doctors for your cancer, either as part of another clinical trial or as routine care. The study mainly involves analysing these samples to see if there are any links between your gut bacteria, certain blood markers, and how your body reacts to the immunotherapy. The study plans to enrol up to 120 patients and collect samples at several points during their treatment.

Potential risks and benefits

This is considered a minimal risk study because it doesn't involve new treatments or any procedures beyond what you'd normally receive for your cancer care. The main participation involves providing blood and stool samples, which are generally safe procedures. While there are no direct medical benefits to you from participating in this specific study, the information gained could greatly help future cancer patients by leading to better ways to predict and manage side effects from immunotherapy. You are free to withdraw from the study at any time without affecting your ongoing medical care.

Locations (1)

Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What kind of cancer treatments are involved?

The study focuses on patients receiving a combination of modern cancer drugs called immunotherapies for advanced solid tumours.

Do I have to take any new medicines?

No, this study does not involve giving you any new medications or treatments. You will continue with your planned cancer treatment as usual.

What samples will be collected?

Researchers will collect samples of your blood and stool (poo) at different times during your treatment.

Will I have extra hospital visits for this study?

No, you will not need any extra hospital visits. Samples will be collected during your existing appointments for your cancer treatment.

What will the study hope to achieve?

The study hopes to find out if gut bacteria and certain blood markers can predict side effects from immunotherapy, which could help manage these side effects better in the future.

How to find out more

Anna Spreafico, MD

tip@uhn.ca 416-946-4501 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.