Active not recruitingOBSERVATIONAL

Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

The PROPHETIC study is looking into how our bodies react to cancer treatments. Specifically, it involves people in the UK with advanced lung cancer or melanoma. Researchers will collect blood samples both before and during their cancer treatment. By thoroughly examining these blood samples, the study aims to create a special tool. This tool is designed to help predict how likely a patient is to benefit from their specific cancer treatment. Doctors could then use this information to make more informed decisions about the best care plan for each individual. The study also hopes to discover new ways to improve future treatments.

At a glance

Status

Active not recruiting

Sponsor

OncoHost Ltd.

Enrolment target

10,000

Start

01 Oct 2019

Estimated completion

01 Oct 2029

Stage IV Non-small Cell Lung Cancer Stage IV Malignant Melanoma Stage IV Small Cell Lung Cancer Stage III Unresectable Non-Small Cell Lung Cancer Stage IIIb-d Malignant Melanoma

What is this study about?

This research study, called PROPHETIC, is about understanding how certain cancers respond to treatment. It focuses on people with advanced lung cancer (non-small cell and small cell lung cancer) and melanoma (a type of skin cancer) that has spread.

The main goal is to create a special computer program, or 'algorithm', that can predict how well a person's cancer treatment will work for them. To do this, researchers will look closely at changes in blood samples collected from patients. These changes, known as 'proteomic profiles', can give clues about how the body is reacting to the treatment. By understanding these reactions better, doctors might be able to choose the most effective treatments for each person, making their care more personal and potentially more successful.

Ultimately, this study hopes to give doctors a new tool to guide treatment choices for people with these specific advanced cancers. It could also lead to new discoveries about how cancer treatments affect the body, potentially opening doors to even better therapies in the future. Patients in the study will receive their usual cancer treatment according to their hospital's standard care.

Key takeaways

This study helps develop a tool to predict how well cancer treatments might work.
It involves people with advanced lung cancer or melanoma.
Taking part means giving two blood samples and sharing existing medical data.
Your cancer treatment will follow your doctor's usual recommendations.
The research aims to improve future treatment choices for patients.

Who may be eligible?

To take part in this study, you need to be at least 18 years old. You must also be able to understand the study and agree to participate by signing a consent form. Your general health needs to be reasonably good, meaning your blood tests for things like blood count, kidney function, and liver function should be within a healthy range.

The study is for people with specific types of advanced cancer: Stage IV non-small cell lung cancer, Stage IV malignant melanoma, Stage IV small cell lung cancer, or Stage III unresectable non-small cell lung cancer, or Stage IIIb-d malignant melanoma. For most of these cancers, doctors need to be able to measure your cancer to see how it's responding to treatment.

There are also some reasons why you might not be able to join. For instance, if you have another active cancer that required treatment in the last two years, you might not be eligible. Also, if a medical professional believes you can't fully understand what's involved in the study, you wouldn't be able to participate.

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 at least 18 years old?
Do you have Stage IV non-small cell lung cancer, Stage IV malignant melanoma, Stage IV small cell lung cancer, Stage III unresectable non-small cell lung cancer, or Stage IIIb-d malignant melanoma?
Are your routine blood test results (for blood count, liver, and kidney function) generally healthy?
Are you able to provide informed consent and understand the study requirements?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to receive your standard cancer treatment as prescribed by your doctor. The main additional step for you will be to provide two blood samples. One sample will be collected before you start your treatment, and the second will be taken at some point during your treatment period. The research team will also collect some of your medical information from your existing health records. There are no study medications involved; your treatment will be exactly what your doctor would normally recommend. The total duration of your participation will depend on when the blood samples are collected in relation to your course of treatment.

Potential risks and benefits

The potential benefit of taking part in this study is contributing to research that could help doctors make better treatment decisions for future cancer patients, and potentially for yourself, by developing a tool to predict treatment success. The main risk involves the minor discomfort and very small risk of bruising or infection from blood draws, which are standard medical procedures. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (41)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Birmingham VAHCS
Verified postcode
Birmingham, United States
Mayo Clinic
Verified postcode
Jacksonville, United States
University of Miami
Verified postcode
Miami, United States
Florida Cancer Specialist and Research Institute
Verified postcode
Orlando, United States
Protean Biodiagnosics
Verified postcode
Orlando, United States
Northwest Community Healthcare
Verified postcode
Rolling Meadows, United States
Helen Nassif Community Cancer Center
Verified postcode
Cedar Rapids, United States
Rutgers Cancer Institute
Verified postcode
New Brunswick, United States
Roswell Park
Verified postcode
Buffalo, United States
West Clinic
Verified postcode
Germantown, United States
Michael E. Debakey VA Medical Center
Verified postcode
Houston, United States
151-Christus Health St. Michael
Verified postcode
Texarkana, United States

Common questions

What is the main goal of this study?

The study aims to create a tool to predict how well cancer treatments will work for patients with advanced lung cancer or melanoma.

What will I have to do if I join?

You will provide two blood samples (one before treatment and one during treatment) and allow researchers to use your existing medical information.

Will my treatment change in any way?

No, you will receive your usual, standard cancer treatment recommended by your doctor; the study does not involve new medications.

What type of cancer does this study focus on?

It focuses on advanced non-small cell lung cancer, small cell lung cancer, and malignant melanoma.

Will I get any results from my blood tests?

The blood tests are for research purposes to develop a prediction tool, and individual results will not typically be shared directly with participants.