RecruitingOBSERVATIONAL

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

The ORACLE study is investigating a new blood test designed to detect cancer recurring in people who have had early-stage solid tumours treated. This test, called Guardant Reveal, looks for tiny fragments of cancer DNA in the blood. The main goal is to show that this test can accurately tell when cancer might be coming back, which could help doctors monitor patients more effectively. Researchers want to understand how valuable this test could be in a healthcare setting where costs are carefully managed. By linking the test results to what actually happens with patients' health, the study hopes to prove the test's usefulness for finding cancer recurrence and guiding future medical decisions.

At a glance

Status

Recruiting

Sponsor

Guardant Health, Inc.

Enrolment target

2,020

Start

07 Sep 2021

Estimated completion

01 Aug 2029

Bladder Carcinoma Ureter Carcinoma Renal Pelvis Carcinoma Non-small Cell Lung Cancer Invasive Breast Carcinoma Cutaneous Melanoma Esophageal Carcinoma Gastroesophageal Junction Carcinoma Gastric Adenocarcinoma Pancreatic Adenocarcinoma Squamous Cell Carcinoma of the Head and Neck Epithelial Ovarian Carcinoma Fallopian Tube Carcinoma Endometrial Carcinoma Renal Cell Carcinoma Rectal Adenocarcinoma

What is this study about?

The ORACLE study is looking into a new way to check if cancer might return after someone has had treatment for an early-stage solid tumour. Many cancers can be successfully treated, but there's always a worry they might come back. Currently, doctors use regular check-ups and scans to keep an eye on things, but this new blood test could offer an earlier warning.

This new blood test works by looking for tiny bits of cancer's genetic material, called DNA, which can sometimes be found floating in the blood. If these bits of DNA are detected, it might signal that the cancer is trying to reappear, even before it's big enough to be seen on scans or cause symptoms. The study aims to see how good this test is at spotting these early signs and how it compares to the usual follow-up care.

The main purpose is to see if finding these DNA fragments can predict whether cancer will return and if this information can help doctors decide on the best next steps for their patients. The study also wants to understand if this test is a practical and cost-effective tool to use in the NHS, ultimately aiming to improve how we monitor people after cancer treatment.

Key takeaways

This study explores a new blood test to find out if cancer might return.
It's for people treated for certain early-stage solid tumours.
Participation involves giving blood samples during regular follow-up appointments.
The study aims to improve monitoring after cancer treatment.
Any personal health information will be kept private and anonymous.
You can stop participating at any time without affecting your care.

Who may be eligible?

To join this study, you need to be over 18 years old and have recently been treated for certain types of early-stage cancer with the aim of curing it. You also need to be planning to continue with your regular follow-up appointments and monitoring at your hospital.

The specific cancers included in this study are various stages of bladder, kidney, lung, breast, skin (melanoma), oesophagus, stomach, pancreas, head and neck, and ovarian cancers. Your doctor will be able to confirm if your specific cancer type and stage are part of the study requirements.

You would also need to be happy to provide blood samples regularly for up to five years and allow your anonymised health information to be shared for research, after giving your written consent.

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?
Have you been treated for certain early-stage cancers with the aim of a cure?
Are you having regular check-ups at the hospital for your cancer?
Are you willing to provide blood samples during your routine appointments?
Are you happy for your health information to be used anonymously for research?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would need to give various blood samples. The first sample would be taken when you join the study, and then more samples would be collected during your routine follow-up appointments at the hospital. This would continue for up to five years. The study will not involve any new medications or additional treatments beyond your usual care. The main commitment for you would be providing these blood samples and allowing the study team to collect information about your health from your medical records during your regular follow-up appointments.

Potential risks and benefits

Taking part in a study like this doesn't offer direct medical benefits to you right away, as the test is still being evaluated. However, your participation could help future patients by providing valuable information about early cancer detection. The main risks are minor, mostly related to giving blood samples, such as slight pain or bruising. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care or your relationship with your healthcare team.

Locations (57)

University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
Ironwood Cancer & Research Centers
Verified postcode
Chandler, United States· Recruiting
Genesis Cancer Center
Verified postcode
Hot Springs, United States· Terminated
University of California, San Diego
Verified postcode
La Jolla, United States· Recruiting
Hoag Memorial Hospital Presbyterian
Verified postcode
Newport Beach, United States· Recruiting
Redwood City
Verified postcode
Redwood City, United States· Recruiting
Sutter Institute for Medical Research
Verified postcode
Sacramento, United States· Terminated
University of Colorado
Verified postcode
Aurora, United States· Recruiting
Memorial Healthcare System
Verified postcode
Hollywood, United States· Recruiting
The Oncology Institute of Hope & Innovation
Verified postcode
Lakeland, United States· Recruiting
Tulane Cancer Center
Verified postcode
New Orleans, United States· Recruiting
Christus Highland/ Boniol
Verified postcode
Shreveport, United States· Recruiting

Common questions

What is ctDNA?

ctDNA stands for 'circulating tumour DNA'. It's tiny bits of genetic material from cancer cells that can be found in your bloodstream. This new test looks for these fragments.

Will taking part change my cancer treatment?

No, this study will not change your current cancer treatment or the regular follow-up care you receive from your doctors. It's about testing a new monitoring method alongside your usual care.

How long will I need to be in the study?

If you join, you would be involved in the study for up to five years, mainly by providing blood samples during your routine hospital visits.

Is this new blood test available to everyone?

No, this specific test is still being researched and is not yet available for general use. That's why this study is so important, to see if it works well.

What happens if the test finds cancer DNA in my blood?

The study is for research, so any results from the test will be used to understand its accuracy. It will not directly change your medical care during the study. Your doctors will continue to follow their standard procedures for your follow-up.

How to find out more

Clinical Trial Operations

mrdoraclestudy@guardanthealth.com 8556988887 Official trial record

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