RecruitingNAINTERVENTIONAL

Detection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy

This exciting study aims to help women with ovarian cancer who have a specific genetic change called a BRCA mutation. These women are receiving a type of treatment called a PARP inhibitor, which helps prevent the cancer from coming back. We want to see if we can find very small changes in their blood, specifically in what's called 'circulating tumour DNA,' that might tell us if the cancer is starting to regrow, even before other signs appear. By identifying these changes early, doctors could potentially monitor patients more closely and adjust care if needed. This involves taking a few blood samples over time to look for these gene changes, while patients continue their standard treatment and check-ups.

At a glance

Status

Recruiting

Phase

Sponsor

Institut Claudius Regaud

Enrolment target

130

Start

08 Jan 2025

Estimated completion

01 Nov 2029

Ovarian Cancer

What is this study about?

This study is looking at ovarian cancer in women who have a specific genetic change called a BRCA1 or BRCA2 mutation. These mutations mean their bodies have trouble repairing damaged cells, which can increase the risk of certain cancers, including ovarian cancer. After initial treatment, these patients often receive a medication called a PARP inhibitor (like Olaparib), sometimes with another drug called bevacizumab. This maintenance treatment helps to keep the cancer from returning.

The main idea behind this study is to see if we can detect early signs of the cancer coming back by looking for specific genetic changes in the patient's blood. When cancer cells break down, they release tiny bits of their DNA into the bloodstream, which is called 'circulating tumour DNA.' We are specifically looking for changes in this DNA that might signal the cancer is starting to bypass the effects of the PARP inhibitor. If we can find these changes early, it might help doctors to know if a patient needs closer monitoring or different treatment plans sooner.

Ultimately, this research could lead to better ways of keeping a close eye on ovarian cancer patients, potentially helping doctors to make more informed decisions about their ongoing care. By understanding these genetic changes, we hope to improve how we manage treatment and follow-up for women with BRCA-mutated ovarian cancer.

Key takeaways

This study focuses on women with BRCA-mutated ovarian cancer.
It aims to detect early signs of cancer returning through blood tests.
Participants will already be receiving standard PARP inhibitor treatment (Olaparib).
Extra blood samples will be taken over two years, alongside regular check-ups.
The research could lead to improved monitoring for future ovarian cancer patients.

Who may be eligible?

To be part of this study, you need to be a woman aged 18 or over who has been diagnosed with either ovarian cancer, fallopian tube cancer, or a type of cancer that starts in the lining of the abdomen (primitive peritoneum). A key requirement is that you must have a confirmed BRCA1 or BRCA2 genetic mutation. You also need to be just starting your first maintenance treatment with Olaparib (either alone or with bevacizumab).

There are also some health and practical requirements. You should be generally well enough to take part in a study, as assessed by your doctor (this is called a 'WHO performance status' of 1 or less). You also need to be able to give your informed consent, meaning you understand the study and agree to participate. For this particular study, patients must also be registered with a social security scheme in France, as this is where the study is primarily taking place.

However, you cannot join if you have another ongoing cancer that is being treated, or if you've already started taking Olaparib. If you have any medical conditions that would make it unsafe to take blood samples, or if you have personal circumstances that would make it very difficult to attend appointments and follow the study rules, you wouldn't be able to participate. Also, individuals who are detained or legally protected wouldn't be eligible.

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 18 years old or older?
Do you have ovarian, fallopian tube, or primitive peritoneum cancer?
Do you have a confirmed BRCA1 or BRCA2 gene mutation?
Are you about to start Olaparib treatment for the first time?
Are you generally well and fit enough for daily activities?
Are you able to provide informed consent and attend appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you'll be asked to do that's different from your usual care is provide blood samples. These samples will be taken nine times over a two-year period, with about 36ml of blood (around two and a half tablespoons) taken each time. These blood draws will happen at the same time as your regular hospital visits, so it shouldn't require extra trips.

Apart from these blood samples, all your medical examinations, your treatment with Olaparib (or Olaparib with bevacizumab), and your follow-up appointments will be exactly the same as what you would receive as standard care for your condition. The study doesn't change your planned treatment in any way. You'll be part of the study for a total of 24 months, meaning two years, during which we'll collect the blood samples and monitor your progress as usual.

Potential risks and benefits

Taking part in this study might not directly benefit you, as the main goal is to learn more for future patients. However, by providing blood samples, you are playing an important role in advancing our understanding of ovarian cancer. There are no direct medical risks from the study itself, beyond the minor discomfort or bruising from blood draws, which are a routine medical procedure. You are free to withdraw from the study at any time without giving a reason, and this decision will not affect your ongoing medical care or relationship with your doctor.

Locations (6)

INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Angers
Verified postcode
Angers, France· Recruiting
Institut Bergonie
Verified postcode
Bordeaux, France· Recruiting
Chu de Limoges
Verified postcode
Limoges, France· Recruiting
Chu de Nimes
Verified postcode
Nîmes, France· Recruiting
INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Saint-Herblain
Verified postcode
Saint-Herblain, France· Recruiting
IUCT-O
Verified postcode
Toulouse, France· Recruiting

Common questions

What is a BRCA mutation?

BRCA1 and BRCA2 are genes that normally help repair damaged DNA. If they have a 'mutation' (a change), they don't work as well, which can increase the risk of certain cancers, like ovarian cancer.

What is a PARP inhibitor like Olaparib?

PARP inhibitors are medications designed to stop cancer cells with BRCA mutations from repairing themselves, leading to their death. They are often used as maintenance treatment to help keep cancer from returning.

What is circulating tumour DNA?

Circulating tumour DNA (ctDNA) refers to tiny fragments of DNA released by cancer cells into the bloodstream. Scientists can detect these fragments and look for specific changes.

Will taking part change my cancer treatment?

No, your cancer treatment with Olaparib (and bevacizumab if applicable), as well as all your follow-up care, will continue exactly as your doctor has planned. The study only involves extra blood samples.

How many blood samples will be taken?

You will have nine blood samples taken over the two years you are in the study, usually at the same time as your regular appointments.

How to find out more

Laurence GLADIEFF

gladieff.laurence@iuct-oncopole.fr 05 31 15 51 01 Official trial record

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