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Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology

This international study, called GynRAN, is looking for new ways to diagnose common gynaecological conditions. Researchers are taking saliva samples from women who are having surgery for conditions like endometriosis, ovarian cysts, uterine fibroids, or gynaecological cancers. They are specifically looking at tiny genetic markers called RNA in the saliva to see if they can find a unique pattern or 'signature' that points to a specific condition. This is a "non-interventional" study, meaning that taking part will not change your planned medical care or treatments. The goal is to develop simpler, less invasive tests for these conditions in the future.

At a glance

Status
Recruiting
Sponsor
ZIWIG
Enrolment target
2,500
Start
05 Dec 2024
Estimated completion
01 Dec 2026

What is this study about?

Imagine being able to help doctors diagnose gynaecological conditions like endometriosis or certain cancers with a simple spit test. That's exactly what the GynRAN study is trying to achieve. This research is collecting saliva samples from women who are already scheduled for gynaecological surgery. They are doing this to find tiny pieces of genetic material, called RNA, in the saliva.

Researchers believe that these RNA pieces might hold important clues, acting like a unique fingerprint for different gynaecological problems – from common conditions like ovarian cysts and fibroids to more serious ones like ovarian, cervical, or uterine cancer. By studying these 'fingerprints', they hope to develop better ways to detect these conditions in the future, potentially making diagnosis earlier and less uncomfortable for patients.

It's important to know that taking part in this study won't change your medical care or any treatments you're already receiving. Your doctors will continue to manage your health exactly as they planned, following the standard recommended care for your condition. This study simply adds the collection of a saliva sample to help advance medical understanding.

Key takeaways

  • This study uses saliva to look for new ways to diagnose gynaecological conditions.
  • It covers common issues like endometriosis and ovarian cysts, and gynaecological cancers.
  • Participation involves providing a simple saliva sample and does not change your medical care.
  • The goal is to develop future diagnostic tests that are less invasive.
  • You must be 18 or older and meet specific health criteria to be eligible.

Who may be eligible?

You might be able to take part if you are an adult woman, aged 18 or over. You need to be insured for medical care and understand and sign a consent form.

You could be eligible if you are having symptoms (like bleeding or pain) and are scheduled for surgery or a biopsy for conditions such as endometriosis, ovarian cysts, fibroids, or cancers of the ovary, cervix, or womb. You might also be included if you don't have symptoms but have had an abnormal cervical screening test (Pap smear) or if you are having a routine cervical screening as part of your gynaecological check-up. The key is that you haven't yet had surgery or other treatments like chemotherapy or radiotherapy for these conditions.

There are also some reasons why you might not be able to join. These include having a recent infection, active mouth or digestive fungal infections, certain ongoing mouth problems, being pregnant, or having other non-gynaecological problems in your pelvis. If you have a different type of cancer (other than some skin cancers) or have been treated for cancer in the last five years, you won't be able to join. Also, if you have difficulty reading or writing, or are already part of another drug trial, 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.

  1. Are you 18 years old or older?
  2. Are you scheduled for gynaecological surgery or a biopsy for a condition like endometriosis, cysts, fibroids, or gynaecological cancer?
  3. Have you NOT already started chemotherapy or radiotherapy, or had surgery for your gynaecological condition?
  4. Are you generally well, without recent infections or certain mouth problems?
  5. Are you able to understand and sign a consent form for the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part, your involvement will be very straightforward. You will be asked to provide a saliva sample. This happens during a routine visit you are already making to your gynaecology or gynaecological oncology department, often when you are scheduled for surgery or a biopsy. Importantly, participation will not change your planned medical care, specialist appointments, or any treatments your doctor has recommended. Your care pathway remains exactly the same. There are no additional medications, extra doctor visits, or follow-up procedures specifically for this study. The total duration of your participation is essentially limited to the time it takes to provide the saliva sample.

Potential risks and benefits

The potential benefits of taking part in this study are indirect. Your contribution will help researchers develop better, potentially less invasive diagnostic tests for gynaecological conditions in the future, which could benefit many women. Since this study only involves providing a saliva sample and doesn't change your medical care, the risks to you are very low, mainly involving the minor inconvenience of collecting the sample. There are no known risks from the saliva collection itself. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (13)

  • CHU d'Angers
    Verified postcode
    Angers, France· Not yet recruiting
  • Clinique Tivoli Ducos - IFEMENDO
    Verified postcode
    Bordeaux, France· Recruiting
  • Institut Bergonié
    Verified postcode
    Bordeaux, France· Not yet recruiting
  • CHU Caen
    Verified postcode
    Caen, France· Recruiting
  • CGFL
    Verified postcode
    Dijon, France· Not yet recruiting
  • CHU Lyon Sud
    Verified postcode
    Lyon, France· Not yet recruiting
  • American Hospital of Paris
    Verified postcode
    Neuilly-sur-Seine, France· Not yet recruiting
  • CHU de Rennes Site Hôpital Sud
    Verified postcode
    Rennes, France· Not yet recruiting
  • Clinique La sagesse
    Verified postcode
    Rennes, France· Not yet recruiting
  • CHU Rouen
    Verified postcode
    Rouen, France· Recruiting
  • Clinique Pasteur
    Verified postcode
    Toulouse, France· Recruiting
  • CHU Bretonneau-Tours
    Verified postcode
    Tours, France· Recruiting

Common questions

What is RNA and why are you looking for it in saliva?

RNA is like a messenger that carries instructions inside our cells. Researchers believe different gynaecological conditions might leave unique RNA 'messages' in saliva, which could help diagnose them without invasive procedures.

Will taking part change my medical treatment?

No, absolutely not. Your doctors will continue to provide the best care for you based on your condition, just as they planned. This study will not change any of your appointments, treatments, or surgery.

What kind of gynaecological conditions are you studying?

We are looking at common conditions like endometriosis, ovarian cysts, and fibroids, as well as cancers of the ovary, cervix, and womb. The aim is to find diagnostic patterns for all of these.

Is the saliva collection painful or difficult?

No, collecting a saliva sample is usually very simple and not painful at all. It typically involves spitting into a small container.

Who is funding this research?

The study does not specify funding sources, but it is an international, multi-centre study aiming to advance gynaecological diagnostics.

How to find out more

Sofiane Bendifallah, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluation of Salivary RNA in Subjects Scheduled for Surgery…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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