Multicenter Validation of the Salivary miRNA Signature of Endometriosis

Launched by ZIWIG · Feb 16, 2022

Keywords

ClinConnect Summary

This clinical trial, called the ENDOmiARN Salive Test, is focused on finding a way to diagnose endometriosis, a condition that affects women and can cause pelvic pain and other symptoms. Researchers are testing a special test that looks for specific markers in saliva to help identify whether a woman has endometriosis. The goal is to make it easier and faster for women to get diagnosed, so they can receive the right treatment sooner.

To participate in this study, women aged 18 to 43 who have been diagnosed with endometriosis or are suspected of having it may be eligible. Participants will be asked to provide a saliva sample and answer some questionnaires, but their regular medical care will not change. This means their doctors will continue to provide treatment as usual. It’s important to note that certain women, such as those with specific types of endometriosis or certain health issues, may not be eligible to join the study. Overall, this trial aims to improve the way endometriosis is diagnosed and treated, enhancing care for many women.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Patient aged between 18 and 43 years,
• • Patient having dated and signed the consent form,
• • Patient affiliated to the French health system,
• • Patient with pelvic MRI and/or pelvic ultrasound,
• * Patient from one of the 3 study populations:
• • Patient with a formal endometriosis diagnosed by clinical examination and imaging AND an indication for specialised endometriosis follow-up or medically assisted procreation (MAP) or surgery validated by RCP (in routine care);
• • Patient with suspected endometriosis for whom the diagnosis is the source of a discrepancy between clinical and radiological data AND a surgical indication validated by RCP (in routine care);
• • Patient with a gynaecological indication for surgery of the small pelvis by laparoscopy or laparoscopy validated in RCP (in routine care) AND symptoms suggestive of endometriosis (dysmenorrhoea, ....)(1).
• Exclusion Criteria:
• • Patient with recurrence of deep endometriosis (excluding endometrioma),
• • Patient with endometriosis of the torus and/or utero-sacral ligaments without indication for surgery,
• • Patient with parietal endometriosis alone without indication for surgery,
• • Patient with adenomyosis alone on imaging without indication for surgery,
• • Patient with gynaecological infection requiring surgical management,
• • Pregnant patient,
• • Patient infected with the human immunodeficiency virus (HIV),
• • Patient with significant difficulties in reading or writing the French language,
• • Patient with a personal history of cancer,
• • Patient unable to comply with study and/or follow-up procedures,
• • Patient who has objected to the collection of her data.
• • Patient participating in another clinical research study.