Набор по приглашению NCT06907303

RNA Assays for Endometriosis Detection and Diagnosis

— Наблюдательное Endometriosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: EndoDx.
Кому может быть актуально: Состояния в реестре: Endometriosis. Базовые параметры: 20 лет — 35 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, ЮАР
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Development and Evaluation of RNA-based Markers for Detecting and Diagnosing Endometriosis

Обзор

Endometriosis is a common disease that affects up to 10% of women of reproductive age. Diagnosis, however, is typically delayed (up to 12 years) and is usually made after surgery. A key unmet need therefore is an accurate biomarker that can be used to detect the disease early. This study is a prospective trial to identify candidate mRNA-markers which can be used to aid in the diagnosis of this disease. It is a discovery/validation study that will identify and confirm a gene expression panel that is specific for endometriosis and provides a non-invasive tool for future use.

Подробное описание

Endometriosis is a common disease that affects up to 10% of women of reproductive age. Diagnosis, however, is typically delayed (up to 12 years) and is typically made after surgery. A key unmet need therefore is an accurate, non-invasive biomarker that can be used to detect the disease early.

We hypothesize that endometriosis-related circulating gene expression can be identified using transcriptomic and bioinformatics approaches and used to construct an accurate diagnostic tool for this condition.

The primary objective is to develop a gene signature that detects endometriosis. The hypothesis is that this disease is characterized by a set of genes that characterize endometriosis tumor biology.

The aim is to detect over-expressed genes (elevated mRNA expression) in endometriosis tissue. The goal is to identify 10-25 biomarker genes that are highly expressed to form a candidate biomarker panel.

Highly expressed genes will be determined against samples collected from age/menstrual stage matched controls. A bio-informatics approach will be used to identify these over-expressed genes. This form the basis of a potential diagnostic panel.

Per PICOT criteria:

* The target patient population are women aged 20-35 years with a pathological diagnosis of endometriosis. * The intervention is sample collection at the time of diagnosis (tissue, blood, saliva) * The comparison group are normo-ovulatory subjects (age 20-25 years) undergoing surgery for benign cervical lesions. * The outcome is a gene signature that is associated with endometriosis. * The follow-up time is one year.

The secondary objective is to test the diagnostic utility of the 10-25 gene panel. This will be undertaken using the retrospectively collected samples.

* Each of the highly expressed genes will be measured and quantified using an RT-PCR approach. * Genes that are statistically over-expressed in the endometriosis samples will be selected for a PCR panel. * The expression of genes in the PCR panel will be scored. * Low scores will be related to "control" and higher scores to "endometriosis". * The scores will be formally evaluated as a diagnostic (area under the curve analysis, accuracy, sensitivity and specificity metrics). * A specific comparison will be made between the endometriosis cohort and the control cohort. * The metrics for a successful assay are:

* Accuracy \>80% * Sensitivity \>90% * Specificity \>85% * AUC \>0.8

Вмешательства

Диагностический тест EndoDx
PCR assay for Endometriosis diagnosis

Первичные конечные точки

Develop a gene signature that detects endometriosis [Срок оценки: 12-18 months]

Вторичные конечные точки (1)

Assess the diagnostic utility of the gene signature to differentiate between endometriosis and controls [Срок оценки: 6 months]

Критерии участия

Критерии включения

For the endometriosis cohort

a history of infertility more than 1 year
age 20-35 years
normal liver and kidney function, without gynaecological and other systemic disease

Inclusion criteria for controls include normo-ovulatory history, aged between 20-35 years, who exhibit normal liver and kidney function, and do not have any systemic diseases including autoimmune disease.

Критерии исключения

For the endometriosis cohort

polycystic ovary syndrome, hyperprolactinemia
severe cardiovascular system, liver, kidney, and hematopoietic system disease
autoimmune disease
uterine fibroids, endometritis, non-vegetative ovarian cysts, ovarian malignancies, and internal genital tuberculosis

Exclusion criteria for the controls includes gynaecological malignancies and genital tuberculosis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.