Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers

Официальное название

Proof-of-Concept, Obs Study to Evaluate Accuracy of MetriDx Lab Developed Test (LDT) to Accurately Identify Endometriosis-specific Biological Markers Using Micro-fluidic Analysis of Cells Enabling Clinicians to Diagnose Endometriosis

Обзор

This study is testing a way to diagnose endometriosis using a uterine tissue biopsy (similar to a pap smear) as opposed to undergoing laparoscopy surgery. The tissue is sent to lab for cellular analysis with a proprietary AI (artificial intelligence) technology.

Подробное описание

This study involves 2 visits to the site and possibly as outpatient surgical center, and the participant will be involved in the for as little as 1 day to as much as 60 days, mainly depending on scheduling of laparoscopy. Eligible participants in the active group will have history of endometriosis and will be having a laparoscopy for diagnosis within the next few weeks. Eligible participants in the control group will have no history of endometriosis but will need or have recently had a laparoscopy surgical procedure for a reasons such as tubal ligation.

The participant will have an uterine biopsy (similar to a pap smear) in the physician's office before the laparoscopy. The biopsied tissue will be sent to a special lab for analysis and diagnosis of endometriosis by an innovative proprietary procedure that analyses the cells of the tissue collected in the biopsy.

The results of the biopsy will be compared to the laparoscopy for accuracy.

Вмешательства

• Диагностический тест MetriDx
  Biopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record

Первичные конечные точки

• Primary Outcome [Срок оценки: 1 week after laparoscopy]

Вторичные конечные точки (2)

• Secondary Outcome [Срок оценки: 1 week after laparoscopy]
• Tertiary Outcome [Срок оценки: 1 week after providing menstrual effluent sample]

Критерии участия

Критерии включения

• Able to understand and provide informed consent.
• Natural born female of childbearing potential.
• Age between 18 and 50, inclusive.
• Not pregnant at Visit 0 (screening) or Visit 1 (day of procedure).
• Free of systemic or pelvic disorder that, in the opinion of the investigator, may interfere with the tissue collection procedure, analysis of the tissue or increase the risk to subject.
• Must not have received excision or ablation surgical procedure or treatment, such as gonadotropin-releasing hormone (GnRH), for endometriosis within the past 12 months.
• For Cohort 1 and 2:

• Suspected of having endometriosis, or previously diagnosed with endometriosis, and currently recommended for laparoscopic surgery by physician.
• Must have laparoscopic surgery within 60 days after screening Visit 0 and any time after the endometrial biopsy is obtained on Visit 1 (including the same day), or a laparoscopy on record within the 12 months prior to Visit 0 for diagnosis only.
• Surgical report from prior laparoscopy must indicate that endometriosis was not treated with surgical ablation or excision.
• Subjects will be assigned to Cohort 1 or 2 based on diagnosis and staging results from laparoscopy.
• Or for Cohort 3:

• Not suspected of having endometriosis
• no previous diagnosis or symptoms of endometriosis, who have had a laparoscopy for another reason, such as tubal ligation or other abdominal procedure, within the past 12 months prior to screening Visit 0,
• or laparoscopy to be completed within 60 days after screening Visit 0 and any time after the endometrial biopsy is obtained on Visit 1 (including the same day).
• Surgeon's report must have no supplemental observations of endometriosis lesions or diagnosis. Subjects will be assigned to Cohort 3.

Критерии исключения

• Younger than 18 or 51 years or older.
• Surgical history of hysterectomy.
• Has received excision or ablation surgical procedure or treatment, such as gonadotropin-releasing hormone (GnRH), for endometriosis within the past 12 months.
• Cohort 3: Prior diagnosis of endometriosis, or surgical note from prior laparoscopy that indicates endometriosis lesions were observed.
• Has a BMI 40 or above.
• Is currently taking a blood thinner medication.
• Currently, pregnant, breast feeding, or has given birth in the last 6 months.
• Diagnosed with HIV, AIDS, hepatitis A, B, or C, or has active malignancy.
• Has a complicating condition that would pose a hazard to tissue handling.
• Undergoing fertility or hormone therapy treatments.
• History or evidence of uterine fibroids.
• History of reproductive cancer.
• Has a condition that, in the opinion of the investigator, would confound tissue collection or analysis.
• Has an active pelvic infection or other infections contra-indicated for laparoscopy.
• Has participated in any interventional clinical trial in the previous 90 days in which an investigational drug was administered.
• Has a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past two years.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

США · 3 центра

• Valley OB-GYN Clinic, PC — Saginaw
• Corpus Christi Women's Center — Corpus Christi
• University of Texas Physician's Women's Center--Memorial City — Houston

Идентификаторы

NCT: NCT05698212 · HER001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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