Repository for Biospecimens From Pregnant Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 7,000
- 主要终点
- Biomarker levels
研究概览
简要总结
An essential part of clinical research is the availability and accessibility of human biospecimens for the identification of biomarkers, new treatments and measurement of response to therapy. Proteins, RNA and DNA can be extracted and studied as well. This is a critical first step in performing many fundamental molecular biology experiments. A variety of biospecimens are utilized for research including but not limited to normal and malignant tissues, blood, and other body fluids.
In order to obtain high-quality biospecimens, they must be acquired serially, stored according to current standards, and matched with clinical information for maximum value. As such, the investigators would like to create a repository of biospecimens collected from pregnant patients who are seen at Mount Sinai Hospital and other research hospitals in Toronto. Mount Sinai provides personnel and infrastructure to serve the largest (7500 births/year) and highest complex Maternity program in Ontario. Of the 7500 patients a year, at least 2500 are considered high risk pregnancies, where there's a possibility of preeclampsia, placenta accreta and a host of other complications. For this study, biological specimens - blood, cervical and placental samples - will be collected from these high-risk groups in order to better understand the causes of the underlying conditions.
详细描述
The study will be non-interventional and designed for prospective sample collection and concurrent analysis.
Primary Objective #1: The primary objective is to provide a mechanism for system-wide patient engagement for banking and sourcing high-quality biologic specimens including tissues and bodily fluids. The study will be initiated at 3 sites - Sunnybrook Health Sciences Centre, North York General Hospital and Mt.Sinai Hospital - in the hopes of creating a translational research environment where patient data and biospecimens can inform future clinical practice.
The aim is to do this by:
- Establishing a comprehensive, secure and de-identified registry/database that includes current and future cases at high risk for abnormal placentation and healthy controls for comparison with patient consent.
- Comparing cases of suspected abnormal placentation with a control group of women with no evidence of abnormal placentation.
Primary Objective #2: Feasibility study that aims to provide preliminary insights into the biological markers and processes associated with abnormal placentation. By comparing a larger control group to those experiencing abnormal placentation, the investigators seek to understand potential biomarker differences. This phase is explorative in nature and is designed to determine the viability of our research approach and generate preliminary data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Consenting pregnant adults (age 18-45 years) with known or suspected risk for abnormal placentation (Abnormal Placentation Group)
- •Consenting pregnant adults (age 18-45 years) with low-risk pregnancies (Control Group)
- •Singleton or multiple pregnancy
- •Ongoing clinical care at the participating sites, with delivery at the same institution.
排除标准
- 未提供
结局指标
主要结局
Biomarker levels
时间窗: 18 months
Biomarkers for disease will be quantified in biospecimens.
Pathology
时间窗: 9 months
From the database, the presence or absence of perinatal pathologies recorded in the patient's medical records will be determined. These data will be compared with biomarker levels to determine if they are correlated.
次要结局
未报告次要终点