UCLA Perinatal Biospecimen Repository
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Number of participants of the Perinatal Repository
研究概览
简要总结
The purpose of this investigator-initiated prospective observational cohort study is to establish the new UCLA Perinatal Biospecimen Repository (Perinatal Repository) for collection, storage, and distribution of the human data and biospecimens of the participants with perinatal pathology. The secure and shared high-quality resource of clinical data and biological specimens (Repository Materials), across pregnancy pathology related to research protocols at the Afshar's Lab will be created. Core variables of interest include clinical characteristics and relevant biological samples. Intention to collect perinatal data is aiding the efficiency and effectiveness of de-identified biorepository for pregnancy-at-risk outcome research.
The primary aims of the project are:
- To design the Case Report Forms (CRFs) for the clinical and biospecimen data.
- To create and update the project-specific policies, agreements, and Standard Operating Procedures (SOPs).
- To develop the data management system to assure personal health information de-identification, data integrity, participants welfare, and protocol compliance.
- To develop and implement a quality management system for the Repository.
- To collect and record in the Repository protocol-related clinical information.
- To organize a consistent system to bank high-quality biospecimens while protecting participant-donor safety and privacy.
- To establish the policies and procedures for Repository Materials dissemination and research collaboration.
- To analyze the scientific results of the Repository creation. The secondary aim of the study is to provide a mechanism to store and share for research purposes the de-identified biospecimen and information about participants at risk for adverse pregnancy outcomes.
详细描述
Duration of the project - 5 years. The approximate number of participants - 1000. The number of visits - from one to 6. Duration of the subject's participation in the study - from 1 day to 12 months. Follow-up period: from enrollment to postpartum visit. Core variables of interest comprise the birthing person's/ fetus'/ neonate's clinical characteristics and relevant biological samples: maternal blood, cord blood, plasma, serum, urine, breastmilk, placenta, umbilical cord, amniotic fluid, the product of conception (POC), and cell lines. Collection and retaining of the biospecimens will be performed by the study team across perinatal pathology cases at the UCLA Health Medical Centers for up to 15 years.
Biospecimens will be collected prospectively to the Perinatal Repository. Clinical data will be linked to the biospecimens.
Participation in the Repository Protocol can be offered by the PI/ designee for the outpatients and inpatients. Eligibility criteria will be checked during the baseline visit. The informed consent form should be signed at enrolment, following which baseline medical history will be collected. Procedures and assessments will be performed according to the routine standard at UCLA Health, and are documented as available (with the exception of Informed Consent).
Enrolment/ Baseline Visit: After consenting, the birthing person will be asked to donate blood (maternal blood) or/ and urine specimen to the Repository. Trained research team personnel will collect the biospecimens per standard operating procedures. The study protocol provides for the collection of blood samples as a procedure combined with routine blood sampling for clinical laboratory testing.
For research purposes, it is intended to collect a small additional amount of the venous maternal blood - less than 10 mL per procedure. The blood will not be drawn for research more often than twice in a single week. Blood draws will be performed as follow: Red Top Tube (Serology tube) - at least 10 mL and Lavender Top Tube (EDTA tube) - at least 10 mL. Blood samples will be collected for whole blood, plasma, and serum banking.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant and postpartum birthing persons aged 18 and over with perinatal pathology;
- •Healthy pregnant and postpartum birthing persons;
- •Healthy non-pregnant birthing persons (healthy volunteers).
排除标准
- •Pregnant and postpartum birthing person unwilling to give written informed consent to participate in the study.
结局指标
主要结局
Number of participants of the Perinatal Repository
时间窗: From July 30, 2021, to December 31, 2028
To establish the Perinatal Repository for collection, storage, and distribution of the human data and biospecimens of the participants with perinatal pathology
次要结局
未报告次要终点
研究者
Yalda Afshar, MD, PhD
MD, PhD, Lab Director, Assistant Professor, UCLA, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology
University of California, Los Angeles