UCLA Perinatal Biospecimen Repository
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|ClinicalTrials.gov Identifier: NCT05035160|
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : July 6, 2022
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.
|Condition or disease|
|Pregnancy High-Risk Pregnancy|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||UCLA Perinatal Biospecimen Repository|
|Actual Study Start Date :||July 30, 2021|
|Estimated Primary Completion Date :||July 30, 2026|
|Estimated Study Completion Date :||July 30, 2026|
Pregnant and postpartum birthing persons with perinatal pathology.
Healthy pregnant and postpartum birthing persons.
Healthy non-pregnant persons (healthy volunteers).
- Number of participants of the Perinatal Repository [ Time Frame: From July 30, 2021, to July 30, 2026. ]To establish the Perinatal Repository for collection, storage, and distribution of the human data and biospecimens of the participants with perinatal pathology
Biospecimen Retention: Samples With DNA
- Blood: whole blood, plasma, serum;
- Placenta samples: RNAlater, snap freeze, 70% Alcohol, FFPE;
- Umbilical cord: snap freeze, FFPE;
- POC: 70% Alcohol and FFPE;
- Cell Lines: HUVEC, trophoblastic, and other;
- Protein, RNA, DNA;
- Other biospecimens.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05035160
|Contact: Yalda Afshar, MD. PhD||(805) firstname.lastname@example.org|
|Contact: Anhyo Jeong, BS||(805) 679-3915||AnhyoJeong@mednet.ucla.edu|
|United States, California|
|Afshar Lab, Department of Obstetrics & Gynecology, UCLA||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Yalda Afshar, MD, PhD 805-338-5593 YAfshar@mednet.ucla.edu|
|Contact: Anhyo Jeong, BS (805) 679-3915 AnhyoJeong@mednet.ucla.edu|
|Principal Investigator:||Yalda Afshar, MD, PhD, MD. PHD||University of California, Los Angeles|