UCLA Perinatal Biospecimen Repository
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05035160|
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : July 6, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||1 Minute and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||
The study has no inclusion criteria based on gender, race, ethnicity, and language spoken. The protocol contains inclusion criteria for enrollment in the study associated with term "pregnancy/childbearing potential".
The nature of and scientific rationale for the inclusions:
This observational study will establish the new UCLA Perinatal Biospecimen Repository, to collect, storage and distribute the clinical data and biospecimens of the participants with perinatal pathology. Therefore, pregnant and postpartum birthing persons are the target population for this clinical protocol.
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
Ages Eligible for Study: Child, Adult Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Study Population: Any UCLA Health patient that is at risk for perinatal pathology.
Estimated Enrollment: 500 participants.
- 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).
- Pregnant and postpartum birthing person unwilling to give written informed consent to participate in the study.
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|
Documents provided by Yalda Afshar, MD, PhD, University of California, Los Angeles:
|Responsible Party:||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|
|Other Study ID Numbers:||
|First Posted:||September 5, 2021 Key Record Dates|
|Last Update Posted:||July 6, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
|Time Frame:||From July 30, 2021, to July 30, 2026.|
|Access Criteria:||Distribution rules and criteria used to determine the adequacy of investigators' requests to acquire the Material from the Repository are set forth in the "UCLA Perinatal Biospecimen Repository Advisory Committee" Policy and "Request Form for the UCLA Perinatal Biospecimen Repository Advisory Committee".|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|