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UCLA Perinatal Biospecimen Repository

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ClinicalTrials.gov Identifier: NCT05035160
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : September 5, 2021
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Yalda Afshar, MD, PhD, University of California, Los Angeles

Brief Summary:

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
Group 1
Pregnant and postpartum birthing persons with perinatal pathology.
Group 2
Healthy pregnant and postpartum birthing persons.
Group 3
Healthy non-pregnant persons (healthy volunteers).



Primary Outcome Measures :
  1. 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;
  • Breastmilk;
  • Urine;
  • Other biospecimens.


Information from the National Library of Medicine

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Ages Eligible for Study:   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
Study Population

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.

Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Pregnant and postpartum birthing person unwilling to give written informed consent to participate in the study.

Information from the National Library of Medicine

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


Contacts
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Contact: Yalda Afshar, MD, PhD 310-794-7274 yafshar@mednet.ucla.edu
Contact: Irina Gontschar, MD, PhD, ACRP-CCRP 310-794-7274 IGontschar@mednet.ucla.edu

Locations
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United States, California
Afshar Lab, Department of Obstetrics & Gynecology, UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Yalda Afshar, MD, PhD    310-794-7274    YAfshar@mednet.ucla.edu   
Contact: Irina Gontschar, MD, PhD    (747) 254-2558    IGontschar@mednet.ucla.edu   
Sponsors and Collaborators
Yalda Afshar, MD, PhD
University of California, Los Angeles
Investigators
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Principal Investigator: Yalda Afshar, MD, PhD University of California, Los Angeles
  Study Documents (Full-Text)

Documents provided by Yalda Afshar, MD, PhD, University of California, Los Angeles:
Informed Consent Form  [PDF] July 30, 2021

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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
ClinicalTrials.gov Identifier: NCT05035160    
Other Study ID Numbers: IRB#21-001018
First Posted: September 5, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
  1. Study Organization:

    The Perinatal Repository will be created and maintained by the investigator, initiated this project - Dr. Yalda Afshar, and designee - the Afshar's Lab. personnel.

  2. Request of the Repository Biospecimens and/ or Data by the Investigators or other Entities:

    The original task of the Perinatal Repository creation is to provide Afshar's Lab resources for ongoing and future clinical and non-clinical research.

  3. Access to the Repository Material may be granted to:

    • the PIs from the UCLA;
    • the PIs from other universities;
    • the institutions/ entities engaged in research in the field of health science and biotechnology.
  4. The PI, external to the Afshar's Lab, may contact the chief of the Repository for preliminary information. The adequacy of requests to obtain data and/or biospecimens is reviewed by the Committee on the terms and conditions established by the UCLA Perinatal Biospecimen Repository Advisory Committee Policy.
Supporting Materials: Study Protocol
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".

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yalda Afshar, MD, PhD, University of California, Los Angeles:
Fetus
Obstetrics
Perinatal Care
Pregnancy
Specimen Collection