RECRUITING

UCLA Perinatal Biospecimen Repository

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

UCLA Perinatal Biospecimen Repository

Quick Facts

Study Start:2021-07-30
Study Completion:2026-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05035160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Minute
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant and postpartum birthing persons aged 18 and over with perinatal pathology;
  2. * Healthy pregnant and postpartum birthing persons;
  3. * Healthy non-pregnant birthing persons (healthy volunteers).
  1. * Pregnant and postpartum birthing person unwilling to give written informed consent to participate in the study.

Contacts and Locations

Study Contact

Yalda Afshar, MD. PhD
CONTACT
(805) 338-5593
yafshar@mednet.ucla.edu
Anhyo Jeong, BS
CONTACT
(805) 679-3915
AnhyoJeong@mednet.ucla.edu

Principal Investigator

Yalda Afshar, MD, PhD, MD. PHD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

Afshar Lab, Department of Obstetrics & Gynecology, UCLA
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: Yalda Afshar, MD, PhD

  • Yalda Afshar, MD, PhD, MD. PHD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-30
Study Completion Date2026-07-30

Study Record Updates

Study Start Date2021-07-30
Study Completion Date2026-07-30

Terms related to this study

Keywords Provided by Researchers

  • Fetus
  • Obstetrics
  • Perinatal Care
  • Pregnancy
  • Specimen Collection

Additional Relevant MeSH Terms

  • Pregnancy
  • High-Risk Pregnancy