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NCT05035160 · ClinicalTrials.gov registry record
UCLA Perinatal Biospecimen Repository
A clinical trial of Pregnancy and High Risk Pregnancy, sponsored by Yalda Afshar, MD, PhD.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 1
- Study location
NCT05035160 is a study of Pregnancy and High Risk Pregnancy that is actively recruiting participants, run by Yalda Afshar, MD, PhD. The registered enrollment target is 1,000 participants, above the 867-participant average among 191 other Pregnancy trials with a reported enrollment target (15% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05035160, a study of Pregnancy and High Risk Pregnancy, is actively recruiting participants, sponsored by Yalda Afshar, MD, PhD.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Study Locations (1)
California
- Afshar Lab, Department of Obstetrics & Gynecology, UCLA - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2021-07-30 |
| Est. Completion | 2028-12-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05035160
The ClinicalTrials.gov registry entry for NCT05035160 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 867-participant average among 191 other Pregnancy trials with a reported enrollment target (15% higher). The listed sponsor is Yalda Afshar, MD, PhD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pregnancy appearing as the primary indexed condition, and to 0 interventions.
NCT05035160 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05035160 about?
NCT05035160 is a clinical study titled "UCLA Perinatal Biospecimen Repository". 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...
What is the current status of trial NCT05035160?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2021-07-30. Estimated completion is 2028-12-31.
What conditions does trial NCT05035160 study?
This clinical trial studies the following conditions: Pregnancy, High Risk Pregnancy.
Who is sponsoring clinical trial NCT05035160?
This trial is sponsored by Yalda Afshar, MD, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05035160 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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