Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05035160 |
| Other study ID # |
IRB#21-001018 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 30, 2021 |
| Est. completion date |
July 30, 2026 |
Study information
| Verified date |
September 2023 |
| Source |
University of California, Los Angeles |
| Contact |
Yalda Afshar, MD. PhD |
| Phone |
(805) 338-5593 |
| Email |
yafshar[@]mednet.ucla.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
Duration of the project - 5 years. The approximate number of participants - 500. The number
of visits - from one to 6. Duration of the subject's participation in the study - from 1 day
to 12 months. Follow-up period: from enrollment to postpartum visit. Core variables of
interest comprise the birthing person's/ fetus'/ neonate's clinical characteristics and
relevant biological samples: maternal blood, cord blood, plasma, serum, urine, breastmilk,
placenta, umbilical cord, amniotic fluid, the product of conception (POC), and cell lines.
Collection and retaining of the biospecimens will be performed by the study team across
perinatal pathology cases at the UCLA Health Medical Centers for up to 15 years.
Biospecimens will be collected prospectively to the Perinatal Repository. Clinical data will
be linked to the biospecimens.
Participation in the Repository Protocol can be offered by the PI/ designee for the
outpatients and inpatients. Eligibility criteria will be checked during the baseline visit.
The informed consent form should be signed at enrolment, following which baseline medical
history will be collected. Procedures and assessments will be performed according to the
routine standard at UCLA Health, and are documented as available (with the exception of
Informed Consent).
Enrolment/ Baseline Visit: After consenting, the birthing person will be asked to donate
blood (maternal blood) or/ and urine specimen to the Repository. Trained research team
personnel will collect the biospecimens per standard operating procedures. The study protocol
provides for the collection of blood samples as a procedure combined with routine blood
sampling for clinical laboratory testing.
For research purposes, it is intended to collect a small additional amount of the venous
maternal blood - less than 10 mL per procedure. The blood will not be drawn for research more
often than twice in a single week. Blood draws will be performed as follow: Red Top Tube
(Serology tube) - at least 4 mL and Lavender Top Tube (EDTA tube) - at least 4 mL. Blood
samples will be collected for whole blood, plasma, and serum banking.
Collection of the cord blood after delivery will be performed once in the same order. The
research Protocol does not involve collecting any specimens of the vital neonates, such as
venous blood or urine.
Follow-up Visits: For pregnant birthing persons, biospecimens donation during follow-up
visits is optional, based on the PI decision. Repository Material will be collected by the
research team during follow-up research visits (each once per pregnancy trimester):
1. st Trimester Visit (from conception to 12 weeks): medical history, pregnancy and fetus
status, AE, biobank specimens: blood and urine.
2. nd Trimester Visit (from week 13 to week 27): medical history, pregnancy and fetus
status, AE, biobank specimens: blood and urine.
3. rd Trimester Visit: (from week 28 until birth): medical history, pregnancy and fetus
status, biobank specimens: blood and urine.
Delivery/ End of Pregnancy Visit: Medical history, pregnancy status, pregnancy outcome,
neonatal/ fetus status, neonatal/ fetus outcome, AE, biobank specimens: maternal blood, cord
blood (UC blood), maternal urine, placenta, umbilical cord, amniotic fluid.
The umbilical cord and placenta are temporary fetus organs. For the Repository collection,
placenta, umbilical cord, and therefore, cord blood, will be obtained for the Repository
purposes after childbirth.
In case of a miscarriage, abortion, or stillbirth, the participant will be asked to donate
POC tissue to the Repository.
Postpartum Visit: Medical history, pregnancy outcome, neonatal status, neonatal outcome, AE,
biobank specimens: maternal blood, maternal urine, breastmilk.
For non-pregnant healthy volunteers, participation in the project is limited to the one-time
biospecimens donation and granting access to their medical records.
After collecting the necessary clinical information, all personal identifiable information of
the participant will be encoded. The PI will retain access to the codes.
In case of an MTA arrangement and providing access to the Repository to the third party, only
de-identified participants' information and de-identified biospecimens can be shared.
