Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06339606 |
| Other study ID # |
4316 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2024 |
| Est. completion date |
April 30, 2031 |
Study information
| Verified date |
March 2024 |
| Source |
Sunnybrook Health Sciences Centre |
| Contact |
Sascha Drewlo, PhD |
| Phone |
1-416-480-6100 |
| Email |
sascha.drewlo[@]sri.utoronto.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
An essential part of clinical research is the availability and accessibility of human
biospecimens for the identification of biomarkers, new treatments and measurement of response
to therapy. Proteins, RNA and DNA can be extracted and studied as well. This is a critical
first step in performing many fundamental molecular biology experiments. A variety of
biospecimens are utilized for research including but not limited to normal and malignant
tissues, blood, and other body fluids.
In order to obtain high-quality biospecimens, they must be acquired serially, stored
according to current standards, and matched with clinical information for maximum value. As
such, the investigators would like to create a repository of biospecimens collected from
pregnant patients who are seen at Mount Sinai Hospital and other research hospitals in
Toronto. Mount Sinai provides personnel and infrastructure to serve the largest (7500
births/year) and highest complex Maternity program in Ontario. Of the 7500 patients a year,
at least 2500 are considered high risk pregnancies, where there's a possibility of
preeclampsia, placenta accreta and a host of other complications. For this study, biological
specimens - blood, cervical and placental samples - will be collected from these high-risk
groups in order to better understand the causes of the underlying conditions.
Description:
The study will be non-interventional and designed for prospective sample collection and
concurrent analysis.
Primary Objective #1: The primary objective is to provide a mechanism for system-wide patient
engagement for banking and sourcing high-quality biologic specimens including tissues and
bodily fluids. The study will be initiated at 3 sites - Sunnybrook Health Sciences Centre,
North York General Hospital and Mt.Sinai Hospital - in the hopes of creating a translational
research environment where patient data and biospecimens can inform future clinical practice.
The aim is to do this by:
1. Establishing a comprehensive, secure and de-identified registry/database that includes
current and future cases at high risk for abnormal placentation and healthy controls for
comparison with patient consent.
2. Comparing cases of suspected abnormal placentation with a control group of women with no
evidence of abnormal placentation.
Primary Objective #2: Feasibility study that aims to provide preliminary insights into the
biological markers and processes associated with abnormal placentation. By comparing a larger
control group to those experiencing abnormal placentation, the investigators seek to
understand potential biomarker differences. This phase is explorative in nature and is
designed to determine the viability of our research approach and generate preliminary data.
Secondary Objective: The secondary objective is to facilitate research studies with
utilization of these biologic specimens, including full-scale trials, should our initial
findings warrant them.
The blood samples will be useful in identifying the molecular biomarkers that are indicative
of disease, while the placental and cervical samples are important to better understand the
underlying physiology of perinatal disease. The aim is therefore to establish both a clinical
database and a blood/tissue bio-bank. By more comprehensively understanding the
pathophysiology of invasive placentation, the goal is to develop high specificity testing
modalities, perhaps through novel maternal serum biomarkers, to aid in diagnosis, management
and improved outcomes for both mothers and their babies.
Patients will be consented during their visit to the hospital, and blood/cervical samples
will be collected serially at each visit. Patient data will be collected from the Electronic
Medical Record systems and paper charts, and this will be entered into REDCap. The biological
samples will be sent to Sunnybrook Research Institute for storage.
Both blood and tissue specimens will be collected during regular patient visits. Biospecimens
will be labeled with an anonymous study identifier that will be linked to corresponding
clinical data and specimen annotation. Specimens will be stored in appropriate temperature
and storage conditions before they are transported to Sunnybrook - where the specimens will
be stored long-term. Specimens that are inadequate for study because of poor cell viability
or insufficient tissue will be destroyed.
Cervical and blood samples will be taken serially from patients during their regular clinic
visits. Up to 20 mL of blood and plasma may be collected for research use via venipuncture.
Efforts will be made to only collect the minimum volume necessary for research use. At the
patient's request, the research blood volume may be further reduced. Secondly, 10 mL of cord
blood will be collected after the delivery of the baby from the umbilical vein attached to
the placenta. Lastly, 1-5g samples of placental villous tissue will be collected after
delivery from all subjects who have consented to this. Removal of these very small amounts of
tissue will not interfere with routine histopathological examination conducted in the usual
clinical care of subjects. All these samples will be labelled with the appropriate study
number and kept at Sunnybrook for storage. Consent for biospecimen collection will also
include permission for future use of their de-identified samples in collaborative projects
with other institutions. All such collaborative projects would be subject to Ethics Board
consent and relevant material transfer agreements.
