SyncytiotrophoblastNCT02368821
From Cytotrophoblast to Syncytiotrophoblast
An observational study of Syncytiotrophoblast, run by Meir Medical Center.
Trial summary
A deeper understanding of the syncytiotrophoblast development processes and its properties may allow a better understanding of the placenta pathological process for the development of treatment models for the relevant pregnancy complications.The aim of this study is to compare telomere length, aggregate formation, and… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Syncytiotrophoblast
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: placentas from normal and complicated pregnancy
Who may be able to join
- placentas from normal and complicated pregnancy
Who cannot join
- women consent
About this study
Official title: From Cytotrophoblast to Syncytiotrophoblast - Telomere Length, Aggregate Formation and Senescence in Placenta From Complicated Pregnancies Compare to Placenta From Normal Pregnancies.
A deeper understanding of the syncytiotrophoblast development processes and its properties may allow a better understanding of the placenta pathological process for the development of treatment models for the relevant pregnancy complications.The aim of this study is to compare telomere length, aggregate formation, and senescence markers in placentas from complicated pregnancy with placentas from normal pregnancy.
Read the detailed description
Protocol summary No. 2 for research 0202-14 of date: 22/11/2014. Rationale for the research A deeper understanding of the syncytiotrophoblast development processes and its properties may allow a better understanding of the placenta pathological process for the development of treatment models for the relevant pregnancy complications.
The aim of this study is to compare telomere length, aggregate formation, and senescence markers in the syncytiotrophoblast of placentas from complicated pregnancy with placentas from normal pregnancy.
Telomere lenght and aggregate formation will be assessed by the fluorescent intensity of telomere FISH.
Senescence will be assessed by immunohistochemistry for the markers - SAHF, cyclin dependent kinase inhibitors p16/p21, HLAX, ERVWE1, SA-B-gal.
The study groups
- A retrospective arm - paraffin blocks which were collected over the years from placentas from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete) will be compared to blocks of placentas from normal pregnancies.
- The prospective arm - placental from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete) . Will be compared to placentas of normal pregnancies.
- A laboratory model based on human placenta cell cultures
- Conditions
- Syncytiotrophoblast
- Keywords
- cytotrophoblast, syncytiotrophoblast, placentas, intrauterine growth restriction, preeclampsia, placenta accrete
- Medical subject headings
- Fetal Growth Retardation, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| normal pregnancy | placental from normal pregnancy | |
| complacted pregnancy | placental from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of telomere and senescence markers amount in the placentas.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncytiotrophoblastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368821
- Sponsor's protocol ID
- 0202-14-MMC
- Status last verified
- Jan 2015
- First submitted
- 15 Jan 2015
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Cytotrophoblast to Syncytiotrophoblast - Telomere Length, Aggregate Formation and Senescence in Placenta From Complicated Pregnancies Compare to Placenta From Normal Pregnancies.
- ClinicalTrials.gov ID
- NCT02368821
- Acronym / sponsor ID
- 0202-14-MMC
- Conditions
- Syncytiotrophoblast
- Keywords
- cytotrophoblast, syncytiotrophoblast, placentas, intrauterine growth restriction, preeclampsia, placenta accrete
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2017 (estimated)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A deeper understanding of the syncytiotrophoblast development processes and its properties may allow a better understanding of the placenta pathological process for the development of treatment models for the relevant pregnancy complications.The aim of this study is to compare telomere length, aggregate formation, and senescence markers in placentas from complicated pregnancy with placentas from normal pregnancy.
Detailed description
Protocol summary No. 2 for research 0202-14 of date: 22/11/2014. Rationale for the research A deeper understanding of the syncytiotrophoblast development processes and its properties may allow a better understanding of the placenta pathological process for the development of treatment models for the relevant pregnancy complications.
The aim of this study is to compare telomere length, aggregate formation, and senescence markers in the syncytiotrophoblast of placentas from complicated pregnancy with placentas from normal pregnancy.
Telomere lenght and aggregate formation will be assessed by the fluorescent intensity of telomere FISH.
Senescence will be assessed by immunohistochemistry for the markers - SAHF, cyclin dependent kinase inhibitors p16/p21, HLAX, ERVWE1, SA-B-gal.
The study groups
- A retrospective arm - paraffin blocks which were collected over the years from placentas from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete) will be compared to blocks of placentas from normal pregnancies.
- The prospective arm - placental from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete) . Will be compared to placentas of normal pregnancies.
- A laboratory model based on human placenta cell cultures
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal pregnancy | – | –placental from normal pregnancy |
| complacted pregnancy | – | –placental from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- placentas from normal and complicated pregnancy
Key inclusion criteria (1 listed)
- placentas from normal and complicated pregnancy
Key exclusion criteria (1 listed)
- women consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of telomere and senescence markers amount in the placentas.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncytiotrophoblast, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of telomere and senescence markers amount in the placentas. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2015.