Fetal AnomalyNCT02965287
Validation of a Test for Fetal Malformations
An observational study of Fetal Anomaly, run by Theoreo Srl at 1 site in Italy.
Trial summary
The investigators have developed a diagnostic test for the evaluation of the presence of fetal malformations through metabolomic analysis of maternal peripheral blood serum by chromatographic techniques and mass spectrometry, and subsequent mathematical modeling analysis of the data by means of multivariate… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Anomaly
- What is being tested?
- Serum metabolomics profiling
- How many people
- 1,943 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2016to Dec 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population is the ones selected by the SCOPE Study in New Zealand
Who may be able to join
- Nulliparous women, with a singleton pregnancy, between 14wks, 0 days and 16wks, 6 days gestation who give informed consent to participate in SCOPE.
Who cannot join
- Unsure of last menstrual period (LMP)
- Unwilling to have ultrasound scan at ≤20 weeks
- ≥3 miscarriages
- ≥3 terminations
- Essential hypertension treated pre-pregnancy
- Moderate-severe hypertension at booking ≥160/100 mmHg
Show all 22Show fewer
- Diabetes
- Renal disease
- Systemic lupus erythematosus
- Anti-phospholipid syndrome
- Sickle cell disease
- HIV positive
- Major uterine anomaly
- Cervical suture
- Knife cone biopsy
- Ruptured membranes now
- Long term steroids
- Treatment low-dose aspirin
- Treatment calcium (>1g/24h)
- Treatment eicosapentanoic acid (fish oil)
- Treatment vitamin C ≥1000 mg \& Vit E ≥400 iu
- Treatment heparin/low molecular weight heparin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blind Validation of a Metabolomics Based Test for the Non-invasive Screening of Fetal Malformations
The investigators have developed a diagnostic test for the evaluation of the presence of fetal malformations through metabolomic analysis of maternal peripheral blood serum by chromatographic techniques and mass spectrometry, and subsequent mathematical modeling analysis of the data by means of multivariate mathematical models specifically developed for this purpose. The study aims at determining the performance parameters (specificity, sensibility, positive predictive value (PPN), negative predictive value (NPV), etc.) of the test and its applicability. To do this, the investigators will use the serum samples of the patients enrolled in New Zealand in the SCOPE Study (www.scopestudy.net), an international study conducted between years 2004-2008.
Read the detailed description
The test has been developed in a case-control study. In this clinical trial the investigators will test it in a large cohort that is likely to resemble a real population. The purpose of validation is to see if the test is able to recognize the few malformed fetuses in the entire population and especially its specificity in real conditions. In addition, the investigators will check whether particular maternal conditions (such as preeclampsia, gestational diabetes, etc.) or fetal conditions (Small for gestational age, Large for gestational age, etc.) affect the test results.
- Conditions
- Fetal Anomaly
- Being tested
- Serum metabolomics profiling
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum metabolomics profilingOther
The serum samples will be used to get a metabolomic profile
| Study group | Role | What they receive |
|---|---|---|
| 19-21 weeks' gestation | The test validation will be performed on the 1943 serum samples of pregnant women at 19-21 weeks' gestation recruited in New Zealand for the SCOPE Study.
All the samples will be analyzed to extract and purify the whole metabolome. Metabolites will be characterized through mass spectrometric techniques. These data will be interpreted by means of a bioinformatic algorithm specifically designed for this purpose. Receives: Other: Serum metabolomics profiling | |
| 14-16 weeks' gestation | Five hundred subjects at 14-16 weeks gestation were randomly selected from the whole cohort of patients. The serum samples collected at 14-16 weeks gestation will be used to test the diagnostic performance at this earlier gestational phase. Receives: Other: Serum metabolomics profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic test performance evaluation in dichotomic classification at 19-21 weeks' gestation
Assessment of the sensitivity, likelihood ratios and performances (diagnostic accuracy) in the identification of a malformed fetus through the analysis of a serum sample from a mother at 19-21 weeks' gestation
Measured: 6 months
Diagnostic test performance evaluation in the individuation of the exact diagnosis of fetal malformation at 19-21 weeks' gestation
Assessment of the sensitivity, likelihood ratios and performances (diagnostic accuracy) in the identification of the type of malformation through the analysis of a serum sample from a mother at 19-21 weeks' gestation
Measured: 6 months
Secondary outcomes (2)
Diagnostic test performance evaluation in dichotomic classification at 14-16 weeks gestation
Assessment of the sensitivity, likelihood ratios and performances (diagnostic accuracy) in the identification of a malformed fetus through the analysis of a serum sample from a mother at 19-21 weeks' gestation
Measured: 6 months
Diagnostic test performance evaluation in the individuation of the exact diagnosis of fetal malformation at 14-16 weeks gestation
Assessment of the sensitivity, likelihood ratios and performances (diagnostic accuracy) in the identification of the type of malformation through the analysis of a serum sample from a mother at 14-16 weeks gestation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal AnomalyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,943 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theoreo Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Auckland UniServices Ltd., Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Jacopo Troisi, Dr., Principal investigator, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965287
- Sponsor's protocol ID
- MV-01
- Status last verified
- Oct 2017
- First submitted
- 14 Nov 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Test validation of the screening technique will be conducted blinded. The investigators will have access only to the serum samples identified by their unique ID. At the end of the analytical phase, the database containing results will be locked. The database will be transferred to an independent investigator (Prof. Alessio Fasano at Mass General Hospital for Children, Boston, USA) for data analysis. At the same time, information related to pregnancy outcomes (in terms of presence or absence of fetal anomaly) will be transferred from the University of Auckland to the Mass General Hospital for Children, which will provide the blind break and will procced to the estimation of the test performance.
Publications
McCowan LM, Thompson JM, Taylor RS, North RA, Poston L, Baker PN, Myers J, Roberts CT, Dekker GA, Simpson NA, Walker JJ, Kenny LC; SCOPE Consortium. Clinical prediction in early pregnancy of infants small for gestational age by customised birthweight centiles: findings from a healthy nulliparous cohort. PLoS One. 2013 Aug 5;8(8):e70917. doi: 10.1371/journal.pone.0070917. Print 2013.
PubMed 23940665
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blind Validation of a Metabolomics Based Test for the Non-invasive Screening of Fetal Malformations
- ClinicalTrials.gov ID
- NCT02965287
- Acronym / sponsor ID
- MV-01
- Conditions
- Fetal Anomaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,943 participants (estimated)
- Lead sponsor
- Theoreo SrlIndustry (pharma, biotech, devices)
- Collaborators
- Auckland UniServices Ltd., Massachusetts General Hospital
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Nov 2016 (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.
The investigators have developed a diagnostic test for the evaluation of the presence of fetal malformations through metabolomic analysis of maternal peripheral blood serum by chromatographic techniques and mass spectrometry, and subsequent mathematical modeling analysis of the data by means of multivariate mathematical models specifically developed for this purpose. The study aims at determining the performance parameters (specificity, sensibility, positive predictive value (PPN), negative predictive value (NPV), etc.) of the test and its applicability. To do this, the investigators will use the serum samples of the patients enrolled in New Zealand in the SCOPE Study (www.scopestudy.net), an international study conducted between years 2004-2008.
Detailed description
The test has been developed in a case-control study. In this clinical trial the investigators will test it in a large cohort that is likely to resemble a real population. The purpose of validation is to see if the test is able to recognize the few malformed fetuses in the entire population and especially its specificity in real conditions. In addition, the investigators will check whether particular maternal conditions (such as preeclampsia, gestational diabetes, etc.) or fetal conditions (Small for gestational age, Large for gestational age, etc.) affect the test results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 19-21 weeks' gestation | – | Other: Serum metabolomics profilingThe test validation will be performed on the 1943 serum samples of pregnant women at 19-21 weeks' gestation recruited in New Zealand for the SCOPE Study. All the samples will be analyzed to extract and purify the whole metabolome. Metabolites will be characterized through mass spectrometric techniques. These data will be interpreted by means of a bioinformatic algorithm specifically designed for this purpose. |
| 14-16 weeks' gestation | – | Other: Serum metabolomics profilingFive hundred subjects at 14-16 weeks gestation were randomly selected from the whole cohort of patients. The serum samples collected at 14-16 weeks gestation will be used to test the diagnostic performance at this earlier gestational phase. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is the ones selected by the SCOPE Study in New Zealand
Key inclusion criteria (1 listed)
- Nulliparous women, with a singleton pregnancy, between 14wks, 0 days and 16wks, 6 days gestation who give informed consent to participate in SCOPE.
Key exclusion criteria (22 listed)
- Unsure of last menstrual period (LMP)
- Unwilling to have ultrasound scan at ≤20 weeks
- ≥3 miscarriages
- ≥3 terminations
- Essential hypertension treated pre-pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum metabolomics profilingThe serum samples will be used to get a metabolomic profile | Other | 14-16 weeks' gestation, 19-21 weeks' gestation |
Primary outcome
Diagnostic test performance evaluation in dichotomic classification at 19-21 weeks' gestation
Time frame: 6 months
Assessment of the sensitivity, likelihood ratios and performances (diagnostic accuracy) in the identification of a malformed fetus through the analysis of a serum sample from a mother at 19-21 weeks' gestation
Diagnostic test performance evaluation in the individuation of the exact diagnosis of fetal malformation at 19-21 weeks' gestation
Time frame: 6 months
Assessment of the sensitivity, likelihood ratios and performances (diagnostic accuracy) in the identification of the type of malformation through the analysis of a serum sample from a mother at 19-21 weeks' gestation
2 secondary outcomes
Diagnostic test performance evaluation in dichotomic classification at 14-16 weeks gestation
Time frame: 6 months
Diagnostic test performance evaluation in the individuation of the exact diagnosis of fetal malformation at 14-16 weeks gestation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Background: PubMed 23940665McCowan LM, Thompson JM, Taylor RS, North RA, Poston L, Baker PN, Myers J, Roberts CT, Dekker GA, Simpson NA, Walker JJ, Kenny LC; SCOPE Consortium. Clinical prediction in early pregnancy of infants small for gestational age by customised birthweight centiles: findings from a healthy nulliparous cohort. PLoS One. 2013 Aug 5;8(8):e70917. doi: 10.1371/journal.pone.0070917. Print 2013.
- Individual participant dataSharing planned: Yes. Test validation of the screening technique will be conducted blinded. The investigators will have access only to the serum samples identified by their unique ID. At the end of the analytical phase, the database containing results will be locked. The database will be transferred to an independent investigator (Prof. Alessio Fasano at Mass General Hospital for Children, Boston, USA) for data analysis. At the same time, information related to pregnancy outcomes (in terms of presence or absence of fetal anomaly) will be transferred from the University of Auckland to the Mass General Hospital for Children, which will provide the blind break and will procced to the estimation of the test performance.
Related trials for Fetal Anomaly
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Hydrops: Diagnosing & Redefining Outcomes With Precision Study
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Genomic Sequencing for Evaluation of Fetal Structural Anomalies
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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.
Jacopo Troisi, Dr. principal investigator
CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Anomaly, run by Theoreo Srl at 1 site in Italy.
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 22 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: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic test performance evaluation in dichotomic classification at 19-21 weeks' gestation (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02965287, which also lists 1 linked publication.
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 22 Mar 2018; AzTrials last refreshed its copy on 1 Nov 2026.