Validation of New Test NIPTNIPTNCT05618431
Validate Non-invasive Prenatal Tests for the Detection of Chromosomal Abnormalities
A study testing NIPT in people with Validation of New Test NIPT, run by CerbaXpert at 1 site in France.
Trial summary
This study will be conducted on pregnant patients for whom there is a suspicion of a chromosomal abnormality of the fetus. These are patients eligible for non-invasive prenatal screening as part of their usual pregnancy surveillance. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Validation of New Test NIPT
- What is being tested?
- NIPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,790 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to 1 Jun 2024
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Pregnant woman between 10 and 40 weeks of pregnancy 2. Gestational age at time of collection of the known sample 3. Maternal age 18-50 years 4. Sex of the fetus or newborn known (confirmed by doctor or karyotype) 5. Number of known fetuses 6.a) for affected samples: result of the karyotype available 6.b) for unaffected samples: preferably, result of the available karyotype; A secondarily negative NIPT result associated with a doctor's confirmation of the delivery of a healthy baby.
- 7. Have a diagnostic result (such as amniocentesis or CVS) available if NIPT is positive 8. Patients Affiliated to a social security scheme or entitled to.
- Non-inclusion criteria
- Confirmed mosaic sample
- Confirmed maternal mosaicism
- Recent maternal blood transfusion known
Show all 11Show fewer
- Patient who received an organ transplant
- Patient who underwent surgery
- Patient on immunotherapy or stem cell therapy and/or other maternal malignancy
- Patient already included in the study during pregnancy
- Patient under guardianship or curatorship or safeguard of justice
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
APHP
Paris
BENACCHI Alexandra, 0141657832, alexandra.benacchi@aphp.fr
About this study
Official title: Prospective Biological Sample Collection Aiming to Validate Non-invasive Prenatal Tests by Analyzing Fetal DNA Present in Maternal Blood Using a Next-generation Digital PCR Technique
This study will be conducted on pregnant patients for whom there is a suspicion of a chromosomal abnormality of the fetus. These are patients eligible for non-invasive prenatal screening as part of their usual pregnancy surveillance. This research aims to develop and validate a new method for non-invasive prenatal testing.
This prospective collection study will allow the collection of biological samples necessary for the development, testing and validation of these new tests
Read the detailed description
The main objective : of the study is the validation of non-invasive prenatal tests for the detection of chromosomal abnormalities by analyzing the fetal DNA present in maternal blood by a new generation digital PCR.
The secondary objective of this research: is to validate the reliability of the test on both populations (affected and unaffected) and its ability to detect the following anomalies: Triple X and 22q.11.2 Micro-deletion.
Type and methodology of research :
Although the only act of the research being the sampling of a maximum of 3 additional blood tubes for a maximum volume of 30 mL during a blood test as part of the care, this study is qualified as research involving the human person at risk and minimal constraints.
Provisional research calendar :
The inclusion period for subjects is 18 months, from the date of inclusion of the first patient.
The duration of the subjects' participation in this research protocol is related to the time of inclusion and the procedure of blood collection by venipuncture.
The end of participation of patients included in the study is effective as soon as the collection of the sample is completed.
Primary endpoint:
Evaluation of the non-inferiority of a new non-invasive test for the detection of chromosomal abnormalities and to determine the accuracy of fetal sex classification by the new NIPT method combined with next-generation digital PCR from acellular fetal DNA found in maternal plasma.
Secondary endpoint:
Evaluation of test performance in both populations (affected and unaffected) Evaluation of the performance of the test to detect the following anomalies: Triple X and 22q.11.2 Micro-deletion.
- Conditions
- Validation of New Test NIPT
- Being tested
- NIPT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPTOther
This research aims to develop and validate a new method for non-invasive prenatal testing
| Study group | Role | What they receive |
|---|---|---|
| pregnant women | Other | Pregnant woman 18 and 50 years oldbetween 10 and 40 weeks of pregnancy Receives: Other: NIPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the non-inferiority of a new non-invasive test for the detection of chromosomal abnormalities by analyzing the fetal DNA present in maternal blood by a new generation digital PCR
As part of this study, comparative analyses will be carried out:
For qualitative variables: Pearson's Chi ² test will be used unless the estimated theoretical number in a cell is less than five, in which case the Yates continuity correction or the exact Fisher test will be applied.
For quantitative variables: the t-test or an analysis of Student's variance will be performed. Otherwise, post-hoc analyses will be performed using the Student-Neuman-Keuls test. If the data is not distributed normally, nonparametric tests will be used.
Measured: 18 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 2022
- Study start1 Feb 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation of New Test NIPTStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Demonstrating non-inferiority means ensuring that the product tested does not have an efficacy that would be too inferior to the reference product.
- Masking
- None (open label)
- Enrolment
- 1,790 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CerbaXpert
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618431
- Sponsor's protocol ID
- 2022-A00290-43
- Acronym
- NIPT
- Status last verified
- Dec 2023
- First submitted
- 1 Nov 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Biological Sample Collection Aiming to Validate Non-invasive Prenatal Tests by Analyzing Fetal DNA Present in Maternal Blood Using a Next-generation Digital PCR Technique
- ClinicalTrials.gov ID
- NCT05618431
- Acronym / sponsor ID
- NIPT / 2022-A00290-43
- Conditions
- Validation of New Test NIPT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,790 participants (estimated)
- Lead sponsor
- CerbaXpertUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 16 Nov 2022 (actual)
- 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.
This study will be conducted on pregnant patients for whom there is a suspicion of a chromosomal abnormality of the fetus. These are patients eligible for non-invasive prenatal screening as part of their usual pregnancy surveillance. This research aims to develop and validate a new method for non-invasive prenatal testing.
This prospective collection study will allow the collection of biological samples necessary for the development, testing and validation of these new tests
Detailed description
The main objective : of the study is the validation of non-invasive prenatal tests for the detection of chromosomal abnormalities by analyzing the fetal DNA present in maternal blood by a new generation digital PCR.
The secondary objective of this research: is to validate the reliability of the test on both populations (affected and unaffected) and its ability to detect the following anomalies: Triple X and 22q.11.2 Micro-deletion.
Type and methodology of research :
Although the only act of the research being the sampling of a maximum of 3 additional blood tubes for a maximum volume of 30 mL during a blood test as part of the care, this study is qualified as research involving the human person at risk and minimal constraints.
Provisional research calendar :
The inclusion period for subjects is 18 months, from the date of inclusion of the first patient.
The duration of the subjects' participation in this research protocol is related to the time of inclusion and the procedure of blood collection by venipuncture.
The end of participation of patients included in the study is effective as soon as the collection of the sample is completed.
Primary endpoint:
Evaluation of the non-inferiority of a new non-invasive test for the detection of chromosomal abnormalities and to determine the accuracy of fetal sex classification by the new NIPT method combined with next-generation digital PCR from acellular fetal DNA found in maternal plasma.
Secondary endpoint:
Evaluation of test performance in both populations (affected and unaffected) Evaluation of the performance of the test to detect the following anomalies: Triple X and 22q.11.2 Micro-deletion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Demonstrating non-inferiority means ensuring that the product tested does not have an efficacy that would be too inferior to the reference product.
| Arm | Type | Receives |
|---|---|---|
| pregnant women | Other | Other: NIPTPregnant woman 18 and 50 years oldbetween 10 and 40 weeks of pregnancy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 1. Pregnant woman between 10 and 40 weeks of pregnancy 2. Gestational age at time of collection of the known sample 3. Maternal age 18-50 years 4. Sex of the fetus or newborn known (confirmed by doctor or karyotype) 5. Number of known fetuses 6.a) for affected samples: result of the karyotype available 6.b) for unaffected samples: preferably, result of the available karyotype; A secondarily negative NIPT result associated with a doctor's confirmation of the delivery of a healthy baby.
- 7. Have a diagnostic result (such as amniocentesis or CVS) available if NIPT is positive 8. Patients Affiliated to a social security scheme or entitled to.
- Non-inclusion criteria
- Confirmed mosaic sample
- Confirmed maternal mosaicism
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| NIPTThis research aims to develop and validate a new method for non-invasive prenatal testing | Other | pregnant women |
Primary outcome
Evaluation of the non-inferiority of a new non-invasive test for the detection of chromosomal abnormalities by analyzing the fetal DNA present in maternal blood by a new generation digital PCR
Time frame: 18 months
As part of this study, comparative analyses will be carried out: For qualitative variables: Pearson's Chi ² test will be used unless the estimated theoretical number in a cell is less than five, in which case the Yates continuity correction or the exact Fisher test will be applied. For quantitative variables: the t-test or an analysis of Student's variance will be performed. Otherwise, post-hoc analyses will be performed using the Student-Neuman-Keuls test. If the data is not distributed normally, nonparametric tests will be used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIPT in people with Validation of New Test NIPT, run by CerbaXpert at 1 site in France.
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 11 inclusion and 0 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 6 Dec 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the non-inferiority of a new non-invasive test for the detection of chromosomal abnormalities by analyzing the fetal DNA present in maternal blood by a new generation digital PCR (time frame: 18 months). 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 6 Dec 2023.