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Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.
During pregnancy, biological screening for genetic diseases of the fetus cannot be implemented before the 11th week of amenorrhea whatever the technique used. This delay is long and distressing, particularly for people at high risk of transmission of genetic diseases. The presence of extravillous trophoblast cells to the cervix of the pregnant woman from the 7th week, accessible by a cervicovaginal smear non-invasive, represents new biological material representative of the fetal genome. This project aimed at evaluating the performance of a method for analyzing these trophoblast cells extra-villous at the start of pregnancy. The investigators want to evaluate performance analytical aspects of this method, that is to say, verifying that the genetic information resulting from these cells correspond to those of the fetus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women | Women who are pregnant between 7 and 16 weeks of amenorrhea (WA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inclusion (Visit 1 - Week 7-16) | Procedure | Extraction of cervico-vaginal sampling |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Establish an ultra-early detection method | Collect fetal phenotypic data obtained during the second or the 3rd trimester via ultrasound echography | Visit 2 (Week 20-24) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the ability of the method to provide a result in the context of a progressive pregnancy |
| Visit 2 (Week 20-24) |
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Inclusion Criteria:
Exclusions Criteria:
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Pregnant women with a priori genetic risk
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent GATINOIS, MD | Contact | 0 67 33 68 66 | v-gatinois@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Vincent GATINOIS, MD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier | Recruiting | Montpellier | France | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31431640 | Background | Bailey-Hytholt CM, Sayeed S, Kraus M, Joseph R, Shukla A, Tripathi A. A Rapid Method for Label-Free Enrichment of Rare Trophoblast Cells from Cervical Samples. Sci Rep. 2019 Aug 20;9(1):12115. doi: 10.1038/s41598-019-48346-3. | |
| 24825422 | Background | Bolnick JM, Kilburn BA, Bajpayee S, Reddy N, Jeelani R, Crone B, Simmerman N, Singh M, Diamond MP, Armant DR. Trophoblast retrieval and isolation from the cervix (TRIC) for noninvasive prenatal screening at 5 to 20 weeks of gestation. Fertil Steril. 2014 Jul;102(1):135-142.e6. doi: 10.1016/j.fertnstert.2014.04.008. Epub 2014 May 10. |
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| Second semester of pregnancy (Visit 2 - Week 20-24) |
| Diagnostic Test |
Ultrasound examination (determination of chromosomal sex) |
|
| Third semester of pregnancy (Visit 3- Week 34) | Diagnostic Test | Ultrasound examination (determination of chromosomal sex) if this has not be done during the Visit 2 or if a new determination correcting the previous one is provided. |
|
| Expected benefit of ultra-early cytogenetic information | Evaluate the ability of the method to provide a rapid result and evaluate the impact of information about pregnant women | Visit 2 (Week 20-24) |
| 28483162 | Background | Drewlo S, Armant DR. Quo vadis, trophoblast? Exploring the new ways of an old cell lineage. Placenta. 2017 Dec;60 Suppl 1(Suppl 1):S27-S31. doi: 10.1016/j.placenta.2017.04.021. Epub 2017 Apr 26. |
| 26051097 | Background | Fritz R, Kohan-Ghadr HR, Bolnick JM, Bolnick AD, Kilburn BA, Diamond MP, Drewlo S, Armant DR. Noninvasive detection of trophoblast protein signatures linked to early pregnancy loss using trophoblast retrieval and isolation from the cervix (TRIC). Fertil Steril. 2015 Aug;104(2):339-46.e4. doi: 10.1016/j.fertnstert.2015.05.010. Epub 2015 Jun 11. |
| 31226440 | Background | Kadam L, Jain C, Kohan-Ghadr HR, Krawetz SA, Drewlo S, Armant DR. Endocervical trophoblast for interrogating the fetal genome and assessing pregnancy health at five weeks. Eur J Med Genet. 2019 Aug;62(8):103690. doi: 10.1016/j.ejmg.2019.103690. Epub 2019 Jun 18. |
| 25218787 | Background | Mantzaris D, Cram DS. Potential of syncytiotrophoblasts isolated from the cervical mucus for early non-invasive prenatal diagnosis: evidence of a vanishing twin. Clin Chim Acta. 2015 Jan 1;438:309-15. doi: 10.1016/j.cca.2014.09.002. Epub 2014 Sep 8. |
| 29608700 | Background | Moser G, Drewlo S, Huppertz B, Armant DR. Trophoblast retrieval and isolation from the cervix: origins of cervical trophoblasts and their potential value for risk assessment of ongoing pregnancies. Hum Reprod Update. 2018 Jul 1;24(4):484-496. doi: 10.1093/humupd/dmy008. |
| 26680636 | Background | Pfeifer I, Benachi A, Saker A, Bonnefont JP, Mouawia H, Broncy L, Frydman R, Brival ML, Lacour B, Dachez R, Paterlini-Brechot P. Cervical trophoblasts for non-invasive single-cell genotyping and prenatal diagnosis. Placenta. 2016 Jan;37:56-60. doi: 10.1016/j.placenta.2015.11.002. Epub 2015 Nov 11. |
| 4102825 | Background | Shettles LB. Use of the Y chromosome in prenatal sex determination. Nature. 1971 Mar 5;230(5288):52-3. doi: 10.1038/230052b0. No abstract available. |