Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Inclusion (Visit 1 - Week 7-16), Second semester of pregnancy (Visit 2 - Week 20-24), Third semester of pregnancy (Visit 3- Week 34).
- Кому может быть актуально
- Состояния в реестре: Pregnant Women. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.
Подробное описание
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.
Вмешательства
- Процедура Inclusion (Visit 1 - Week 7-16)
Extraction of cervico-vaginal sampling - Диагностический тест Second semester of pregnancy (Visit 2 - Week 20-24)
Ultrasound examination (determination of chromosomal sex) - Диагностический тест Third semester of pregnancy (Visit 3- Week 34)
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.
Первичные конечные точки
- Establish an ultra-early detection method [Срок оценки: Visit 2 (Week 20-24)]
Вторичные конечные точки (2)
- Evaluate the ability of the method to provide a result in the context of a progressive pregnancy [Срок оценки: Visit 2 (Week 20-24)]
- Expected benefit of ultra-early cytogenetic information [Срок оценки: Visit 2 (Week 20-24)]
Критерии участия
Критерии включения
- Pregnant woman
- Singleton pregnancy
- Pregnancy between 7 and 16 weeks of amenorrhea (WA)
- Woman ≥ 18 years
- Woman who has signed an informed consent
- Woman affiliated to social security or equivalent scheme
Exclusions Criteria:
- Person under guardianship or curatorship
- Person placed under legal protection
- Person unable to provide the participant with informed consent.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- CHU de Montpellier — Montpellier
Публикации
- 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. PMID 31431640
- 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. PMID 24825422
- 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. PMID 28483162
- 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. PMID 26051097
- 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. PMID 31226440
- 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. PMID 25218787
- 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. PMID 29608700
- 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. PMID 26680636
Идентификаторы
NCT: NCT06523543 · RECHMPL23_0417