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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06427408
Other study ID # APHP240045
Secondary ID 2022-A02452-41
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date May 2027

Study information

Verified date May 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Vassilis TSATSARIS, MD PHD
Phone 00331 58 41 38 71
Email vassilis.tsatsaris@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The single nucleus RNA-seq approach allows the placental transcriptome to be analyzed from nuclei, thus preserving the integrity of placental syncytium. This approach is feasible on small fragments of villi and offers for the first time the possibility to consider the characterization of gene expression within the structural unit of the human placenta during pregnancy (at the 1st trimester and childbirth)


Description:

Chorionic villus biopsies are routinely performed between 11SA and 15SA at the Fetal Medicine Unit́ of the Port-Royal Maternity Hospital (CPDPN Cochin) after the patient has signed an information and consent form for the genetic analysis. The patient will be asked to participate to the VilliRNAseq project and will sign the consent form of the study. After the cytogeneticist observation, a villi fragment will be snap-frozen in liquid nitrogen and stored at -80°C until use. Each patient sampled in the first trimester is followed until the end of the pregnancy. At delivery, cesarean section or vaginal delivery, a placental sample will be snap-frozen in liquid nitrogen and stored at -80°C until use. Isolation, sorting and encapsidation of nuclei, RNA libraries preparation and sequencing will be carried out using 10x Genomics technology. State-of-the-art computational analyses to decipher trajectories and cell-to-cell communications.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date May 2027
Est. primary completion date February 2027
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Age 18 to 50 - Progressive monofoetal pregnancy between 11 and 15 weeks of amenorrhea - Patient with prenatal medical indication and requesting chorionic villus biopsy with cytogenetic analysis or molecular genetics - Patient scheduled for delivery at Port-Royal Maternity Hospital Exclusion Criteria: - Minor patient - Multiple pregnancy - Patient's objection - Without health insurance - Patient under guardianship or curatorship

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non applicable
Placental transcriptomic analysis

Locations

Country Name City State
France Maternité Port-Royal, Cochin hospital Paris IDF

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Analysis of the cellular transcriptomic trajectory of the human placenta Sequencing data will be analysed at the Institut Cochin, cell trajectories will be modelled and intracellular communications will be inferred Day 0
Primary Analysis of the cellular transcriptomic trajectory of the human placenta Sequencing data will be analysed at the Institut Cochin, cell trajectories will be modelled and intracellular communications will be inferred At childbirth
Secondary Collection of placental samples Day 0
Secondary Collection of placental samples At childbirth
Secondary Identification of early markers of pregnancy complications Pre-eclampsia, growth retardation in utero, delivery before 37 SA Until at Childbirth
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