ADN Fœtal Circulant, Grossesse et Pathologies Malignes
Enrolling by invitation
Conditions studied: Femmes Enceintes, Cancer
In brief
In France in 2021, 90% of pregnant women chose to undergo screening for Trisomy 21, and 128,958 women benefited from a fetal aneuploidy screening test based on the analysis of cell-free DNA (cfDNA) in maternal blood. At the beginning of its use, this analysis was limited to screening for Trisomy 21, but it now allows the study of all chromosomes (expanded screening). More than half of fetal chromosomal abnormality screenings are expanded tests, and this practice continues to grow. In oncology, circulating tumor DNA (ctDNA) is studied for the detection, prognostic evaluation, and monitoring of the effectiveness of certain treatments. The high-throughput sequencing tools used for aneuploidy screening during pregnancy are likely to detect malignant diseases. Cancer is associated with pregnancy in 1 in 1,000 to 1 in 1,500 pregnant women, and the spread of expanded aneuploidy screening during pregnancy makes it possible to detect maternal cancers, including at infraclinical stages. This study will therefore help manage situations involving difficult-to-interpret results, such as suspected maternal cancer. It will make it possible to identify specific chromosomal abnormalities to be tested, which could potentially be included in future recommendations. In a second stage, it could contribute to harmonizing the practices of laboratory specialists performing fetal chromosomal abnormality screening using cfDNA.
Key facts
- Study ID
- NCT07448025
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 300
- Starts
- 2026-04-15
- Expected to finish
- 2028-11-15
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Inclusion Criteria (Cases):
- Adult patient (≥18 years old);
- Pregnant patient with a cancer known prior to pregnancy or diagnosed during pregnancy;
- Pregnancy at a gestational age > 10 weeks of amenorrhea at the time of inclusion;
- Patient informed and having signed the informed consent form to participate in the study.
You may not qualify if…
- Multiple pregnancy;
- Patient with a history of organ transplantation; Patient having received an allogeneic stem cell transplant;
- Known maternal mosaic chromosomal abnormality and copy number variation (CNV);
- Patient presenting with one or more known uterine fibroids at the time of inclusion;
- Technical inability to conduct a teleconsultation via a secure video connection and to complete an electronic signature.
Where it is running
- APHP - Antoine Béclère hospital — Clamart, France
Full record on ClinicalTrials.gov
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