{ "release_id": "c7fb95f1d15a7d13", "id": "maternal:next-study", "owner": "maternal", "kind": "study", "slug": "next-study", "name": "NEXT study (cell-free DNA for trisomy screening)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "A large study at 35 centres in which pregnant women had both standard first-trimester screening and a cell-free DNA blood test, with the DNA result kept hidden. The DNA test found trisomy 21 more reliably and gave far fewer false alarms. The test maker paid for the study.", "summary_technical": "Prospective, multicentre, blinded comparison (NEJM 2015; ClinicalTrials.gov NCT01511458, observational, completed). 18,955 women were enrolled and 15,841 analysed. Primary outcome: area under the ROC curve for trisomy 21, 0.999 for cfDNA testing against 0.958 for standard screening. Funded by Ariosa Diagnostics and the Perinatal Quality Foundation; the registry lists Roche Sequencing Solutions (industry) as lead sponsor. Primary comparator and test: the Ariosa Harmony Prenatal Test and combined first-trimester screening, per the registry.", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [ { "scheme": "nct", "value": "NCT01511458", "normalized_value": "NCT01511458", "match": "exact", "version": null, "label": null, "from_source": false } ], "navigation": { "maternal": { "life-stage": [ "pregnancy" ], "care-area": [ "fetal-development" ] } }, "payload": { "design": "Prospective, multicentre, blinded study at 35 international centres. Pregnant women presenting for aneuploidy screening at 10 to 14 weeks of gestation had both standard screening (nuchal translucency and biochemical analytes) and cfDNA testing; participants received only the standard results. Birth outcome was determined by diagnostic genetic testing or newborn examination.", "drug_phase": null, "registry_statuses": [ { "status": "COMPLETED", "snapshot": "maternal:ctgov-nct01511458-2026-10-14" } ], "start_date": { "date": "2012-03", "type": null, "snapshot": "maternal:ctgov-nct01511458-2026-10-14" }, "primary_completion_date": { "date": "2013-11", "type": "actual", "snapshot": "maternal:ctgov-nct01511458-2026-10-14" }, "completion_date": { "date": "2014-05", "type": "actual", "snapshot": "maternal:ctgov-nct01511458-2026-10-14" }, "results_first_posted": null, "countries": [ { "code": "US", "snapshot": "maternal:ctgov-nct01511458-2026-10-14" }, { "code": "BE", "snapshot": "maternal:ctgov-nct01511458-2026-10-14" }, { "code": "CA", "snapshot": "maternal:ctgov-nct01511458-2026-10-14" }, { "code": "IT", "snapshot": "maternal:ctgov-nct01511458-2026-10-14" }, { "code": "NL", "snapshot": "maternal:ctgov-nct01511458-2026-10-14" }, { "code": "SE", "snapshot": "maternal:ctgov-nct01511458-2026-10-14" } ], "care_setting": null, "stopped_early": null, "enrollment": [ { "count": 18955, "basis": "enrolled", "unit": "women (registry enrollment, type ACTUAL)", "snapshot": "maternal:ctgov-nct01511458-2026-10-14" }, { "count": 18955, "basis": "enrolled", "unit": "women", "snapshot": "maternal:pubmed-25830321-2026-10-14" }, { "count": 15841, "basis": "analyzed", "unit": "women (results available for analysis)", "snapshot": "maternal:pubmed-25830321-2026-10-14" } ], "arms": [], "findings": [] }, "content_digest": "6f2a1bb5140422fd26f7aae6fa0721f2632dd524f1206f9c6ebce66250bd4560", "review": { "content_digest": "6f2a1bb5140422fd26f7aae6fa0721f2632dd524f1206f9c6ebce66250bd4560", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-next-trisomy-21", "owner": "maternal", "subject_entity_id": "maternal:next-study", "category": "descriptive", "statement": "NEXT was a prospective, multicentre, blinded study at 35 international centres in which pregnant women presenting for aneuploidy screening at 10 to 14 weeks had both standard first-trimester screening (nuchal translucency and biochemical analytes) and cell-free DNA testing. Women received only the standard screening results; the cfDNA results were blinded. Of 18,955 women enrolled, results from 15,841 were analysed. For trisomy 21 the area under the ROC curve was 0.999 for cfDNA testing and 0.958 for standard screening (P=0.001). Trisomy 21 was detected in 38 of 38 women (100%; 95% CI 90.7 to 100) with cfDNA testing and 30 of 38 (78.9%; 95% CI 62.7 to 90.4) with standard screening. False positive rates were 0.06% (95% CI 0.03 to 0.11) with cfDNA and 5.4% (95% CI 5.1 to 5.8) with standard screening. The positive predictive value was 80.9% (95% CI 66.7 to 90.9) for cfDNA testing and 3.4% (95% CI 2.3 to 4.8) for standard screening.", "context": { "id": "maternal:ctx-next-fetuses", "label": "Fetuses of pregnant women having first-trimester aneuploidy screening at 35 centres (NEXT)", "recipient": "fetal", "population": "Fetuses of 15,841 pregnant women (of 18,955 enrolled) presenting for aneuploidy screening at 10 to 14 weeks of gestation, whose results were available for analysis. Mean maternal age was 30.7 years and the mean gestational age at testing was 12.5 weeks. The women gave the blood sample; the chromosome status of the fetus is what was tested.", "care_setting": "35 international centres", "geography": "Six countries in the registry record: United States, Belgium, Canada, Italy, the Netherlands and Sweden", "life_stage_note": "Pregnancy, 10 to 14 weeks of gestation at testing", "life_stage_terms": { "maternal": [ "pregnancy" ] }, "gestational_age_min_days": 70, "gestational_age_max_days": 100, "gestational_age_basis": "at_measurement", "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Birth outcome by diagnostic genetic testing or newborn examination", "eligibility": { "inclusion": [ "Pregnant women presenting for aneuploidy screening at 10 to 14 weeks of gestation" ], "exclusion": [ "Not stated in the parts of the source that were read." ] } }, "evidence_stage": "observational", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is a screening comparison, not a diagnosis: a cfDNA result needs confirmation by other tests, and a positive predictive value of 80.9% means a positive cfDNA result was not always correct. Only 38 pregnancies had trisomy 21, so the intervals are wide. The registry names one test, the Ariosa Harmony Prenatal Test, so the results do not describe every cfDNA test. The study was funded by Ariosa Diagnostics, which made the test studied, and by the Perinatal Quality Foundation; the registry lists Roche Sequencing Solutions, an industry sponsor. The abstract also evaluates trisomies 18 and 13 but the parts read give no numbers for them. The registry's eligibility text gives a gestational age of 10 weeks 0 days to 14 weeks 2 days at blood collection, slightly wider than the abstract's 10 to 14 weeks. Only the abstract and the registry record were read.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, METHODS, sentence 1, fragment 1 of 2", "applicability_note": "PubMed abstract.", "snapshot": { "id": "maternal:pubmed-25830321-2026-10-14", "retrieved_at": "2026-10-14T18:18:28Z", "content_hash": "0044c214d8a4eb6ef93b5aead13513e02785b1baf07c54a0c9ef844bb1ff0e0d", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:pubmed-10-1056-nejmoa1407349", "source_type": "publication", "title": "Cell-free DNA analysis for noninvasive examination of trisomy", "canonical_url": "https://doi.org/10.1056/NEJMoa1407349", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1407349", "normalized_value": "10.1056/nejmoa1407349", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "25830321", "normalized_value": "25830321", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2015-04-23", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. 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