Study to Compare Traditional and Emerging Methods for Structural Variant Analysis in Prenatal, Postnatal, and Hematologic Samples
NCT07930832, Recruiting, 4bases Italia Srl
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Study to Compare Traditional and Emerging Methods for Structural Variant Analysis in Prenatal, Postnatal, and Hematologic Samples | ClinicalTrials.gov |
| NCT number | NCT07930832 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | 4bases Italia Srl | ClinicalTrials.gov |
| Conditions | Chromosome Aberrations, Aneuploidy, Chromosome Deletion, Chromosome Duplication, Abnormal Karyotype, Copy Number Variation | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Overall diagnostic concordance between KaryoSolver and reference methods for the identification of clinically detectable structural variants. | through study completion, an average of 1 year | ClinicalTrials.gov | |
| Primary | Agreement on the presence/absence of clinically relevant chromosomal alterations between KaryoSolver and reference methods | through study completion, an average of 1 year | ClinicalTrials.gov | |
| Primary | Agreement by category of identified alteration (aneuploidies, deletions, duplications) between KaryoSolver and reference methods | through study completion, an average of 1 year | ClinicalTrials.gov | |
| Primary | Percentage of cases correctly classified by KaryoSolver compared to the reference comparator | through study completion, an average of 1 year | ClinicalTrials.gov | |
| Secondary | Intra-run reproducibility of KaryoSolver, assessed as the agreement of results obtained from replicates analyzed in the same session | through study completion, an average of 1 year | ClinicalTrials.gov | |
| Secondary | Inter-run reproducibility of KaryoSolver, assessed as the agreement of results obtained from replicates analyzed in different sessions | through study completion, an average of 1 year | ClinicalTrials.gov | |
| Secondary | Average analytical run time per sample with KaryoSolver compared to reference methods | through study completion, an average of 1 year | ClinicalTrials.gov | |
| Secondary | Average total reporting time/turnaround time with KaryoSolver compared to reference methods. | through study completion, an average of 1 year | ClinicalTrials.gov | |
| Secondary | Reduction in technical/interpretive workload, assessed in terms of man-hours or the number of manual tasks required | through study completion, an average of 1 year | ClinicalTrials.gov | |
| Secondary | Average cost per sample analyzed with KaryoSolver compared to reference methods | through study completion, an average of 1 year | ClinicalTrials.gov | |
| Secondary | Proportion of cases potentially eligible for faster diagnosis using KaryoSolver compared to the standard workflow | through study completion, an average of 1 year | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.