Trial · NCT07885163
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Distribution of primary gonadal phenotype in patients with 46,XX/47,XXY mosaicism | Baseline | number and percentage of participants according to primary gonadal phenotype: * bilateral testicles * unilateral testicles * unilateral ovary * unilateral or bilateral ovotestis |
| Secondary | Correlation between XX cell-line percentage and final height within the mKS-XX cohort | Baseline | Spearman's rank correlation analysis assessing the correlation between the percentage of 46,XX cells and final adult height. The percentage of 46,XX cells (%) was determined by conventional cytogenetic karyotyping, supplemented by fluorescence in situ hybridization (FISH) when available. Final adult height was obtained from clinical records and defined by a difference of less than 1 cm between two consecutive height measurements at least 6 months apart. Final height will be reported in meters. The correlation coefficient is dimensionless. Time Frame: Baseline |
| Secondary | Between-group difference in adult height (mKS-XX vs non-mosaic KS) | Baseline | Comparison of adult height between patients with mKS-XX and patients with non-mosaic Klinefelter syndrome, using the most recent available assessment at study inclusion. Adult height will be reported in meters. |
| Secondary | Between-group difference in body mass index (mKS-XX vs non-mosaic KS) | Baseline | Comparison of body mass index between patients with 46,XX/47,XXY mosaicism and patients with non-mosaic Klinefelter syndrome, using the most recent available assessment at study inclusion. BMI will be reported in kg/m². |
| Secondary | Between-group difference in gonadal phenotype (mKS-XX vs non-mosaic KS) | Baseline | Comparison of gonadal phenotype between patients with 46,XX/47,XXY mosaicism and patients with non-mosaic Klinefelter syndrome. Gonadal phenotype will include the presence of DSD and ovarian or ovotesticular tissue and will be reported as number and percentage of participants. |
| Secondary | Between-group difference in testicular volume (mKS-XX vs non-mosaic KS) | Baseline | Comparison of testicular volume between patients with 46,XX/47,XXY mosaicism and patients with non-mosaic Klinefelter syndrome, using the most recent available assessment at study inclusion. Testicular volume will be reported in mL. |
| Secondary | Between-group difference in LH levels (mKS-XX vs non-mosaic KS) | Baseline | Comparison of serum luteinizing hormone levels between patients with 46,XX/47,XXY mosaicism and patients with non-mosaic Klinefelter syndrome, using the most recent available measurement at study inclusion. LH will be reported in IU/L. |
| Secondary | Between-group difference in FSH levels (mKS-XX vs non-mosaic KS) | Baseline | Comparison of serum follicle-stimulating hormone levels between patients with 46,XX/47,XXY mosaicism and patients with non-mosaic Klinefelter syndrome, using the most recent available measurement at study inclusion. FSH will be reported in IU/L. |
| Secondary | Between-group difference in testosterone levels (mKS-XX vs non-mosaic KS) | Baseline | Comparison of serum testosterone levels between patients with 46,XX/47,XXY mosaicism and patients with non-mosaic Klinefelter syndrome, using the most recent available measurement at study inclusion. Testosterone will be reported in ng/mL. |
| Secondary | Between-group difference in educational level (mKS-XX vs non-mosaic KS) | Baseline | Comparison of educational level between patients with 46,XX/47,XXY mosaicism and patients with non-mosaic Klinefelter syndrome. Educational level was assessed from medical records according to the French and Belgian educational systems, using four categories: illiterate/no schooling, CAP/BAC, professional training, and bachelor's degree or higher. Results will be reported as numbers and percentages of participants in each category. |
| Secondary | Correlation between XX cell-line percentage and delta height within the mKS-XX cohort | Baseline | Spearman's rank correlation analysis assessing the correlation between the percentage of 46,XX cells and delta height. The percentage of 46,XX cells (%) was determined by conventional cytogenetic karyotyping, supplemented by FISH when available. Delta height was defined as the difference between final adult height and mid-parental target height, calculated using the Tanner formula. Delta height will be reported in meters. The correlation coefficient is dimensionless. |
| Secondary | Correlation between XX cell-line percentage and educational level within the mKS-XX cohort | Baseline | Spearman's rank correlation analysis assessing the correlation between the percentage of 46,XX cells and educational level. The percentage of 46,XX cells (%) was determined by conventional cytogenetic karyotyping, supplemented by FISH when available. Educational level was obtained from medical records and assessed according to the French and Belgian educational systems, using categories of educational attainment. Educational level is a categorical variable, and the correlation coefficient is dimensionless. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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