Gynecol Oncol · 2026 · Prospective Cohort · China

CDO1/CELF4 Methylation as Dominant Endometrial Cancer Predictor

CDO1 与 CELF4 甲基化检测是子宫内膜癌的主导预测因子——绝经前后队列分析
573 hysteroscopy-referred women (41 EC + 8 EIN) · pre-meno Se 89.7%/AUC 0.91 · post-meno Se 91.7%/AUC 0.92 · adjusted OR 103.9/118.0
Wang X, Zheng L, Zhu G, Wang S, Li W, Liu J, Gao H, Liu X, Li G, Li L, Hong L
Hainan General Hospital · Peking Union Medical College Hospital · 2026
573
hysteroscopy-referred
89.7%
Se · premenopausal
91.7%
Se · postmenopausal
OR 103.9
strongest predictor

1Background & Objective

  • Problem: EC incidence rising; no general screening; TVS/ET thresholds unreliable, esp. premenopausal.
  • Objective: evaluate CISENDO (CDO1/CELF4 methylation) ± endometrial thickness (ET) for EC triage.

2Study Design & Cohort

524
non-EC
41
EC
8
EIN
  • Setting: Hainan General Hospital; prospective, Jan–Jun 2022; hysteroscopy-referred.
  • Assay: CDO1/CELF4 methylation (CISENDO) on cervical scrapings + TVS ET.
  • Analysis: stratified by menopause; univariate & multivariate logistic (aOR).
  • EC profile: 92.7% endometrioid; 70.7% FIGO stage I — early-stage detection.
608
enrolled
573
analyzed
2022.1–6
enrollment
  • Inclusion: ≥18 y, hysteroscopy indication, informed consent.
  • Exclusion: incomplete data · prior gynecologic cancer · hysterectomy · pregnancy.
  • Readout: ΔCt cut-offs — CDO1 8.4 · CELF4 8.8.
  • Menopause: amenorrhea ≥12 months (guideline-based).
aOR · premenopausal
103.9
aOR · postmenopausal
118.0
  • OR rule (either positive): max sensitivity — Se 96.6%/100%.
  • AND rule (both positive): max specificity — Sp 97.2%/98.0%.
  • NPV >90% across most combinations — safe deferral.
ET alone (premenopausal)
AUC 0.57
CISENDO + ET (co-test)
AUC 0.83
  • Ultrasound limitation: ET alone AUC 0.57 — methylation co-test lifts to 0.83.
Methylation was the strongest independent EC predictor vs all clinical/ultrasound factors (P<0.001).

3Performance by Menopausal Status

Premenopausal
89.7%
Se
93.0%
Sp
0.91
AUC
+ ET ≥11 mm
Se 96.6%
  • 55.2% EC: ET <11 mm yet CISENDO(+) — catches what ultrasound misses.
Postmenopausal
91.7%
Se
91.8%
Sp
0.92
AUC
+ ET ≥5 mm
Se 100%
  • 52.7% non-EC: ET ≥5 mm yet CISENDO(−) — cuts false alarms.

4Methylation–TVS Concordance

Methylation-TVS concordance across menopausal status
Fig. Methylation–TVS concordance — risk-stratification across pre/postmenopausal groups.
97.2%
pre non-EC ruled out
92.9%
post non-EC ruled out
53.1%
post ET ≥5 mm · CISENDO(−)
23.9%
pre ET ≥11 mm · CISENDO(−)
  • Few misclassified: isolated methylation+ with thin ET only 4.2% (pre) / 1.0% (post).
  • Corrects ultrasound: methylation clears ET-driven false positives & negatives.
Clinical Significance