J Lanzhou Univ (Med Sci) · 2024(07) · Screening Study · China

CISENDO Dual-Gene Methylation for EC Screening in AUB

禾蔻安双基因甲基化检测在子宫内膜癌筛查中的应用价值
216 AUB women · CISENDO Se 91.2% / Sp 96.7% · CELF4m OR 60.995 · beats ultrasound & CA125
Cai B, Li L, Liu B, Liu P, Wang L, Wang Y, Liu Y, Wang Z, Du J
Gansu MCH Hospital · Beijing Origin-Poly Bio-Tec · Guangdong Pharma Univ · J Lanzhou Univ (Med Sci) 2024(07)
216
AUB women
91.2%
Se · CISENDO
96.7%
Sp · CISENDO
OR 60.995
CELF4m

1Background & Objective

  • Problem: AUB common but EC rare; ultrasound & CA125 cannot confirm EC; invasive hysteroscopy over-used.
  • Objective: value of CISENDO (CDO1/CELF4) dual-gene methylation for EC screening in AUB.

2Study Design & Cohort

216
AUB hysteroscopy
2021.7–22.6
enrollment
histology
gold standard
  • Setting: Gansu MCH hysteroscopy clinic; cervical cells → CDO1/CELF4 methylation.
  • Comparators: ultrasound (ET) & serum CA125.
  • Univariate: age (P=0.001) · BMI (P=0.002) · diabetes (P=0.012) · menopause (P<0.001) · methylation (P<0.001).
  • Multivariate: BMI OR 3.970 · menopause OR 18.702 · CDO1m OR 22.351 · CELF4m OR 60.995.
91.2%
Se (76.3–98.1)
96.7%
Sp (93.0–98.8)
60.995
CELF4m OR
91.2%
Se · CISENDO
55.9%
Se · US
32.4%
Se · CA125
  • Inclusion: AUB women at Gansu MCH hysteroscopy clinic; complete data.
  • Exclusion: prior treatment · other malignancy · invalid samples.
  • Statistics: univariate + binary logistic (OR) · Se/Sp/PPV/NPV/AUC.
  • Focus: postmenopausal women — highest screening value.
60.995
CELF4m OR
22.351
CDO1m OR
18.702
menopause OR
  • Missed-diagnosis risk: many AUB women avoid hysteroscopy — delay EC diagnosis.
  • Invasive risks: perforation · adhesion · infection — avoided by methylation triage.
Funded: Lanzhou Sci-Tech Bureau 2022-5-92 · Gansu NSF 23JRRA1380; CISENDO outperforms US & CA125 across Se/Sp.

3Risk Factors — OR Comparison

CELF4m
OR 60.995
CDO1m
OR 22.351
Menopause
OR 18.702
BMI
OR 3.970
  • Methylation leads: CELF4m OR 60.995 (5.99–620.92) — dominant EC risk signal.

4ROC & Head-to-Head

ROC curves CISENDO vs ultrasound vs CA125
Fig. ROC — CISENDO dual-gene vs ultrasound & CA125.
91.2%
Se · CISENDO
96.7%
Sp · CISENDO
55.9%
Se · US
32.4%
Se · CA125
  • Clear superiority: methylation ≫ ultrasound & CA125 for EC screening.
  • Postmenopausal: highest value — flags high-risk women.

5Three-Method Performance

CISENDO Se
91.2%
CISENDO Sp
96.7%
US Se
55.9%
US Sp
78.6%
CA125 Se
32.4%
CA125 Sp
76.4%
  • Non-invasive screening: dual-gene methylation best balances Se & Sp.
  • Reduces invasive burden: fewer unnecessary hysteroscopies/biopsies.
Clinical Significance