Front Med · 2026;13:1690020 · Paired-Sample Study · China

CISENDO in Cervical Brushing vs D&C Samples for EC

Validation of a cervical CDO1/CELF4 methylation test for endometrial cancer: a prospective paired-sample comparison with intrauterine specimen
226 women (31 EIN/EC) · D&C AUC 0.929 (Se 93.5/Sp 92.3) · CBC AUC 0.916 · CDO1 R 0.86, CELF4 R 0.78 · no method difference (P=0.244)
Cai B, Wang Y, Ma W, Wu Z, Yao T, Liu P, Wang L, Zhou P, Li Y
Gansu Provincial Maternity & Child Care Hospital · Front Med 2026;13:1690020 · doi:10.3389/fmed.2026.1690020
226
paired (31 EIN/EC)
0.929
AUC · D&C
0.916
AUC · CBC
R 0.86
CDO1 agreement

1Background & Objective

  • Question: can non-invasive cervical brushing cells (CBC) match invasive D&C samples for CISENDO?
  • Objective: validate CDO1/CELF4 for EIN+EC with paired CBC vs D&C specimens.

2Study Design & Cohort

31
EIN or EC
195
benign
2023.7–24.6
enrollment
  • Design: prospective paired; CBC + D&C from each woman, Gansu MCH.
  • Assay: CISENDO® (CDO1/CELF4 methylation, ΔCt ≤8.4/≤8.8) on both samples.
  • Reference: histopathology (EIN/EC gold standard).
  • Agreement: Spearman correlation + Bland-Altman; ROC comparison.
  • IRB: 2023-GSFY-56 · STARD-compliant.
0.929
D&C AUC
0.916
CBC AUC
P=0.244
ROC difference ns
ΔCt ↓
EIN/EC vs benign (P<0.0001)
8.4/8.8
ΔCt cut-offs
  • Inclusion: >18 y, hysteroscopy/uterine surgery indication, consent.
  • Exclusion: pregnancy · hysterectomy history · incomplete data.
  • Statistics: paired t-test · Spearman · Bland-Altman · ROC (DeLong).
  • Reporting: STARD 2015.
CISENDO CBC
AUC 0.916
CISENDO D&C
AUC 0.929
CA125
0.593
ET (TVS)
0.499
ET AUC 0.499 · CA125 AUC 0.593 — methylation far superior to conventional markers; CBC vs D&C ROC ns (P=0.244).

3CBC–D&C Agreement

R 0.86
CDO1 (P=1.3e-09)
R 0.78
CELF4 (P=2.3e-07)
no bias
Bland-Altman (P=0.14/0.41)
  • High concordance: CBC mirrors intrauterine samples for both genes.
  • No systematic bias: paired t-test ns — sampling method interchangeable.

4ROC — CBC vs D&C

ROC comparisons CBC vs D&C
Fig. ROC — CISENDO CBC vs D&C (P=0.244); single genes ns (0.744/0.777).
0.929
D&C AUC
0.916
CBC AUC
93.5%
Se · D&C
92.3%
Sp · D&C
  • Non-inferior CBC: cervical brushing matches invasive sampling accuracy.
  • Versus markers: methylation ≫ ET (0.499) & CA125 (0.593).

5Why It Matters

  • Barrier removal: painless CBC collection overcomes D&C discomfort & compliance issues.
  • Integration: fits existing cervical cancer screening programs.
  • Early detection: EIN (precancer) included — intervention before EC.
  • Direction: non-invasive triage for high-risk / symptomatic women.
31
EIN/EC
226
paired samples
93.5%
Se · D&C
CISENDO on CBC: highly accurate, reliable, non-invasive — potentially transformative for EC early detection and triage of high-risk women.
Clinical Significance