Diagnostic and recurrence or progression risk assessment value of human ASTN1, DLX1, ITGA4, RXFP3, SOX17, and ZNF671 gene methylation assays for ductal carcinoma in situ (AIS) of the uterine cervix and adenocarcinoma of the cervix

The value of human ASTN1, DLX1, ITGA4, RXFP3, SOX17, and ZNF671 gene methylation assays for the diagnosis and risk assessment of recurrence or progression of cervical ductal carcinoma in situ (AIS) and cervical adenocarcinoma: a multicenter, prospective, observational clinical study

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400088167

Enrollment

Unknown

Registered

2024-08-13

Start date

2024-12-16

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma in situ of the cervix and adenocarcinoma of the cervix

Interventions

Gold Standard:HPV testing, cytology examination, vaginal colposcopy biopsy

Index test:Methylation detection of ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria Samples that meet all the inclusion criteria of (1) (2) (3) will be enrolled in this trial: (1) Subjects from whom cervical exfoliated cell samples can be collected; (2) Patients who meet cytologic AGC, AIS, and can be biopsied for in situ adenocarcinoma sites are included in the study; (3) Subjects who are compliant and voluntarily participate in the trial and sign informed consent.

Exclusion criteria

Exclusion criteria: Exclusion Criteria Subjects meeting any of the following criteria will be excluded: 1) Patients without cervical exfoliative cells; 2) Patients with combined gynecologic and other malignancies; 3) Those with abnormal liver or renal function or other serious systemic diseases that cannot tolerate the procedure.

Design outcomes

Primary

Measure	Time frame
Clinical sensitivity ;clinical specificity ;	—

Countries

China

Contacts

Public ContactLong Sui

The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)

suilongdoc@sina.com+86 138 0178 8118

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026