Clinical trial · Interventional
Protein Expression as a Potential Diagnostic Biomarker of Cervical Dysplasia and/or Cancer
Expression of the MN Protein in Atypical Glandular Cells of Undetermined Significance (Agus or Agcus) As a Potential Diagnostic Biomarker of Cervical Dysplasia/Neoplasia
NCT00003384CI-TRIAL-00018086completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This diagnostic trial is studying the presence of a specific protein as a potential biomarker of cervical dysplasia and/or cancer. The presence of specific proteins may allow a doctor to determine whether a patient has cervical dysplasia and/or cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precancerous Condition | — | UNRESOLVED | — |
| Stage 0 Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervical Papanicolaou Test | Other | — | UNRESOLVED |
| Conization | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic
- description
- Patients undergo a Pap smear followed by a ThinPrep cervical cell specimen collection at the time of direct colposcopic examination. Patients then undergo a cone biopsy of the cervix using loop electrosurgical excision procedure with an endocervical curettage, an excisional cone biopsy of the cervix with or without endocervical curettage, or a hysterectomy. Patients who are perimenopausal or postmenopausal or have a negative cervical cone biopsy also undergo endometrial biopsy or curettage. The Pap smear specimen is analyzed to determine MN antigen expression and the ThinPrep specimen is analyzed for the presence of high-risk human papilloma virus and to determine MN antigen and other marker (e.g., P16) expression. Patients who do not undergo hysterectomy are followed every 6 months for 2 years. All other patients are followed at 4, 26, and 30 weeks.
- interventionNames
- Other: Cervical Papanicolaou Test
- Procedure: Conization
- Other: Laboratory Biomarker Analysis
Primary outcomes (2)
- measure
- Expression of the MN antigen in cytologic preparations that have been classified as AGUS
- timeFrame
- Baseline
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologically confirmed atypical glandular cells of undetermined significance (AGUS) * Must be scheduled to undergo complete histologic examination of the cervix by cone biopsy using loop electrosurgical excision procedure with an endocervical curettage, excisional cone biopsy with or without endocervical curettage, or hysterectomy within 6 months of the initial cytologic diagnosis of AGUS * No history of endometrial hyperplasia * No history of cancer of the endometrium, vagina, or cervix * HIV negative * No pregnant patients who are at high risk for excessive bleeding or preterm labor if a cone biopsy is performed * No prior cytotoxic chemotherapy for vaginal and/or cervical cancer * No prior radiotherapy to the vagina or cervix * No concurrent radiotherapy to the vagina or cervix * No prior hysterectomy
References
Publications (0)
Data not yet available
No reference posted for this study.