Clinical trial · Interventional
CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells
Comparative Analysis of CA-IX, p16, Proliferative Markers, and Human Papilloma Virus (HPV) in the Diagnosis of Significant Cervical Lesions in Patients With a Cytologic Diagnosis of Atypical Glandular Cells (AGC)
NCT00892866CI-TRIAL-00076736unknownN/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 research trial studies carbonic anhydrase 9 (CA-IX), p16, proliferative markers, and human papilloma virus (HPV) in diagnosing cervical lesions in patients with abnormal cervical cells. Studying biomarkers in abnormal cervical cells may improve the ability to find cervical lesions and plan effective treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypical Endometrial Hyperplasia | Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia | ALIAS | 0.90 |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
| Stage 0 Cervical Cancer AJCC v7 | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Ancillary-Correlative (biomarkers in cervical cancer)
- description
- Patients undergo liquid-based cytology specimen sample collection for analysis of CA-IX, p16, Ki-67, and MCM2 expression via IHC and for the presence of high risk HPV DNA and HPV genotyping.
- interventionNames
- Other: Cytology Specimen Collection Procedure
- Other: Laboratory Biomarker Analysis
Primary outcomes (3)
- measure
- Biomarker expression in patients from North America
- timeFrame
- Baseline
- description
- CA-IX, p16, Ki-67, and MCM2 expression in LBC specimens is measured via IHC. A logistic regression and receiver operating characteristic (ROC)-type analysis will be performed.
- measure
- Biomarker expression in patients from Japan
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a cytologic diagnosis of AGC (AGC, atypical endocervical cells \[AEC\], atypical endometrial cells \[AEmC\]) or a cytologic/histologic diagnosis of AIS documented within the last 6 months who can wait at least one week after the AGC or AIS diagnosis to have an LBC specimen (i.e., ThinPrep) collected and then receive any other intervention; acceptable time frame range is 4 days prior to registration to 7 days after registration * Patients with positive HPV results who are willing to undergo a complete histologic examination of the uterus and cervix, including the cervical transformation zone, within 6 months of the AGC or AIS diagnosis (histologic examination includes a loop electrosurgical excision procedure \[LEEP\], loop excision of the transformation zone \[LETZ\], excisional cone biopsy, or hysterectomy) * Patients must have signed an approved informed consent and authorization permitting release of personal health information Exclusion Criteria: * Patients who have had a hysterectomy * History of endometrial hyperplasia or cancer of the endometrium, vagina, or cervix * Patients who have previously been treated, or are currently being treated with radiation therapy or chemotherapy for vaginal or cervical cancer * Patients who are known to be human immunodeficiency virus (HIV)-positive * Patients who are pregnant and thought to be at risk for excessive bleeding or preterm labor if a cone biopsy is performed
References
Publications (0)
Data not yet available
No reference posted for this study.