Studying Biomarkers in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00892866
First received: May 2, 2009
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

This clinical trial is studying biomarkers 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.


Condition Intervention
Atypical Endocervical Glandular Cell of Undetermined Significance
Atypical Endometrial Hyperplasia
Atypical Glandular Cell of Undetermined Significance
Cervical Cancer
Cervical Intraepithelial Neoplasia Grade 2
Cervical Intraepithelial Neoplasia Grade 3
Human Papilloma Virus Infection
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Observational - 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)

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • CA-IX , high-risk HPV, p16, Ki-67, and MCM2 expression in patients in North America [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A logistic regression and ROC-type analysis will be performed.

  • CA-IX , high-risk HPV, p16, Ki-67, and MCM2 expression in patients in Japan [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A logistic regression and ROC-type analysis will be performed.


Secondary Outcome Measures:
  • Effect of patient age and country (North America or Japan) on the accuracy of diagnosis based on CA-IX, HPV, p16, Ki-67, and/or MCM2 expression [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Logistic regression analyses will be performed.

  • Inter- and intra-reviewer reproducibility of scoring CA-IX, p16, Ki-67 and MCM2 biomarkers [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Logistic regression analyses will be performed.


Estimated Enrollment: 754
Study Start Date: February 2009
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Basic science (correlative studies)
Liquid-based cytology specimens are collected within 1 week of study entry (prior to colposcopy examination and/or any surgical procedure). Specimens are analyzed for CA-IX, p16, Ki-67, and MCM2 expression by immunohistochemistry assays and for the presence of high-risk HPV by Digene Hybrid Capture II HPV testing and Roche Linear Array HPV genotyping.
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

Study Subtype: Ancillary/Correlative Observational Study Model: Case-only Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Primary care clinic Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVES:

I. To examine the expression of CA-IX, high-risk human papilloma virus (HPV), p16, Ki-67, and MCM2 in liquid-based cytology (LBC) specimens to determine which subset of markers will provide the optimal diagnosis of significant cervical lesions in patients in North America with atypical glandular cells (AGC).

II. To examine the expression of CA-IX, high-risk HPV, p16, Ki-67, and MCM2 in LBC specimens to determine which subset of markers will provide the optimal diagnosis of significant cervical lesions in patients in Japan with AGC.

SECONDARY OBJECTIVES:

I. To determine whether the accuracy of diagnosis based on CA-IX, HPV, p16, Ki-67, and/or MCM2 expression varies with patient age at study enrollment and country of enrollment (North American or Japan).

II. To assess the inter- and intra-reviewer reproducibility of scoring CA-IX, p16, Ki-67, and MCM2.

OUTLINE: This is a multicenter study.

Patients undergo a cone biopsy of the cervix by loop electrosurgical excision procedure (LEEP)* with or without endocervical curettage, an excisional cone biopsy* of the cervix with or without endocervical curettage, or a hysterectomy within 6 months after the initial cytologic diagnosis of atypical glandular cells (AGC). A complete histological examination of the cervix, including the transformation zone is performed.

NOTE: *Patients 35 years of age with negative cervical LEEP or excisional cone biopsy must undergo endometrial biopsy or curettage.

Liquid-based cytology specimens are collected within 1 week of study entry (prior to colposcopy examination and/or any surgical procedure). Specimens are analyzed for CA-IX, p16, Ki-67, and MCM2 expression by immunohistochemistry assays and for the presence of high-risk human papilloma virus (HPV) by Digene Hybrid Capture II HPV testing and Roche Linear Array HPV genotyping.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with cytologic diagnosis of AGC

Criteria

Inclusion Criteria:

  • Cytologically confirmed atypical glandular cells (AGC), including any of the following types:

    • AGC of unclear cell origin
    • Atypical endocervical cells (AEC)
    • Atypical endometrial cells (AEmC)
  • Must be able to wait ≥ 1 week after initial AGC diagnosis before beginning intervention
  • No history of endometrial hyperplasia or cancer of the endometrium, vagina, or cervix
  • No known HIV positivity
  • Not pregnant
  • Negative pregnancy test
  • No prior hysterectomy
  • No prior or concurrent radiotherapy or chemotherapy for vaginal or cervical cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892866

  Show 81 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Shu-Yuan Liao Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00892866     History of Changes
Other Study ID Numbers: GOG-0237, GOG-0237, NCI-2009-01103, CDR0000632236, U10CA101165
Study First Received: May 2, 2009
Last Updated: August 1, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Papilloma
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Endometrial Hyperplasia
Hyperplasia
Neoplasms
Papillomavirus Infections
Uterine Cervical Dysplasia
Uterine Cervical Neoplasms
Virus Diseases
Carcinoma
DNA Virus Infections
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Pathologic Processes
Precancerous Conditions
Tumor Virus Infections
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014