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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)


N/A
18 Years
N/A
Open (Enrolling)
Female
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

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Trial Information

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)


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.


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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

CA-IX , high-risk HPV, p16, Ki-67, and MCM2 expression in patients in North America

Outcome Description:

A logistic regression and ROC-type analysis will be performed.

Outcome Time Frame:

Baseline

Safety Issue:

No

Principal Investigator

Shu-Yuan Liao

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Institutional Review Board

Study ID:

NCI-2009-01103

NCT ID:

NCT00892866

Start Date:

February 2009

Completion Date:

Related Keywords:

  • 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
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Endometrial Hyperplasia
  • Hyperplasia
  • Papilloma
  • Virus Diseases
  • Cervical Intraepithelial Neoplasia
  • Adenoma
  • Warts
  • Uterine Cervical Dysplasia
  • Carcinoma in Situ
  • Papillomavirus Infections

Name

Location

Avera Cancer InstituteSioux Falls, South Dakota  57105
Memorial Hospital of South BendSouth Bend, Indiana  46601
University of Texas Medical BranchGalveston, Texas  77555-1329
Hartford HospitalHartford, Connecticut  06102-5037
Baystate Medical CenterSpringfield, Massachusetts  01199
William Beaumont HospitalRoyal Oak, Michigan  48073
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Elkhart General HospitalElkhart, Indiana  46515
South Bend ClinicSouth Bend, Indiana  46617
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Menorah Medical CenterOverland Park, Kansas  66209
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
North Kansas City HospitalKansas City, Missouri  64116
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Temple University HospitalPhiladelphia, Pennsylvania  19140
AnMed Health Cancer CenterAnderson, South Carolina  29621
University of California at San DiegoLa Jolla, California  92093
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
University of CincinnatiCincinnati, Ohio  45267-0502
Saint Joseph HospitalOrange, California  92868
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
Evanston CCOP-NorthShore University HealthSystemEvanston, Illinois  60201
Lakeland HospitalSt. Joseph, Michigan  49085
Saint Luke's Cancer InstituteKansas City, Missouri  64111
Saint Luke's Hospital of Kansas CityKansas City, Missouri  64111
Saint Joseph Health CenterKansas City, Missouri  64114
Liberty Radiation Oncology ClinicKansas City, Missouri  64116
Truman Medical CenterKansas City, Missouri  64108
Upstate Carolina CCOPSpartanburg, South Carolina  29303
Cancer Care Associates-YaleTulsa, Oklahoma  74136-1929
Women and Infants HospitalProvidence, Rhode Island  02905
Elkhart ClinicElkhart, Indiana  46515
Michiana Hematology Oncology PC-ElkhartElkhart, Indiana  46514
Michiana Hematology Oncology PC-PlymouthPlymouth, Indiana  46563
Michiana Hematology Oncology PC-South BendSouth Bend, Indiana  46601
Michiana Hematology Oncology-PC WestvilleWestville, Indiana  46391
Michiana Hematology Oncology PC-NilesNiles, Michigan  49120
UMDNJ - New Jersey Medical SchoolNewark, New Jersey  07103
Olive View-University of California Los Angeles Medical CenterSylmar, California  91342
Maine Medical Center-Bramhall CampusPortland, Maine  04102
Montefiore Medical Center-Weiler DivisionBronx, New York  10461
FirstHealth of the Carolinas-Moore Regional HosiptalPinehurst, North Carolina  28374
Women's Cancer Center of NevadaLas Vegas, Nevada  89109
Arizona Cancer Center at University Medical Center NorthTucson, Arizona  85719
Saint Luke's South HospitalOverland Park, Kansas  66213
Kansas City CCOPPrairie Village, Kansas  66208
Heartland Hematology and Oncology Associates IncorporatedKansas City, Missouri  64118
Saint Joseph Oncology IncSaint Joseph, Missouri  64507
Saint Francis HospitalGreenville, South Carolina  29601
Jonsson Comprehensive Cancer CenterLos Angeles, California  90095
Michiana Hematology Oncology PC-MishawakaMishawaka, Indiana  46545-1470
Marie Yeager Cancer CenterSaint Joseph, Michigan  49085
Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350
Saint Joseph Regional Medical Center-MishawakaMishawaka, Indiana  46545-1470