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Atypical Endometrial HyperplasiaNCT00892866

CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells

A study testing Cytology Specimen Collection Procedure and Laboratory Biomarker Analysis in people with Atypical Endometrial Hyperplasia and Human Papillomavirus Infection, run by GOG Foundation at 163 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Cytology Specimen Collection Procedure and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
877 participants
Where
163 sitesin 3 countries
Study dates
13 Apr 2009to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

163 sites in 3 countries.

163 sites in 3 countries

United States135 sites

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Saint Alphonsus Medical Center-Baker City

    Baker City, Oregon, 97814

  • Woman's Hospital

    Baton Rouge, Louisiana, 70817

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Big Horn Basin Cancer Center

    Cody, Wyoming, 82414

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Central Ohio Breast and Endocrine Surgery

    Gahanna, Ohio, 43230

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Providence Medical Center

    Kansas City, Kansas, 66112

  • Truman Medical Centers

    Kansas City, Missouri, 64108

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Saint Joseph Health Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Heartland Hematology and Oncology Associates Incorporated

    Kansas City, Missouri, 64118

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89106

  • UTMB Cancer Center at Victory Lakes

    League City, Texas, 77573

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Kansas Institute of Medicine Cancer and Blood Center

    Lenexa, Kansas, 66219

  • Minimally Invasive Surgery Hospital

    Lenexa, Kansas, 66219

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Liberty Radiation Oncology Center

    Liberty, Missouri, 64068

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

  • Michiana Hematology Oncology PC-Mishawaka

    Mishawaka, Indiana, 46545

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Community Medical Hospital

    Missoula, Montana, 59804

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Saint Alphonsus Medical Center-Nampa

    Nampa, Idaho, 83686

  • Norris Cotton Cancer Center-Nashua

    Nashua, New Hampshire, 03063

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Newark Radiation Oncology

    Newark, Ohio, 43055

  • Lakeland Hospital Niles

    Niles, Michigan, 49120

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Saint Alphonsus Medical Center-Ontario

    Ontario, Oregon, 97914

  • Saint Joseph Hospital - Orange

    Orange, California, 92868

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Michiana Hematology Oncology PC-Plymouth

    Plymouth, Indiana, 46563

  • Maine Medical Center-Bramhall Campus

    Portland, Maine, 04102

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania, 17901

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Lakeland Medical Center Saint Joseph

    Saint Joseph, Michigan, 49085

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Saint Joseph Oncology Inc

    Saint Joseph, Missouri, 64507

  • Kootenai Cancer Clinic

    Sandpoint, Idaho, 83864

  • Maine Medical Center- Scarborough Campus

    Scarborough, Maine, 04074

  • Community Medical Center

    Scranton, Pennsylvania, 18510

  • Geisinger Medical Oncology-Selinsgrove

    Selinsgrove, Pennsylvania, 17870

  • Advent Health - Shawnee Mission Medical Center

    Shawnee Mission, Kansas, 66204

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Michiana Hematology Oncology PC-South Bend

    South Bend, Indiana, 46601

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Olive View-University of California Los Angeles Medical Center

    Sylmar, California, 91342

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • Michiana Hematology Oncology PC-Westville

    Westville, Indiana, 46391

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Genesis Healthcare System Cancer Care Center

    Zanesville, Ohio, 43701

Other trials in United States

Japan17 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Kagoshima City Hospital

    Kagoshima, Kagoshima-ken, 890-8760

  • Kure National Hospital

    Kure, Hiroshima, 737

  • Shikoku Cancer Center

    Matsuyama, 791-0280

  • National Kyushu Cancer Center

    Minamiku, 811 1395

  • Jikei University School of Medicine

    Minato-ku, Tokyo, 105-8461

  • University of the Ryukyus Hospital-Col Health Scnc

    Nakagami-gun, Okinawa, 903-0215

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata, 951-8520

  • Kindai University

    Osaka, 589 8511

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tohoku University School of Medicine

    Sendai, Aoba-ku, 980-8574

  • Keio University

    Shinjuku-ku, Tokyo, 160-8582

  • Iwate Medical University Hospital

    Shiwa-gun, Iwate, 028-3695

  • National Cancer Center Hospital

    Tokyo, 104 0045

  • Tottori University

    Tottori, 680-8550

Other trials in Japan

South Korea11 sites

  • Keimyung University-Dongsan Medical Center

    Dalseo-gu, Daegu, 42601

  • National Cancer Center-Korea

    Goyang-si, Gyeonggi-do, 410-769

  • Gachon University Gil Hospital

    Incheon, 405-760

  • Inha University

    Jung-gu, Incheon, 400-711

  • Seoul National University Bundang Hospital

    Seongnam, Kyeonggi-do, 463-707

  • Catholic University of Korea-Seoul Saint Mary's Hospital

    Seoul, Korea, 137-040

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Seoul National University Hospital

    Seoul, 110-744

  • Yonsei University Health System-Severance Hospital

    Seoul, 120-752

  • Kyung Hee University Hospital at Gangdong

    Seoul, 134-727

Other trials in South Korea

About this study

Official title: 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)

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To examine CA-IX, p16, Ki-67, and mini-chromosome maintenance complex component 2 (MCM2) expression in liquid-based cytology (LBC) specimens to see which subset of markers can provide the optimal diagnosis of significant cervical lesions in women in North America with a cytologic diagnosis of atypical glandular cells (AGC) and a positive test for high risk human papillomavirus (HPV).

II. To examine high risk HPV, CA-IX, p16, Ki-67, and MCM2 expression in LBC specimens to see which subset of markers can provide the optimal diagnosis of significant cervical lesions in women in Japan and Korea (with each country's cohort analyzed separately) with a cytologic diagnosis of AGC.

SECONDARY OBJECTIVES:

  1. To determine whether the accuracy of diagnosis based on high risk HPV and expression of CA-IX, p16, Ki-67, and/or MCM2 varies with patient age at enrollment and country of enrollment.

TERTIARY OBJECTIVES:

  1. To assess biomarker expression, loss of heterozygosity, and chromosome gains/losses in formalin-fixed, paraffin-embedded tissue from the highest grade or most abnormal lesion in women from North America, Japan, or Korea presenting with a cytologic diagnosis of AGC or with a cytologic/histologic diagnosis of adenocarcinoma in situ (AIS).

II. To determine CA-IX, p16, Ki67, and MCM2 expression in LBC specimens to see which subset (or combination) of markers will provide higher sensitivity in the diagnosis of cervical adenocarcinoma in situ (AIS).

OUTLINE:

Patients undergo liquid-based cytology specimen sample collection for analysis of CA-IX, p16, Ki-67, and MCM2 expression via immunohistochemistry (IHC) and for the presence of high risk HPV deoxyribonucleic acid (DNA) and HPV genotyping.

Being tested
Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis
Medical subject headings
Endometrial Hyperplasia, Papillomavirus Infections, Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cytology Specimen Collection ProcedureOther

    Also called Cytologic Sampling

    Correlative studies

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT00892866
Study groupRoleWhat they receive
Ancillary-Correlative (biomarkers in cervical cancer)OtherPatients 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.
Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biomarker expression in patients from North America

    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.

    Measured: Baseline

  2. Biomarker expression in patients from Japan

    CA-IX, p16, Ki-67, and MCM2 expression in LBC specimens is measured via IHC. A logistic regression and ROC-type analysis will be performed.

    Measured: Baseline

  3. Biomarker expression in patients from Korea

    CA-IX, p16, Ki-67, and MCM2 expression in LBC specimens is measured via IHC. A logistic regression and ROC-type analysis will be performed.

    Measured: Baseline

Secondary outcomes (2)

  1. Effect of patient age on the accuracy of diagnosis based on CA-IX, HPV, p16, Ki-67, and/or MCM2 expression in the North American population

    Logistic regression analyses will be performed to assess the effect of age and country on sensitivity, specificity, false positive rate (FPR), and complement negative predictive value (NPVC.). For each country and at each age, an upper 95% confidence limit will be calculated for the NPVC.

    Measured: Baseline

  2. Effect of patient age on the accuracy of diagnosis based on CA-IX, HPV, p16, Ki-67, and/or MCM2 expression in the Korean and Japanese populations

    Logistic regression analyses will be performed to assess the effect of age and country on sensitivity, specificity, FPR, and NPVC. For each country and at each age, an upper 95% confidence limit will be calculated for the NPVC.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2009 (estimated)
  2. Study start13 Apr 2009
  3. Primary completion31 May 2025 (estimated)
  4. Study completion31 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
877 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00892866
Sponsor's protocol ID
GOG-0237
Other IDs
NCI-2009-01103, CDR0000632236, GOG-0237, GOG-0237, GOG-0237, N01CM62201, U10CA101165, UG1CA189867
Status last verified
May 2024
First submitted
2 May 2009
Last updated
3 May 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Cytology Specimen Collection Procedure and Laboratory Biomarker Analysis in people with Atypical Endometrial Hyperplasia and Human Papillomavirus Infection, run by GOG Foundation at 163 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 163 sites in United States, Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biomarker expression in patients from North America (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00892866.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.

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