Last updated on March 2019

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


Brief description of study

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.

Detailed Study Description

PRIMARY OBJECTIVES:

I. 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:

I. 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:

I. 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.

Clinical Study Identifier: NCT00892866

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University of Arizona Cancer Center-North Campus
Tucson, AZ United States
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Shu-Yuan Liao

The University of Arizona Medical Center-University Campus
Tucson, AZ United States
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Scott E. Lentz

Kaiser Permanente Los Angeles Medical Center
Los Angeles, CA United States
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, CA United States
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Shu-Yuan Liao

Saint Joseph Hospital - Orange
Orange, CA United States
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Krishnansu S. Tewari

UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, CA United States
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Michael T. McHale

University of California San Diego
San Diego, CA United States
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Olive View-University of California Los Angeles Medical Center
Sylmar, CA United States
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Hartford Hospital
Hartford, CT United States
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The Hospital of Central Connecticut
New Britain, CT United States
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Benjamin T. Marchello

Kootenai Medical Center
Coeur d'Alene, ID United States
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Benjamin T. Marchello

Kootenai Cancer Center
Post Falls, ID United States
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Benjamin T. Marchello

Kootenai Cancer Clinic
Sandpoint, ID United States
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NorthShore University HealthSystem-Evanston Hospital
Evanston, IL United States
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Good Samaritan Regional Health Center
Mount Vernon, IL United States
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Elkhart Clinic
Elkhart, IN United States
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Michiana Hematology Oncology PC-Elkhart
Elkhart, IN United States
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Elkhart General Hospital
Elkhart, IN United States
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Community Howard Regional Health
Kokomo, IN United States
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IU Health La Porte Hospital
La Porte, IN United States
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Michiana Hematology Oncology PC-Mishawaka
Mishawaka, IN United States
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Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, IN United States
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Michiana Hematology Oncology PC-Plymouth
Plymouth, IN United States
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Memorial Hospital of South Bend
South Bend, IN United States
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Michiana Hematology Oncology PC-South Bend
South Bend, IN United States
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South Bend Clinic
South Bend, IN United States
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Michael Rodriguez

Northern Indiana Cancer Research Consortium
South Bend, IN United States
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Michiana Hematology Oncology PC-Westville
Westville, IN United States
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Providence Medical Center
Kansas City, KS United States
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Kansas Institute of Medicine Cancer and Blood Center
Lenexa, KS United States
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Minimally Invasive Surgery Hospital
Lenexa, KS United States
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Menorah Medical Center
Overland Park, KS United States
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Saint Luke's South Hospital
Overland Park, KS United States
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Kansas City NCI Community Oncology Research Program
Prairie Village, KS United States
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M. G. Fort

Woman's Hospital
Baton Rouge, LA United States
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Maine Medical Center-Bramhall Campus
Portland, ME United States
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Laurie A. Small

Maine Medical Center- Scarborough Campus
Scarborough, ME United States
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Tashanna K. Myers

Baystate Medical Center
Springfield, MA United States
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William Beaumont Hospital-Royal Oak
Royal Oak, MI United States
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Marie Yeager Cancer Center
Saint Joseph, MI United States
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Gretchen E. Glaser

Mayo Clinic
Rochester, MN United States
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Centerpoint Medical Center LLC
Independence, MO United States
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Truman Medical Center
Kansas City, MO United States
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Saint Luke's Hospital of Kansas City
Kansas City, MO United States
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Saint Joseph Health Center
Kansas City, MO United States
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North Kansas City Hospital
Kansas City, MO United States
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Heartland Hematology and Oncology Associates Incorporated
Kansas City, MO United States
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Research Medical Center
Kansas City, MO United States
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Saint Luke's East - Lee's Summit
Lee's Summit, MO United States
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Liberty Radiation Oncology Center
Liberty, MO United States
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Jay W. Carlson

Delbert Day Cancer Institute at PCRMC
Rolla, MO United States
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Heartland Regional Medical Center
Saint Joseph, MO United States
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Saint Joseph Oncology Inc
Saint Joseph, MO United States
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Jay W. Carlson

Mercy Hospital Saint Louis
Saint Louis, MO United States
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Cancer Research for the Ozarks NCORP
Springfield, MO United States
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Jay W. Carlson

Mercy Hospital Springfield
Springfield, MO United States
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Jay W. Carlson

CoxHealth South Hospital
Springfield, MO United States
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Benjamin T. Marchello

Community Hospital of Anaconda
Anaconda, MT United States
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Benjamin T. Marchello

Billings Clinic Cancer Center
Billings, MT United States
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Saint Vincent Healthcare
Billings, MT United States
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Benjamin T. Marchello

Bozeman Deaconess Hospital
Bozeman, MT United States
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Saint James Community Hospital and Cancer Treatment Center
Butte, MT United States
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Benjamin T. Marchello

Benefis Healthcare- Sletten Cancer Institute
Great Falls, MT United States
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Benjamin T. Marchello

Great Falls Clinic
Great Falls, MT United States
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Benjamin T. Marchello

Saint Peter's Community Hospital
Helena, MT United States
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Benjamin T. Marchello

Kalispell Regional Medical Center
Kalispell, MT United States
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Saint Patrick Hospital - Community Hospital
Missoula, MT United States
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Benjamin T. Marchello

Community Medical Hospital
Missoula, MT United States
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Kerry J. Rodabaugh

University of Nebraska Medical Center
Omaha, NE United States
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Nicola M. Spirtos

Women's Cancer Center of Nevada
Las Vegas, NV United States
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Leslie R. DeMars

Dartmouth Hitchcock Medical Center
Lebanon, NH United States
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Leslie R. DeMars

Norris Cotton Cancer Center-Nashua
Nashua, NH United States
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Rutgers New Jersey Medical School
Newark, NJ United States
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Jason D. Wright

Columbia University/Herbert Irving Cancer Center
New York, NY United States
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Richard G. Moore

University of Rochester
Rochester, NY United States
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Robert F. Goodlett

Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, NC United States
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Wake Forest University Health Sciences
Winston-Salem, NC United States
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Timothy D. Moore

Strecker Cancer Center-Belpre
Belpre, OH United States
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Timothy D. Moore

Adena Regional Medical Center
Chillicothe, OH United States
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University of Cincinnati/Barrett Cancer Center
Cincinnati, OH United States
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Timothy D. Moore

Mount Carmel East Hospital
Columbus, OH United States
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Timothy D. Moore

Columbus Oncology and Hematology Associates Inc
Columbus, OH United States
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Timothy D. Moore

Riverside Methodist Hospital
Columbus, OH United States
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Timothy D. Moore

Grant Medical Center
Columbus, OH United States
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Timothy D. Moore

The Mark H Zangmeister Center
Columbus, OH United States
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Timothy D. Moore

Mount Carmel Health Center West
Columbus, OH United States
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Timothy D. Moore

Doctors Hospital
Columbus, OH United States
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Timothy D. Moore

Delaware Health Center-Grady Cancer Center
Delaware, OH United States
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Timothy D. Moore

Delaware Radiation Oncology
Delaware, OH United States
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Timothy D. Moore

Grady Memorial Hospital
Delaware, OH United States
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Timothy D. Moore

Fairfield Medical Center
Lancaster, OH United States
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Timothy D. Moore

OhioHealth Mansfield Hospital
Mansfield, OH United States
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Timothy D. Moore

Marietta Memorial Hospital
Marietta, OH United States
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Timothy D. Moore

Knox Community Hospital
Mount Vernon, OH United States
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Timothy D. Moore

Licking Memorial Hospital
Newark, OH United States
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Timothy D. Moore

Newark Radiation Oncology
Newark, OH United States
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Timothy D. Moore

Southern Ohio Medical Center
Portsmouth, OH United States
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Timothy D. Moore

Saint Ann's Hospital
Westerville, OH United States
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Timothy D. Moore

Genesis Healthcare System Cancer Care Center
Zanesville, OH United States
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Katherine M. Moxley

University of Oklahoma Health Sciences Center
Oklahoma City, OK United States
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Katherine M. Moxley

Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, OK United States
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Radhika P. Gogoi

Geisinger Medical Center
Danville, PA United States
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Radhika P. Gogoi

Geisinger Medical Center-Cancer Center Hazleton
Hazleton, PA United States
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Radhika P. Gogoi

Geisinger Medical Oncology-Lewisburg
Lewisburg, PA United States
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Radhika P. Gogoi

Lewistown Hospital
Lewistown, PA United States
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Temple University Hospital
Philadelphia, PA United States
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Radhika P. Gogoi

Geisinger Medical Oncology-Pottsville
Pottsville, PA United States
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Radhika P. Gogoi

Community Medical Center
Scranton, PA United States
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Geisinger Medical Oncology-Selinsgrove
Selinsgrove, PA United States
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Radhika P. Gogoi

Geisinger Medical Group
State College, PA United States
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Radhika P. Gogoi

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, PA United States
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Katina M. Robison

Women and Infants Hospital
Providence, RI United States
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AnMed Health Cancer Center
Anderson, SC United States
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Saint Francis Hospital
Greenville, SC United States
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Spartanburg Medical Center
Spartanburg, SC United States
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Avera Cancer Institute
Sioux Falls, SD United States
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University of Texas Medical Branch
Galveston, TX United States
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Joseph A. Lucci

Memorial Hermann Texas Medical Center
Houston, TX United States
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UTMB Cancer Center at Victory Lakes
League City, TX United States
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Big Horn Basin Cancer Center
Cody, WY United States
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Benjamin T. Marchello

Billings Clinic-Cody
Cody, WY United States
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Welch Cancer Center
Sheridan, WY United States
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Hitoshi Niikura

Tohoku University School of Medicine
Sendai, Japan
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Takashi Sawasaki

Kure National Hospital
Kure, Japan
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Hidemichi Watari

Hokkaido University Hospital
Sapporo, Japan
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Shoji Nagao

Hyogo Cancer Center
Akashi-city, Japan
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Satoshi Takeuchi

Iwate Medical University School of Medicine
Morioka, Japan
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Toshiaki Nakamura

Kagoshima City Hospital
Kagoshima City, Japan
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Takayuki Enomoto

Niigata University Medical and Dental Hospital
Niigata City, Japan
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Yoichi Aoki

University of the Ryukyus Hospital-Col Health Scnc
Nakagami-gun, Japan
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Daisuke Aoki

Keio University
Shinjuku-ku, Japan
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Yoshiki Kudo

Hiroshima University Hospital
Hiroshima City, Japan
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Kazuhiro Takehara

Shikoku Cancer Center
Matsuyama, Japan
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National Kyushu Cancer Center
Minami-ku, Japan
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Jikei University School of Medicine
Minato-ku, Tokyo, Japan
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Kindai University
Osaka, Osaka, Japan
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Keiichi Fujiwara

Saitama Medical University International Medical Center
Saitama, Japan
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National Cancer Center Hospital
Tokyo, Japan
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Tottori University
Tottori, Japan
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National Cancer Center-Korea
Goyang-si, Korea, Republic of
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Sooyoung Hur

Catholic University of Korea-Seoul Saint Mary's Hospital
Seoul, Korea, Republic of
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Kwang-Beom Lee

Gachon University Gil Hospital
Incheon, Korea, Republic of
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Jae W. Kim

Seoul National University Hospital
Seoul, Korea, Republic of
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Sang-Wun Kim

Yonsei University Health System-Severance Hospital
Seoul, Korea, Republic of
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Jong-Min Lee

Kyung Hee University Hospital at Gangdong
Seoul, Korea, Republic of
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Jae-Hoon Kim

Gangnam Severance Hospital
Seoul, Korea, Republic of
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Joo-Hyun Nam

Asan Medical Center
Seoul, Korea, Republic of
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Shawnee Mission Medical Center-KCCC
Shawnee Mission, KS United States
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Lakeland Hospital Niles
Niles, MI United States
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Lakeland Medical Center Saint Joseph
Saint Joseph, MI United States
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Jay W. Carlson

Mercy Clinic-Rolla-Cancer and Hematology
Rolla, MO United States
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Montefiore Medical Center-Einstein Campus
Bronx, NY United States
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John W. Byron

FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, NC United States
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Timothy D. Moore

OhioHealth Marion General Hospital
Marion, OH United States
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Chi-Heum Cho

Keimyung University-Dongsan Medical Center
Ku-ch'on, Korea, Republic of
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Recruitment Status: Open


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