S1013: Validation of Cancer Questionnaire for Skin Toxicities in Patients With Colorectal Cancer or Lung Cancer Receiving Cetuximab, Panitumumab, or Erlotinib Hydrochloride



Status:Completed
Conditions:Lung Cancer, Colorectal Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:9/2/2018
Start Date:November 2011
End Date:July 2018

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S1013: A Prospective Study of Epidermal Growth Factor Receptor (HER-1/EGFR) Inhibitor-Induced Dermatologic Toxicity: Validation of the Functional Assessment of Cancer Therapy-EGFRI 18(FACT-EGFRI 18) Questionnaire for EGFRI-Induced Skin Toxicities

RATIONALE: Questionnaires that patients can use to assess skin toxicities related to
treatment may help identify the intermediate-and long-term effects of cetuximab, panitumumab,
or erlotinib hydrochloride.

PURPOSE: This trial studies the validation of a cancer questionnaire for skin toxicities in
patients with colorectal or lung cancer receiving cetuximab, panitumumab, or erlotinib
hydrochloride.

OBJECTIVES:

Primary

- To establish psychometric properties for the Functional Assessment of Cancer Therapy
Epidermal Growth Factor Receptor Inhibitor (FACT-EGFRI 18) module (based on criterion
validity, known group's validity, internal consistency reliability, and responsiveness
to change) as a patient-reported outcome (PRO) measure of EGFRI-induced skin-related
toxicity.

Secondary

- To document minimally important differences over time for the FACT-EGFRI 18 by comparing
mean changes in this PRO measure to the patient's direct assessment of change using two
anchor items (change in skin condition severity and impact).

- To examine the association between toxicity profiles (severity and time to onset), and
treatment profiles (e.g., delays and discontinuation) and the FACT-EGFRI 18 scores.

- To assess degree of concordance between FACT-EGFRI 18 ratings and study site physician
CTCAE Version 4.0 EGFRI-Induced Dermatologic Toxicity Grading Assessment ratings.

- To evaluate feasibility outcomes.

OUTLINE: This is a multicenter study.

Patients complete the S1013 Functional Assessment of Cancer Therapy Epidermal Growth Factor
Receptor Inhibitor (FACT-EGFRI 18) at baseline and prior to beginning therapy and clinical
assessment. Patients also complete FACT-EGFRI 18 and the Changes in Skin Symptoms on days 1*,
8**, 15, 22, 29, 36, 43, 71, 99, and 127. Patients who do not develop any grade of
papulopustular rash within 42 days are removed from study.

Investigators performing the patients' clinical assessment complete the EGFRI-Induced
Dermatologic Toxicity Grading Assessment on days 1, 8, 15, 22, 29, 36, 43, 71, 99, and 127,
and the Treatment Form assessment on days 22, 43, 71, 99, and 127. Nurses or clinical trial
administrators (CRA) also complete the S1013 Cover Sheet for Patient Complete Questionnaires
accompanying the FACT-EGFRI 18 patients' questionnaires at each schedule assessment.

NOTE: *Patients start EGFRI therapy.

NOTE: **Change in Skin Symptoms questionnaire starts on Day 8.

DISEASE CHARACTERISTICS:

- Patients must have a diagnosis of colorectal or lung cancer and be planning to receive
one of the following epidermal growth factor receptor (HER1/EGFR) inhibitor therapies
listed below for at least 6 weeks:

- Cetuximab 400 mg/m² loading dose, 250 mg/m² weekly

- Cetuximab 500 mg/m² every 2 weeks

- Panitumumab 6 mg/kg every 2 weeks

- Erlotinib hydrochloride 100-150 mg daily

- Other HER1/EGFR inhibitor therapies, schedules, or doses of the above listed
agents are not allowed

- Concurrent chemotherapy and other anti-cancer therapies (such as carboplatin,
paclitaxel, and bevacizumab) are allowed EXCEPT for the following
chemotherapeutic agents that are known to cause skin rash that could interfere
with EGFRI-induced skin toxicity assessment: gemcitabine, capecitabine, and
topical fluorouracil (Efudex™, Fluoroplex™, Carac™)

- Patients must have completed the baseline S1013 Functional Assessment of Cancer
Therapy- (FACT) EGFRI 18 within 7 days prior to registration

PATIENT CHARACTERISTICS:

- Patients must have a Zubrod performance status of 0-2

- Patients must not have any of the following serious concomitant skin disorders that,
in the investigator's opinion, could interfere with assessment of epidermal growth
factor receptor inhibitor (EGFRI)-induced skin toxicity: atopic dermatitis [eczema];
contact dermatitis; psoriasis; rosacea; severe photosensitivity; scleroderma;
steroid-induced acne; or xerosis

- Patients must be able to complete questionnaires in English

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Patients may have had prior epidermal growth factor receptor (HER1/EGFR) inhibitor
therapy but must have fully recovered from any skin toxicities prior to registration

- Patients must not be planning to receive any of the following concomitant medications
that can cause skin rash or other dermatologic reactions that could interfere with the
EGFRI-induced skin toxicity assessments, for the duration of the study: allopurinol;
systemic corticosteroids; topical retinoids (Retin-A™, Tretinoin™); or oral retinoids
(Amnesteem™, Claravis™, Sotret™)

- Patients must not be planning to receive concurrent external-beam radiation therapy,
including prophylactic cranial radiation

- Patients may concurrently participate in other therapeutic clinical trials
We found this trial at
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2700 Wayne Memorial Dr
Goldsboro, North Carolina 27534
(919) 736-1110
Principal Investigator: James N. Atkins
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
Principal Investigator: Marianna Koczywas
Phone: 800-826-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Asheville, North Carolina 28801
Principal Investigator: Christopher H. Chay
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Asheville, North Carolina 28801
Principal Investigator: Christopher H. Chay
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Asheville, North Carolina 28816
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Bloomington, Illinois 61701
Principal Investigator: James L. Wade
Phone: 217-876-4740
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Principal Investigator: James L. Wade
Phone: 217-876-4740
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Bonne Terre, Missouri 63628
Principal Investigator: James L. Wade
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
Principal Investigator: James L. Wade
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Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
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Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
Principal Investigator: James L. Wade
Phone: 217-876-4740
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Carbondale, Illinois 62902
Principal Investigator: James L. Wade
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
Principal Investigator: James L. Wade
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Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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20126 Stanton Ave
Castro Valley, California 94546
(510) 581-0556
East Bay Radiation Oncology Center East Bay Radiation Oncology Center offers superior medical and technical...
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Centralia, Illinois 62801
Principal Investigator: James L. Wade
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Principal Investigator: Shaker R. Dakhil
Phone: 316-262-4467
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Charlotte, North Carolina 28204
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Clinton, North Carolina 28328
Principal Investigator: James N. Atkins
Phone: 919-580-0000
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Concord, North Carolina 28025
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Decatur, Illinois 62526
Principal Investigator: James L. Wade
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Principal Investigator: James L. Wade
Phone: 217-876-4740
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Decatur, Illinois 62526
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2020 Central Ave
Dodge City, Kansas 67801
(620) 227-2488
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Dublin, California 94568
Principal Investigator: James H. Feusner
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Effingham, Illinois 62401
Principal Investigator: James L. Wade
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700 West Central
El Dorado, Kansas 67042
(316) 889-0099
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Emeryville, California 94608
Principal Investigator: James H. Feusner
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Emeryville, California 94608
Principal Investigator: James H. Feusner
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101 S Major St
Eureka, Illinois 61530
309-467-2371
Principal Investigator: James L. Wade
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Evergreen Park, Illinois 60805
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Flint, Michigan 48532
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Flint, Michigan 48532
Principal Investigator: Justin F. Klamerus
Phone: 810-342-4071
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Fort Scott, Kansas 66701
(620) 223-8589
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Galesburg, Illinois 61401
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3315 N Seminary St
Galesburg, Illinois 61401
309-344-9269
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Goldsboro, North Carolina 27534
Principal Investigator: James N. Atkins
Phone: 919-580-0000
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Hendersonville, North Carolina 28971
Principal Investigator: James E. Radford
Phone: 828-696-4716
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Hendersonville, North Carolina 28791
Principal Investigator: James E. Radford
Phone: 828-696-4716
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High Point, North Carolina 27261
Principal Investigator: Jason D. Huff
Phone: 336-832-0821
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800 W. Laurel
Independence, Kansas 67301
620-331-4099
Principal Investigator: Shaker R. Dakhil
Phone: 316-262-4467
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Independence, Missouri 64057
Principal Investigator: Rakesh Gaur
Phone: 913-948-5588
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Jacksonville, North Carolina 28546
Principal Investigator: James N. Atkins
Phone: 919-580-0000
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1432 Southwest Blvd.
Jefferson City, Missouri 65109
(573) 632-4800
Principal Investigator: James L. Wade
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Capital Region Medical Center-Goldschmidt Cancer Center At the Goldschmidt Cancer Center in Jefferson City, board...
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Principal Investigator: Rakesh Gaur
Phone: 913-948-5588
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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5400 N Oak Trafficway, Suite 101
Kansas City, Missouri 64118
(855) 603-3282
Principal Investigator: Rakesh Gaur
Phone: 913-948-5588
Heartland Hematology Oncology Associates, Incorporated Heartland Hematology-Oncology Associates PA in Kansas, Missouri, is a private...
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
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Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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205 Tenney St
Kewanee, Illinois 61443
309-852-0596
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Illinois CancerCare - Kewanee Clinic Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer...
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750 Avenue D West
Kingman, Kansas 67068
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3855 Health Sciences Dr,
La Jolla, California 92093
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325 Maine Street
Lawrence, Kansas 66044
(785) 505-5000
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Phone: 316-262-4467
Lawrence Memorial Hospital Lawrence Memorial Hospital (LMH), in collaboration with its medical staff, is dedicated...
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100 NE St Lukes Blvd
Lee's Summit, Missouri 64086
(816) 347-5000
Principal Investigator: Rakesh Gaur
Phone: 913-948-5588
Saint Luke's East - Lee's Summit Founded in 2006, Saint Luke
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315 W. 15th St.
Liberal, Kansas 67905
(620) 629-6727
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Cancer Center of Kansas, PA - Liberal Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Liberty, Missouri 64068
Principal Investigator: Rakesh Gaur
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
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1983 Marengo St
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
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U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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501 E Grant
Macomb, Illinois 61455
309-833-3503
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Illinois CancerCare - Macomb Illinois CancerCare is one of the largest private oncology and hematology...
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Manhattan, Kansas 66502
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2500 Alhambra Ave
Martinez, California 94553
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1000 Hospital Dr.
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259 1st St
Mineola, New York 11501
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Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Monroe, Louisiana 71202
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720 Medical Center Drive
Newton, Kansas 67114
(316) 282-0888
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Oakland, California 94609
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1411 E 31st St
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350 Hawthorne Ave
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Oakland, California 94609
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Ottawa, Illinois 61350
Principal Investigator: James L. Wade
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1200 Starfire Drive
Ottawa, Illinois 61350
815-431-9270
Principal Investigator: James L. Wade
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Illinois CancerCare-Ottawa Clinic Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases....
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5721 W 119th St
Overland Park, Kansas 66209
(913) 498-6000
Principal Investigator: Rakesh Gaur
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Menorah Medical Center Menorah Medical Center (MMC), a full-service, acute care hospital located on the...
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12300 Metcalf Ave
Overland Park, Kansas 66213
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1902 S. US Hwy 59
Parsons, Kansas 67357
(620) 421-2855
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603 S 13th St
Pekin, Illinois 61554
(309) 353-0214
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Peoria, Illinois 61637
Principal Investigator: James L. Wade
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221 NE Glen Oak Ave
Peoria, Illinois 61636
(309) 672-5522
Principal Investigator: James L. Wade
Phone: 217-876-4740
Methodist Medical Center of Illinois UnityPoint Health is one of the nation's most integrated health...
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8940 Wood Sage Rd
Peoria, Illinois 61615
(309) 243-3000
Principal Investigator: James L. Wade
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Peru, Illinois 61354
Principal Investigator: James L. Wade
Phone: 217-876-4740
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4391 Venture Dr.
Peru, Illinois 61354
815-223-7010
Principal Investigator: James L. Wade
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124 Commodore, Ste. A
Pratt, Kansas 67124
(620) 672-2478
Principal Investigator: Shaker R. Dakhil
Phone: 316-262-4467
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530 Park Ave East
Princeton, Illinois 61356
815-875-3010
Principal Investigator: James L. Wade
Phone: 217-876-4740
Illinois CancerCare - Princeton Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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3333 W Deyoung St
Saint Joseph, Missouri 64506
(618) 998-7000
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Phone: 913-948-5588
Heartland Regional Medical Center Heartland Regional Medical Center is your community healthcare provider; a 98-bed...
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3015 North Ballas Road
Saint Louis, Missouri 63131
(314) 996-5000
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Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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Sainte Genevieve, Missouri 63670
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600 S Santa Fe Ave
Salina, Kansas 67401
(785) 823-1521
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Phone: 316-262-4467
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Shelby, North Carolina 28150
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Shreveport, Louisiana 71103
Principal Investigator: Gary V. Burton
Phone: 318-813-1412
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Shreveport, LA
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Springfield, Illinois 62701
Principal Investigator: James L. Wade
Phone: 217-876-4740
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801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Principal Investigator: James L. Wade
Phone: 217-876-4740
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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Springfield, IL
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701 N 1st St
Springfield, Illinois 62781
(217) 788-3000
Principal Investigator: James L. Wade
Phone: 217-876-4740
Memorial Medical Center Memorial Medical Center is a Magnet-designated, acute care hospital in Springfield that...
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Springfield, IL
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Springfield, Illinois 62703
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Sullivan, Missouri 63080
Principal Investigator: James L. Wade
Phone: 217-876-4740
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Sullivan, MO
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Sunset Hills, Missouri 63127
Principal Investigator: James L. Wade
Phone: 217-876-4740
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Sunset Hills, MO
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