LUNGMAP: A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-Map Screening Study)
LUNGMAP: A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-Map Screening Study)
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
Primary Objective of the Master Protocol (LUNGMAP)
The primary objective of this screening study is to test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol.
Secondary Objectives
Screening Success Rate Objective
To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study. Screen success rates will be evaluated for the total screened population and by the subset of patients screened following progression on previous therapy or pre-screened on current therapy.
Translational Medicine Objectives
Ancillary Study S1400GEN Objectives
The Lung-MAP Screening Study includes an ancillary study evaluating patient and physician attitudes regarding the return of somatic mutation findings suggestive of a germline mutation. Participation in this study is optional.
Primary Objective
To evaluate patient attitudes and preferences about return of somatic mutation findings suggestive of a germline mutation in the Lung-MAP Screening Study.
Secondary Objectives
5.1 Registration
Step 0:
Patients who need the fresh biopsy must also submit whole blood for ctDNA testing (see Section 15.3). These patients must be registered to Step 0 to obtain a patient ID number for the submission.
Patients registered to Step 0 are not registered to the LUNGMAP protocol. To participate in LUNGMAP, patients must be registered to Step 1 after evaluation of patient eligibility, including tumor tissue adequacy, per protocol Section 5.1, Step 1.
Patients registered at Step 0 must use the same SWOG patient ID for registration at Step 1.
Step 1:
Patients must have pathologically proven non-small cell lung cancer (all histologic types) confirmed by tumor biopsy and/or fine-needle aspiration. Disease must be Stage IV as defined in Section 4.0, or recurrent. The primary diagnosis of non-small cell lung cancer should be established using the current WHO/IASLC-classification of Thoracic Malignancies. All histologies, including mixed, are allowed.
Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment.
These criteria are:
Screening at progression on prior treatment:
To be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (Stages I-IV) and must have progressed during or following their most recent line of therapy.
Pre-Screening prior to progression on current treatment:
To be eligible for pre-screening, current treatment must be for Stage IV or recurrent disease and patient must have received at least one dose of the current regimen. Patients must have previously received or currently be receiving a platinum-based chemotherapy regimen or anti-PD-1/PD-L1 therapy, alone or in combination (e.g. Nivolumab or Pembrolizumab). Patients on first-line treatment are eligible upon receiving Cycle 1, Day 1 infusion. Note: Patients will not receive their sub-study assignment until they progress and the LUNGMAP Notice of Progression is submitted.
Patients must have adequate tumor tissue available, defined as ≥ 20% tumor cells and ≥ 0.2 mm3 tumor volume.
Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform CLIA biomarker profiling, PD-L1, and c-MET IHC (see Section 15.2). If archival tumor material is exhausted, then a new fresh tumor biopsy that is formalin-fixed and paraffin-embedded (FFPE) must be obtained. Patients who need the fresh biopsy must also submit whole peripheral blood for ctDNA testing. A tumor block or FFPE slides 4-5 microns thick must be submitted. Bone biopsies are not allowed. If FFPE slides are to be submitted, at least 12 unstained slides plus an H&E stained slide, or 13 unstained slides must be submitted. However, it is strongly recommended that 20 FFPE slides be submitted. Note: Previous next-generation DNA sequencing (NGS) will be repeated if done outside this study for sub-study assignment.
Patients must agree to have any tissue that remains after testing retained for the use of sub-study Translational Medicine (TM) studies at the time of consent the patient is enrolled in.
Patients with known EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, or BRAF V600E mutation are not eligible unless they have progressed following all standard of care targeted therapy. EGFR/ALK/ROS/BRAF testing is not required prior to Step 1 registration, as it is included in the Foundation One testing for screening/pre-screening.
Patients must have Zubrod performance status 0-1 (see Section 10.2) documented within 28 days prior to Step 1 registration.
Patients must be ≥ 18 years of age.
Patients must also be offered participation in banking for future use of specimens as described in Section 15.0.
Patients must be willing to provide prior smoking history as required on the LUNGMAP Onstudy Form.
As a part of the OPEN registration process (see Section 13.4 for OPEN access instructions) the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
U.S. patients who can complete the survey and the interview by telephone or email in English must be offered participation in the S1400GEN Survey Ancillary Study if local institution's policies allow participants to receive the Amazon gift card (see Sections 15.7 and 18.5). Patients at institutions that cannot offer the survey must still participate in the main study.
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Research@carle.com800-446-5532
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CancerResearch@powershealth.org219-836-6879
219-924-8178
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225-765-7659
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Charmaine.A.Mckie@kp.org240-632-4285
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tpearce1@hfhs.org313-916-1784
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wstrong@ghci.org810-762-8038
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CVResearch@mymichigan.org989-631-2469
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574-647-7370
574-647-7370
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MCRCwebsitecontactform@stjoeshealth.org734-712-7251
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kforman1@hfhs.org313-343-3166
CVResearch@mymichigan.org989-631-2469
CVResearch@mymichigan.org989-631-2469
kfife3@hfhs.org248-849-5332
CTOResearch@hfhs.org313-916-3721
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
Emily.Crofts@trinity-health.org248-858-6215
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
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MCRCwebsitecontactform@stjoeshealth.org734-712-7251
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kforman1@hfhs.org313-343-3166
kforman1@hfhs.org313-343-3166
CTOResearch@hfhs.org313-916-3721
nhay@hfhs.org
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
CancerTrials@EssentiaHealth.org218-786-3308
218-828-2880
OncologyClinicalTrialsFargo@sanfordhealth.org218-333-5000
CancerTrials@EssentiaHealth.org218-786-3308
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
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218-692-1010
CancerTrials@EssentiaHealth.org218-786-3308
CancerTrials@EssentiaHealth.org218-786-3308
CancerTrials@EssentiaHealth.org218-786-3308
CancerTrials@EssentiaHealth.org218-786-3308
CancerTrials@EssentiaHealth.org218-786-3308
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mmcorc@healthpartners.com952-993-1517
218-365-7900
CancerTrials@EssentiaHealth.org218-786-3308
218-786-3308
218-283-9431
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1572
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mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
612-467-2800
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mmcorc@healthpartners.com952-993-1517
218-485-4481
mmcorc@healthpartners.com952-993-1517
CancerTrials@EssentiaHealth.org218-786-3308
218-568-4416
218-587-4416
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
855-776-0015
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
CancerTrials@EssentiaHealth.org218-786-3308
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218-894-7870
mmcorc@healthpartners.com952-993-1517
605-312-3320
CancerTrials@EssentiaHealth.org218-786-3308
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mmcorc@healthpartners.com952-993-1517
605-312-3320
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601-815-6700
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clinicaltrials@lakeregional.com573-302-2768
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314-996-5569
888-446-3729
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research@billingsclinic.org800-996-2663
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research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org
research@sncrf.org
research@sncrf.org702-384-0013
research@sncrf.org
research@sncrf.org
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org
research@sncrf.org702-384-0013
research@sncrf.org
research@sncrf.org
research@sncrf.org
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
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research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
603-224-2556
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800-339-6484
603-629-1828
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212-639-7592
212-639-7592
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OncologyClinicalTrialsFargo@sanfordhealth.org701-323-5760
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701-234-6161
605-312-3320
800-437-4010
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CancerTrials@EssentiaHealth.org218-786-3308
330-363-1250
Jennifer.Sexton@ohiohealth.com614-788-3860
clinical.trials@daytonncorp.org937-528-2900
Jeffh@columbusccop.org614-488-2745
clinical.trials@daytonncorp.org937-528-2900
888-293-4673
ClinicalReserachDept@aultman.com330-363-7274
clinical.trials@daytonncorp.org937-528-2900
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clinical.trials@daytonncorp.org937-528-2900
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ResearchInstituteInquiries@CommonSpirit.org720-874-1881
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
holly.henry@va.gov
ababal@metrohealth.org216-778-7559
TaussigResearch@ccf.org866-223-8100
TaussigResearch@ccf.org866-223-8100
Jamesline@osumc.edu800-293-5066
Jeffh@columbusccop.org614-488-2745
Jennifer.Sexton@ohiohealth.com614-788-3860
Jennifer.Sexton@ohiohealth.com614-788-3860
Jennifer.Sexton@ohiohealth.com614-788-3860
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jennifer.Sexton@ohiohealth.com614-788-3860
clinical.trials@daytonncorp.org937-528-2900
937-276-8320
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
Jennifer.Sexton@ohiohealth.com614-788-3860
Jennifer.Sexton@ohiohealth.com614-788-3860
Jennifer.Sexton@ohiohealth.com614-788-3860
Jennifer.Sexton@ohiohealth.com614-788-3860
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
Jeffh@columbusccop.org614-488-2745
937-569-7515
clinical.trials@daytonncorp.org937-528-2900
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jennifer.Sexton@ohiohealth.com614-788-3860
Jeffh@columbusccop.org614-488-2745
Jennifer.Sexton@ohiohealth.com614-788-3860
Jeffh@columbusccop.org614-488-2745
TaussigResearch@ccf.org866-223-8100
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jennifer.Sexton@ohiohealth.com614-788-3860
Jeffh@columbusccop.org614-488-2745
TaussigResearch@ccf.org866-223-8100
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
888-874-7000
PCIOncResearch@promedica.org419-824-1842
PCIOncResearch@promedica.org419-824-1842
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
TaussigResearch@ccf.org866-223-8100
Jeffh@columbusccop.org614-488-2745
Jennifer.Sexton@ohiohealth.com610-788-3860
Jeffh@columbusccop.org614-488-2745
clinical.trials@daytonncorp.org937-528-2900
Jeffh@columbusccop.org614-488-2745
877-231-4440
ou-clinical-trials@ouhsc.edu405-271-8777
ctsucontact@westat.com888-823-5923
405-752-3402
mccinfo@mtcancer.org406-969-6060
nosall@stcharleshealthcare.org541-706-2909
CanRsrchStudies@providence.org503-215-2614
cherie.cox@bayareahospital.org541-269-8392
canrsrchstudies@provdience.org503-215-1979
CanRsrchStudies@providence.org503-215-2614
mccinfo@mtcancer.org406-969-6060
CanRsrchStudies@providence.org503-215-2614
CanRsrchStudies@providence.org503-215-2614
CanRsrchStudies@providence.org503-215-2614
trials@ohsu.edu503-494-1080
541-706-2909
503-561-2618
Morgan_M.Horton@lvhn.org610-402-9543
protocols@swog.org
haneydl@upmc.edu412-389-5208
Morgan_M.Horton@lvhn.org610-402-9543
turzoe@mlhs.org484-476-2649
haneydl@upmc.edu412-389-5208
protocols@swog.org
lbarone@christianacare.org302-623-4450
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HemonCCTrials@geisinger.edu570-271-5251
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ClinicalResearchServices@upmc.edu412-864-7716
protocols@swog.org
877-441-7957
724-838-1900
717-632-1559
protocols@swog.org
klitchfield@PINNACLEHEALTH.org717-724-6765
Morgan_M.Horton@lvhn.org610-402-9543
haneydl@upmc.edu412-389-5208
814-534-4724
doxenberg@wellspan.org717-741-8303
HemonCCTrials@geisinger.edu570-374-8555
412-647-8073
haneydl@upmc.edu412-389-5208
turzoe@mlhs.org484-476-2649
protocols@swog.org
ClinicalResearchServices@upmc.edu412-864-7716
haneydl@upmc.edu412-389-5208
haneydl@upmc.edu412-389-5208
724-230-3030
haneydl@upmc.edu412-389-5208
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215-728-2983
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800-533-8762
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rhonda.ballew@anmedhealth.org864-512-4651
underberga@sjchs.org912-819-5704
Kim.Williams3@prismahealth.org864-522-4317
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hcc-clinical-trials@musc.edu843-792-9321
Kim.Williams3@prismahealth.org864-522-4317
Kim.Williams3@prismahealth.org864-522-4317
Kim.Williams3@prismahealth.org864-522-4317
Kim.Williams3@prismahealth.org864-522-4317
Kim.Williams3@prismahealth.org864-522-4317
Kim.Williams3@prismahealth.org864-522-4317
Kim.Williams3@prismahealth.org864-522-4317
underberga@sjchs.org912-819-5704
Kim.Williams3@prismahealth.org864-522-4317
research@monument.health605-755-2370
OncologyClinicTrialsSF@sanfordhealth.org605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org605-312-3320
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866-687-8387
Charmaine.A.Mckie@kp.org240-632-4285
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Kevin.Patel@centrahealth.com434-200-1495
Charmaine.A.Mckie@kp.org240-632-4285
anne_carmellat@bshsi.org804-893-8978
anne_carmellat@bshsi.org804-893-8978
anne_carmellat@bshsi.org804-893-8978
anne_carmellat@bshsi.org804-893-8978
anne_carmellat@bshsi.org804-893-8978
smoore@vacancer.com804-287-3000
Anne_caramella@bshsi.org804-893-8978
ctoclinops@vcu.edu
Regina.McClung@va.gov804-675-5646
CTOclinops@vcu.edu804-628-6430
nemer.elmouallem@vcuhealth.org
William.Houck@usoncology.com540-662-1108
Charmaine.A.Mckie@kp.org240-632-4285
deidre.dillon@providence.org360-412-8958
425-454-2148
achapman1@peacehealth.org360-788-8223
deidre.dillon@providence.org360-412-8958
PCRC-NCORP@Swedish.org206-215-2343
marilyn.birchman@providence.org425-261-3529
PCRC-NCORP@Swedish.org206-215-2343
research@kadlecmed.org509-783-4637
425-899-6000
deidre.dillon@providence.org360-412-8958
kmakin-bond@peacehealth.org360-514-2016
rcccclinicalresearch@skagitvalleyhospital.org360-814-2182
research@valleymed.org425-228-3440
PCRC-NCORP@Swedish.org206-215-3086
800-804-8824
PCRC-NCORP@Swedish.org206-215-3086
PCRC-NCORP@Swedish.org206-215-2343
206-606-5800
800-804-8824
achapman1@peacehealth.org360-788-8239
research@ccnw.net509-228-1680
research@ccnw.net509-228-1680
research@ccnw.net509-228-1680
kmakin-bond@peacehealth.org360-514-3940
Cheryl.Dodd@providence.org509-897-5993
Memorial-ClinicalTrials@yvmh.org509-574-3535
cancertrialsinfo@hsc.wvu.edu304-293-7374
304-388-9944
Christina.Cole@chhi.org304-399-6566
304-526-1349
cancertrialsinfo@hsc.wvu.edu304-293-7374
cancertrialsinfo@hsc.wvu.edu304-293-7374
cancertrialsinfo@hsc.wvu.edu304-293-7374
304-243-6442
Juli.Alford@aspirus.org715-623-9869
AWRI.inquiry@ascension.org
CancerTrials@EssentiaHealth.org218-786-3308
CancerTrials@EssentiaHealth.org218-786-3308
AWRI.Inquiry@Ascension.org
ncorp@aurora.org414-302-2304
AWRI.inquiry@ascension.org
oncology.clinical.trials@marshfieldresearch.org800-782-8581
ncorp@aurora.org414-302-2304
oncology.clinical.trials@marshfieldresearch.org800-782-8581
ncorp@aurora.org414-302-2304
AWRI.Inquiry@Ascension.org
AWRI.Inquiry@Ascension.org
ncorp@aurora.org414-302-2304
ncorp@aurora.org414-302-2304
WI_research_admin@hshs.org920-433-8889
wi_research_admin@hshs.org920-433-8889
ncorp@aurora.org414-302-2304
CancerTrials@EssentiaHealth.org218-786-3308
218-568-4416
oncologyclinicaltrials@mhemail.org608-756-6871
ncorp@aurora.org414-302-2304
cancerctr@gundersenhealth.org608-775-2385
oncology.clinical.trials@marshfieldresearch.org800-782-8581
clinicaltrials@cancer.wisc.edu800-622-8922
clinicaltrials@cancer.wisc.edu800-622-8922
ncorp@aurora.org414-302-2304
oncology.clinical.trials@marshfieldresearch.org800-782-8581
Beth.Knetter@aspirus.org715-847-2353
262-257-5100
AWRI.Inquiry@Ascension.org
ncorp@aurora.org414-302-2304
AWRI.Inquiry@Ascension.org
AWRI.Inquiry@Ascension.org
AWRI.Inquiry@Ascension.org
ncorp@aurora.org414-302-2304
414-805-3666
ncorp@aurora.org414-302-2304
888-469-6614
oncology.clinical.trials@marshfieldresearch.org800-782-8581
research.institute@phci.org
mmcorc@healthpartners.com952-993-1517
262-928-7878
WI_research_admin@hshs.org920-433-8889
AWRI.inquiry@ascension.org
ncorp@aurora.org414-302-2304
AWRI.Inquiry@Ascension.org
ncorp@aurora.org414-302-2304
Beth.Knetter@aspirus.org715-847-2353
oncology.clinical.trials@marshfieldresearch.org800-782-8581
wi_research_admin@hshs.org920-433-8889
wi_research_admin@hshs.org920-433-8889
ncorp@aurora.org414-302-2304
CancerTrials@EssentiaHealth.org218-786-3308
Beth.Knetter@aspirus.org715-847-2353
oncology.clinical.trials@marshfieldresearch.org800-782-8581
wi_research_admin@hshs.org920-433-8889
701-364-6272
ncorp@aurora.org414-302-2304
262-928-7632
Chanda.miller@phci.org262-928-5539
877-405-6866
oncology.clinical.trials@marshfieldresearch.org800-782-8581
AWRI.Inquiry@Ascension.org
ncorp@aurora.org414-302-2304
ncorp@aurora.org414-302-2304
414-805-0505
oncology.clinical.trials@marshfieldresearch.org800-782-8581
715-422-7718
oncology.clinical.trials@marshfieldresearch.org800-782-8581
protocols@swog.org
research@billingsclinic.org800-996-2663