Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study
Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study
This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments.
PRIMARY OBJECTIVE:
I. To both develop and independently validate a risk prediction model for Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher non-hematological immune-related adverse events (irAEs) in the first year of immune checkpoint inhibitor (ICI)-based therapy for the treatment of solid tumors.
SECONDARY OBJECTIVES:
I. To prospectively assess the incidence of any grade of non-hematological irAEs and grade 4 hematological irAEs on ICI-based therapy.
II. To observe the trajectory of patient-reported quality of life and health preferences over 12 months.
III. To observe the trajectory of patient-reported adverse events over 12 months using serial assessment with select Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures.
IV. To measure the burden of chronic, grade 1 and 2 toxicities using methods such as toxicity over time (ToxT).
V. To track patterns of treatment of irAEs and patterns of toxicity resolution.
TRANSLATIONAL MEDICINE OBJECTIVES:
I. To evaluate the cytokine toxicity (CYTOX) score, a composite measure derived from 11 different cytokine levels, both prior to ICI-based therapy and after 1 cycle of ICI-based therapy as a predictive signature for the development of irAEs.
II. To establish a repository of archival tissue and blood/serum specimens for potential predictive and/or prognostic markers of irAE risk.
ADDITIONAL OBJECTIVE:
I. To assess the feasibility of using electronic (e)PRO in a multi-center clinical trial setting.
OUTLINE:
Patients undergo collection of a tissue sample at the start of their routine cancer treatment. Patients complete questionnaires at the start of cancer treatment, weeks 4, 12, 24, and 52. Patients will have the option of providing blood samples at several time points during the study.
Inclusion Criteria:
Participants must be planning to receive ICI-based therapy for a solid tumor malignancy. This therapy must be given according to Food and Drug Administration (FDA) label or National Comprehensive Cancer Network (NCCN) guidelines at Category 1 or 2A and not in the context of a clinical trial
Participants who have received prior ICI-based therapy must have completed ICI based therapy at least 180 days prior to registration
Participants must not have discontinued any prior ICI-based therapy (if applicable) because of irAE
Participants must not have received chemotherapy, biologic, or targeted-therapy within 21 days prior to registration
Participants must have recovered from side effects of prior therapy to the following standards per treating physician's discretion:
Participants must be planning to begin standard of care ICI-based therapy within 3 calendar days after registration
Participants must not be planning to receive ICI-based therapy in combination with chemotherapy or any other non-ICI therapy for treatment of their cancer
Participants must be at least 18 years of age
Participants must complete their history and physical examination within 28 days prior to registration
Participants who can complete the S2013 Feasibility Questionnaire in English or Spanish must participate at the scheduled assessments
Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English, Spanish, or French and must be planning to complete PROs at all scheduled assessments
Participants must complete the pre-registration (baseline) PRO forms within 14 days prior to registration
Participants must be willing to participate in PRO data collection
Participants must be offered the opportunity to participate in the optional specimen banking
Note: As a part of the OPEN registration process 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.
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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
973-971-5990
973-971-5900
973-971-5990
973-971-5990
908-522-2043
cancerclinicaltrials@cumc.columbia.edu
877-697-9355
Stephanie.Solito@chsli.org516-325-7514
cancerclinicaltrials@cumc.columbia.edu212-342-5162
kl2965@cumc.columbia.edu718-584-9000
516-326-7514
stacey.phelps@conehealth.com336-832-0836
AMBER.WHEELER@AdventHealth.com828-650-8037
stacey.phelps@conehealth.com336-832-0836
jfields@cancersmoc.com919-587-9084
AMBER.WHEELER@AdventHealth.com828-650-8037
tammy.cozad@caromonthealth.org704-834-2810
jfields@cancersmoc.com919-587-9084
stacey.phelps@conehealth.com336-832-0836
stacey.phelps@conehealth.com336-832-0836
pardeecancerresearch@unchealth.unc.edu828-696-4716
AMBER.WHEELER@AdventHealth.com828-650-8037
jfields@cancersmoc.com910-587-9084
jcwilliams@firsthealth.org910-715-3500
stacey.phelps@conehealth.com336-832-0836
AMBER.WHEELER@AdventHealth.com828-650-8037
OncologyClinicalTrialsFargo@sanfordhealth.org701-323-5760
701-234-6161
605-312-3320
800-437-4010
OncologyClinicalTrialsFargo@sanfordhealth.org701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org701-234-6161
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org877-779-7585
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
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
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
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
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
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
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@providence.org503-215-2614
mccinfo@mtcancer.org406-969-6060
CanRsrchStudies@providence.org503-215-2614
CanRsrchStudies@providence.org503-215-2614
CanRsrchStudies@providence.org503-215-2614
information@kpchr.org503-335-2400
541-706-2909
Morgan_M.Horton@lvhn.org610-402-9543
Morgan_M.Horton@lvhn.org610-402-9543
lbarone@christianacare.org302-623-4450
HemonCCTrials@geisinger.edu570-271-5251
Morgan_M.Horton@lvhn.org610-402-9543
HemonCCTrials@geisinger.edu570-459-2901
Morgan_M.Horton@lvhn.org610-402-9543
HemonCCTrials@geisinger.edu570-374-8555
HemonCCTrials@geisinger.edu800-275-6401
HemonCCTrials@geisinger.edu570-703-4768
HemonCCTrials@geisinger.edu570-374-8555
HemonCCTrials@geisinger.edu570-271-5251
underberga@sjchs.org912-819-5704
Kim.Williams3@prismahealth.org864-522-4317
ashley.salvo@va.gov843-789-7020
Kim.Williams3@prismahealth.org864-522-4317
dorie.sturgill@mcleodhealth.org843-777-0770
kmertz-rivera@gibbscc.org864-560-6104
Kim.Williams3@prismahealth.org864-522-4317
Kim.Williams3@prismahealth.org864-522-4317
Kim.Williams3@prismahealth.org864-522-4317
Kim.Williams3@prismahealth.org864-522-4317
kmertz-rivera@gibbscc.org864-560-6104
underberga@sjchs.org912-819-5704
Kim.Williams3@prismahealth.org864-522-4317
864-560-6812
kmertz-rivera@gibbscc.org864-560-6104
864-560-6812
kmertz-rivera@gibbscc.org864-560-6104
OncologyClinicTrialsSF@sanfordhealth.org605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org605-312-3320
charles.mays@balladhealth.org423-431-5654
BCCclintrials@bmhcc.org901-226-1366
charles.mays@balladhealth.org423-431-5654
charles.mays@balladhealth.org423-431-5654
charles.mays@balladhealth.org423-431-5654
BCCclintrials@bmhcc.org901-226-1366
charles.mays@balladhealth.org423-431-5654
sharon.hubbard@lpnt.net276-666-7489
charles.mays@balladhealth.org423-431-5654
deidre.dillon@providence.org360-412-8958
KPWAoncologytrials@kp.org206-287-2049
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
deidre.dillon@providence.org360-412-8958
kmakin-bond@peacehealth.org360-514-2016
rcccclinicalresearch@skagitvalleyhospital.org360-814-2182
360-344-3091
research@valleymed.org425-228-3440
PCRC-NCORP@Swedish.org206-215-3086
KPWAoncologytrials@kp.org206-287-2049
PCRC-NCORP@Swedish.org206-215-3086
PCRC-NCORP@Swedish.org206-215-2343
achapman1@peacehealth.org360-788-8239
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
kmakin-bond@peacehealth.org360-514-3940
Cheryl.Dodd@providence.org509-897-5993
Memorial-ClinicalTrials@yvmh.org509-574-3535
Juli.Alford@aspirus.org715-623-9869
ResearchDept@thedacare.org920-364-3604
AWRI.inquiry@ascension.org
ResearchDept@thedacare.org920-364-3605
AWRI.Inquiry@Ascension.org
ncorp@aurora.org414-302-2304
AWRI.inquiry@ascension.org
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
ncorp@aurora.org414-302-2304
cancerctr@gundersenhealth.org608-775-2385
ncorp@aurora.org414-302-2304
oncology.clinical.trials@marshfieldresearch.org800-782-8581
Beth.Knetter@aspirus.org715-847-2353
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
ncorp@aurora.org414-302-2304
oncology.clinical.trials@marshfieldresearch.org800-782-8581
ResearchDept@thedacare.org920-364-3605
ResearchDept@thedacare.org920-364-3605
mmcorc@healthpartners.com952-993-1517
WI_research_admin@hshs.org920-433-8889
AWRI.inquiry@ascension.org
ResearchDept@thedacare.org920-364-3605
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
ResearchDept@thedacare.org920-364-3605
wi_research_admin@hshs.org920-433-8889
wi_research_admin@hshs.org920-433-8889
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
ncorp@aurora.org414-302-2304
ResearchDept@thedacare.org920-364-3605
877-405-6866
AWRI.Inquiry@Ascension.org
ncorp@aurora.org414-302-2304
ncorp@aurora.org414-302-2304
oncology.clinical.trials@marshfieldresearch.org800-782-8581
715-422-7718
research@billingsclinic.org800-996-2663
671-646-5825