Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Observational Research Study for Cancer Patients on Immune Checkpoint Inhibitors, DiRECT Study (DiRECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05364086
Recruitment Status : Recruiting
First Posted : May 6, 2022
Last Update Posted : May 23, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Charles Kamen, University of Rochester NCORP Research Base

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study compares treatment outcomes between patients of African American/Black (AA) ancestry and European American/White (EA) ancestry currently receiving immune checkpoint inhibitor treatment. Collecting samples of blood and saliva and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand health care disparities among all cancer patients.

Condition or disease
Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Detailed Description:

PRIMARY OBJECTIVE:

I. To compare incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 2-5 immune-related adverse reactions (irAEs) between African American (AA) and European American (EA) patients within the first year of starting immune checkpoint inhibitor (ICI) treatment.

SECONDARY OBJECTIVES:

I. To compare objective response rate (ORR) to ICI treatment between AA and EA patients within the first year of starting ICI treatment.

II. To compare health-related quality of life (HRQOL) measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Preference (Patient Reported Outcomes [PRO] Pr) summary score and Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM) between AA and EA patients within 1 year of starting ICI treatment.

EXPLORATORY OBJECTIVES:

I. To compare AA and EA patients on severity (i.e., CTCAE grade) and timing of irAEs within 1 year of starting ICI treatment.

II. To assess disease, treatment, individual, and behavioral factors as predictors of grade 2-5 irAEs, and as potential causes of racial differences in irAEs, within 1 year of starting ICI treatment.

III. To compare AA and EA patients on long-term outcomes (e.g., progression-free survival [PFS], overall survival [OS], and HRQOL beyond the first year) at the end of the study period.

IV. To assess the impact of irAEs and disease, treatment, behavioral, and individual factors on ICI outcomes (ORR, HRQOL, PFS, OS), and as potential causes of racial differences in outcomes, at the end of the study period.

V. To compare ICI treatment patterns (e.g., delay and discontinuation of ICI treatment) between AA and EA patients within 1 year of starting ICI treatment.

VI. To assess irAEs, treatment, disease, and individual factors, including healthcare barriers, as possible reasons for suboptimal treatment patterns, and as potential causes of racial differences, within 1 year of starting ICI treatment.

OUTLINE:

Patients complete questionnaires and undergo collection of blood and saliva samples before 1st and 2nd infusion of immunotherapy, 6 months after 1st infusion of immunotherapy, and then every year after 1st infusion of immunotherapy. Patients also undergo collection of saliva samples before 1st and 2nd infusion of immunotherapy. A tumor sample will also be collected at the beginning of the study and patients medical records will be reviewed.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated With Anti-PD-1/Anti-PD-L1 Immunotherapy in a Community Oncology Setting
Actual Study Start Date : April 26, 2022
Estimated Primary Completion Date : May 31, 2027
Estimated Study Completion Date : May 31, 2027
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Observational (questionnaire, biospecimen, medical records))
Patients complete questionnaires and undergo collection of blood and saliva samples before 1st and 2nd infusion of immunotherapy, 6 months after 1st infusion of immunotherapy, and then every year after 1st infusion of immunotherapy. Patients also undergo collection of saliva samples before 1st and 2nd infusion of immunotherapy. A tumor sample will also be collected at the beginning of the study and patients medical records will be reviewed.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of immune-related adverse events (irAEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Within 1 year after starting immune checkpoint inhibitor (ICI) treatment ]
    Rate of grade 2-5 immune-related adverse events (irAEs) will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE). Racial differences in irAE rates will be assessed in bivariate analysis by Chi-square, Wilcoxon rank-sum test, or two sample t-tests.


Secondary Outcome Measures :
  1. Overall response rate (ORR) to immune checkpoint inhibitors (ICIs) assessed by physician report [ Time Frame: Within 1 year after starting ICI treatment ]
    Overall response rate (ORR) to immune checkpoint inhibitors (ICIs) will be rated by physicians (complete response, partial response, stable disease, unconfirmed/confirmed progression, recurrence). Multivariable modeling will be conducted to adjust for covariates to establish racial differences in ORR.

  2. Health-related quality of life (HRQOL) measured using the PROMIS-Preference (PROPr) summary score [ Time Frame: Within 1 year after starting ICI treatment ]
    The PROMIS-Preference (PROPr) score is a summary score based on scores for Cognitive Function Abilities, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities indices from the PROMIS-29 profile.

  3. Health-related quality of life (HRQOL) measured using the Functional Assessment of Cancer Treatment - Immune Checkpoint Modulation (FACT-ICM) [ Time Frame: Within 1 year after starting ICI treatment ]
    The Functional Assessment of Cancer Treatment - Immune Checkpoint Modulation (FACT-ICM) contains 25 items. Participants rate severity of ICI-related symptoms on a scale from 0, "not at all," to 4, "very much."


Other Outcome Measures:
  1. Severity and timing of immune-related adverse events (irAEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Within 1 year after starting ICI treatment ]
    Severity and timing of grade 2-5 immune-related adverse events (irAEs) will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE). Racial differences in irAE rates will be assessed in bivariate analysis by Chi-square, Wilcoxon rank-sum test, or two sample t-tests.

  2. Progression-free survival [ Time Frame: Up to 4 years ]
    Two sample t-test or Wilcoxon rank test will be conducted for continuous outcomes. Log-rank test will be used to evaluate between group (AA versus [vs.] AE) for time-dependent variables. Multivariable Cox regression will be conducted to adjust for imbalance in covariates.

  3. Health related quality of life (HRQOL) since ICI treatment at the end of the study periodHealth-related quality of life (HRQOL) measured using the PROMIS-Preference (PROPr) summary score at the end of the study period [ Time Frame: Up to 4 years ]
    Will be examined at the end of the study period (up to 4 years) using a two sample t-test to compare racial groups.

  4. Treatment delay and discontinuation [ Time Frame: Within 1 year after starting ICI treatment ]
    Treatment delay is defined as time lapse between two consecutive infusion cycles >4 weeks (yes/no), and discontinuation as permanently holding further administration of ICI immunotherapy due to toxicities or disease progression in the metastatic setting, or total infusion cycles of ICIs fewer than that recommended according to National Comprehensive Cancer Network (NCCN) guidelines as a result of premature termination due to toxicities in the adjuvant setting (yes/no).


Biospecimen Retention:   Samples With DNA
Tumor, Blood, and saliva

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
African American or European American patients diagnosed with stage I-IV invasive cancer receiving immune checkpoint inhibitor treatment
Criteria

Inclusion Criteria:

  • Be 18 years of age or older

  • Self-identify as African/African American/black (AA), or European American/ Caucasian/white (EA)

    • Patients may identify a Hispanic/Latino ethnicity in combination with an AA or EA racial identity

  • Have a current diagnosis of invasive cancer at stage I-IV

    • Patients may have a history of previous cancer diagnosis and cancer treatment not involving immunotherapy
  • Be scheduled to receive anti-PD-1/-L1 ICI-containing therapy according to Food and Drug Administration (FDA) labels or National Comprehensive Cancer Network (NCCN) guidelines at Category 1 or 2A as standard of care treatment alone or in combination with co-treatments (including alternative ICIs)
  • Be able to speak and read English or Spanish
  • Be able to provide written or remote informed consent

Exclusion Criteria:

  • Identify as Asian, Pacific Islander, or American Indian/Alaskan Native
  • Be diagnosed with melanoma (because melanoma is very rare in AAs)
  • Currently participate or plan to participate in any other cancer treatment trials
  • Have received prior immunotherapy for cancer, including checkpoint inhibitors, chimeric antigen receptor (CAR)-T therapy, and/or cytokine therapy
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05364086


Contacts
Layout table for location contacts
Contact: Linda Spath 585-275-1364 URCC_21038@urmc.rochester.edu
Contact: Kari Gilliland 585-275-6303 URCC_21038@urmc.rochester.edu

Locations
Layout table for location information
United States, Illinois
Saint Anthony's Health Recruiting
Alton, Illinois, United States, 62002
Contact: Site Public Contact    618-463-5623      
Principal Investigator: Jay W. Carlson         
SIH Cancer Institute Recruiting
Carterville, Illinois, United States, 62918
Contact: Site Public Contact    618-985-3333    clinical.research@sih.net   
Principal Investigator: Bryan A. Faller         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    217-545-7929      
Principal Investigator: Bryan A. Faller         
Springfield Clinic Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    800-444-7541      
Principal Investigator: Bryan A. Faller         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Contact: Site Public Contact    217-528-7541    pallante.beth@mhsil.com   
Principal Investigator: Bryan A. Faller         
United States, Kansas
Central Care Cancer Center - Garden City Recruiting
Garden City, Kansas, United States, 67846
Contact: Site Public Contact    913-948-5588    aroland@kccop.org   
Principal Investigator: Jay W. Carlson         
United States, Missouri
Capital Region Southwest Campus Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Site Public Contact    573-632-4814    swooden@mail.crmc.org   
Principal Investigator: Bryan A. Faller         
Sponsors and Collaborators
University of Rochester NCORP Research Base
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Investigators
Layout table for investigator information
Principal Investigator: Charles S Kamen, PhD University of Rochester NCORP Research Base
Principal Investigator: Song Yao, PhD Roswell Park Cancer Institute
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Charles Kamen, Associate Professor, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT05364086    
Other Study ID Numbers: URCC21038
NCI-2022-01426 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
URCC21038 ( Other Identifier: University of Rochester NCORP Research Base )
URCC-21038 ( Other Identifier: DCP )
URCC-21038 ( Other Identifier: CTEP )
UG1CA189961 ( U.S. NIH Grant/Contract )
UG3CA260602 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2022    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms