Trial Title:
EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer.
NCT ID:
NCT06263088
Condition:
Gastrointestinal Cancer
Colon Cancer
Rectal Cancer
Anal Cancer
Esophageal Cancer
Stomach Cancer
Appendix Cancer
Pancreas Cancer
Liver Cancer
Neuroendocrine Tumors
Conditions: Official terms:
Neuroendocrine Tumors
Gastrointestinal Neoplasms
Pancreatic Neoplasms
Anus Neoplasms
Stomach Neoplasms
Appendiceal Neoplasms
Conditions: Keywords:
Gastrointestinal cancer
African Americans
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single arm study to address the existing disparities faced by Black participants with
gastrointestinal (GI) cancer in accessing crucial biomarker testing, receiving
evidence-based care, and participating in clinical trials.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
EQUITY GI
Description:
1. Ensuring appropriate biomarker testing and evidence-based care: Biomarker testing
can also help choose treatment. Additionally, a tumor board will be conducted
periodically to provide treatment recommendations to the treating physician.
Participant will receive standard-of-care treatment if they enroll in this study.
Participant will not receive any experimental treatment.
2. Assistance with clinical trial enrollment. The study team will help enroll in a
clinical trial appropriate for the condition.
3. Health literacy: The study team will provide information relevant to your diagnosis
to enrich your understanding of your condition and treatment. Investigator will
provide questionnaires to assess your understanding before and after you have been
provided with educational/informational material appropriate for your diagnosis.
Arm group label:
EQUITY GI
Summary:
This research study is being conducted to improve the quality of care of participants who
have a diagnosis of gastrointestinal cancer (anal, colon, rectal, esophageal, stomach,
small bowel, appendix, pancreas, gall bladder, liver, neuroendocrine tumor of
gastrointestinal origin).
This study has 3 components as follows-
1. Ensuring appropriate biomarker testing and evidence-based care: Biomarkers are
molecules in the tumor or blood that indicate normal or abnormal processes in
participant's body and may indicate an underlying condition or disease. Various
molecules, such as DNA (genes), proteins, or hormones, can serve as biomarkers since
they all indicate something about participant's health. Biomarker testing can also
help choose participant's treatment. Additionally, a tumor board will be conducted
periodically to provide treatment recommendations to participant's treating
physician. Participants will receive standard-of-care treatment if participant
enroll in this study. Participant will not receive any experimental treatment.
2. Assistance with clinical trial enrollment. The study team will help participants
enroll in a clinical trial appropriate for participant's condition. However,
enrolling in a clinical trial is totally up to the participant.
3. Health literacy: The study team will provide information relevant to participant's
diagnosis to enrich participant's understanding of participant's condition and
treatment. Investigator will provide questionnaires to assess participant's
understanding before and after participant's have been provided with
educational/informational material appropriate for participant's diagnosis.
Detailed description:
Black individuals, including African Americans, have a disproportionate cancer burden,
including the highest mortality and the lowest survival of any racial/ethnic group for
most cancers.1 Colorectal cancer (CRC), the most common subtype of GI cancer, is the
third most frequently diagnosed cancer among Black men and women.1 Black participants
have a disproportionate gastrointestinal (GI) tract cancer burden compared with White
participants, with a 19% excess risk of cancer death for men and a 13% excess risk for
women.2 Almost two decades after the Institute of Medicine's Unequal Treatment report,3
the treatment gap persists among Black participants with GI cancer across treatment
settings and modalities.4 A National Cancer Database (NCDB)-based analysis suggests that
Black participants with GI cancers are less likely than White participants to achieve
negative surgical margins, undergo adequate lymphadenectomies, and less often receive
adjuvant therapies.4 Similar data demonstrates racial disparities in care and outcomes in
many GI cancer types.5-8 It is important to emphasize that the disparity of cancer care
among Black participants shown in the published studies is likely an underestimate given
that Black participants are less likely to receive appropriate workups leading to a
cancer diagnosis because of the mistrust in the existing system.9 The age-standardized
incidence of various GI cancers, including colon, rectal, liver, intrahepatic bile duct,
stomach, and pancreatic cancers, is projected to rise in the United States (US) in the
coming decades,10 strongly supporting a need for innovative measures to address the care
gap. With this proposed project, investigator seeks to address this troubling disparity
by assessing the extent of the care gap, expanding the biomarker testing and
evidence-based care through the molecular tumor board, and implementing a information
platform integrated with EPIC electronic health record system that will guide providers
to navigate the biomarker-driven therapy and clinical trial enrollment.
University Hospitals Seidman Cancer Center (UH SCC) is a large hybrid academic-community
oncology network that includes the main academic center and 15 community-based cancer
centers. At UH SCC, approximately 2000 participants with GI cancer diagnoses are treated
annually, and 15 % of these participants are Black. Investigator retrospectively reviewed
all cases of CRC, the most prevalent GI cancer, diagnosed in the UH SCC system from April
2020 to March 2022 and found that only 30% of participants underwent all appropriate
biomarker testing. Biomarker testing rates were particularly low in community sites. In
addition, approximately 15% of participants treated for CRC at UH SCC were underserved
minorities, predominantly Black, in whom the rate of biomarker testing was even lower
(20%). These data highlight the urgent need for measures to close the care gap. Our
colleagues at UH SCC in the thoracic oncology group previously demonstrated the
feasibility of improving biomarker testing and implementing biomarker-guided treatment by
utilizing an integrated information platform that tracks the biomarker test results.11
Investigator plans to create a similar integrated information platform for GI cancer
participants, 'EQUITY GI Oncotracker.'
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Adult ≥ 18 years old.
2. Newly diagnosed Black GI cancer participants irrespective of stage. Eligible tumor
types include anal carcinoma, rectal cancer, colon cancer, small bowel cancer,
appendix carcinoma, hepatobiliary cancer, pancreatic cancer, gastroesophageal
cancer, gastrointestinal neuroendocrine tumors, and gastrointestinal stromal tumor.
3. Patient able and willing to comply with study procedures
4. The patient is able to understand and willing to sign and date the written informed
consent form at the screening visit.
Exclusion Criteria:
- NONE
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Contact:
Last name:
Sakti Chakrabarti, MD
Phone:
216-844-3951
Email:
sakti.chakrabarti@uhhospitals.org
Start date:
February 2025
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Case Comprehensive Cancer Center
Agency class:
Other
Source:
Case Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06263088
