An interventional study of EQUITY GI in Gastrointestinal Cancer, Colon Cancer and Rectal Cancer, sponsored by Case Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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-
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.'
695 studies on the registry are indexed under Gastrointestinal Neoplasms; 209 are open to participants now.
This study's planned enrollment of 200 is above the median of 74 across 494 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Case Comprehensive Cancer Center is the lead sponsor of 494 studies on the registry; 61 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Data gathering 2. Program development and implementation 3. Health literacy
Other: EQUITY GI
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.
Biomarker testing rate of Black participants diagnosed with GI cancer
The biomarker testing rate will be estimated based on the number of cases (i.e., participants taking the biomarker testing) using a binomial distribution, and their confidence intervals will be estimated using Wilson's method.23 Potential predictors of the binary outcomes will be identified using multivariable logistic regression.
Time frame: 24 months
Clinical trial enrollment rate among black participants diagnosed with GI cancer
The clinical trial enrollment rate will be estimated based on the number of cases (i.e., participants enrolled in clinical trials) using a binomial distribution, and their confidence intervals will be estimated using Wilson's method.23 Potential predictors of the binary outcomes will be identified using multivariable logistic regression.
Time frame: 24 months
Change in Health literacy test among black participants diagnosed with GI cancer
The evaluation of literacy will be conducted using the CHLT-6 questionnaire, a six-item test designed for assessing cancer health literacy measured before and after the intervention with the goal of increasing the mean score by 30%.
Time frame: 24 months
Change in Health literacy score among black participants diagnosed with GI cancer
The evaluation of literacy will be conducted using the CHLT-30 questionnaire, a thirty-item test designed for assessing cancer health literacy measured before and after the intervention with the goal of increasing the mean score by 30%.
Time frame: 24 months
Plan to share: Yes
Supporting information: Study protocol, Clinical study report
Time frame: Until 2026
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