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RecruitingNCT06263088Updated Sep 15, 2026

EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer.

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

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.'

02

Conditions studied

  • Gastrointestinal Cancer
  • Colon Cancer
  • Rectal Cancer
  • Anal Cancer
  • Esophageal Cancer
  • Stomach Cancer
  • Appendix Cancer
  • Pancreas Cancer
  • Liver Cancer
  • Neuroendocrine Tumors

Keywords

  • Gastrointestinal cancer
  • African Americans
03

In context

Gastrointestinal Neoplasms

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

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 form at the screening visit.

Exclusion criteria

Exclusion Criteria:

  • NONE
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Other
    EQUITY GI

    1. Data gathering 2. Program development and implementation 3. Health literacy

    Other: EQUITY GI

Interventions

  • OtherEQUITY 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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Clinical study report

Time frame: Until 2026

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06263088
Responsible party
Sponsor
First posted
Feb 16, 2024
Start date
Dec 1, 2024
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Sep 15, 2026

Study contacts

Amit Mahipal, MBBS
Contact
amit.mahipal@uhhospitals.org
216-844-3951
Amit Mahipal, MBBS
principal investigator · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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