EQUITY GI for Gastrointestinal Cancer

Overseen By Sakti Chakrabarti, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance the quality of care for individuals diagnosed with gastrointestinal cancer, such as colon, stomach, or liver cancer. It focuses on ensuring proper biomarker testing, which helps doctors choose the best treatment by analyzing molecules in the tumor or blood. Participants receive standard care and additional support, including assistance with enrolling in other clinical trials and educational materials to improve their understanding of their condition. The trial is well-suited for Black adults who have been recently diagnosed with gastrointestinal cancer and are willing to follow study procedures. As an unphased trial, it offers participants the opportunity to contribute to research that could improve cancer care for future patients.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. Since participants will receive standard-of-care treatment, it's likely you can continue your current medications, but you should confirm with the study team.

What prior data suggests that this protocol is safe for participants with gastrointestinal cancer?

Research has shown that the EQUITY GI study aims to improve care for people with gastrointestinal cancer. This study does not test new drugs or treatments, so participants face no safety concerns related to new medicines. Instead, it focuses on enhancing care through biomarker testing and patient education.

Participants will receive standard treatments for their cancer, meaning they will undergo treatments already approved and commonly used for their condition. Thus, joining this study involves no new safety risks.

In summary, the EQUITY GI study seeks to improve care and understanding, not to test new drugs, so safety concerns about experimental treatments do not apply. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EQUITY GI trial for gastrointestinal cancer because it focuses on a comprehensive approach involving data gathering, program development, and enhancing health literacy, which is different from the usual reliance on chemotherapy, radiation, or surgical interventions. Unlike traditional treatments that primarily target the cancer cells directly, this method aims to empower patients through education and tailored healthcare strategies, potentially improving outcomes by addressing social and educational barriers to effective treatment. This approach could lead to more personalized and accessible care, making it a promising area of exploration for improving patient quality of life and treatment success.

What evidence suggests that this trial's components could improve care for gastrointestinal cancer?

The EQUITY GI study aims to improve care for people with gastrointestinal (GI) cancer by addressing disparities in healthcare, particularly in biomarker testing. Biomarkers are substances in the body that can signal a disease. This study does not test new treatments but ensures that patients receive care based on the latest research. The goal is to ensure everyone receives the right tests and treatments, thereby improving overall care quality. Although no new drugs are tested, the study focuses on understanding and enhancing current care practices. ^{2 6 7 8 9}

Who Is on the Research Team?

Sakti Chakrabarti, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for Black adults aged 18 or older who have been newly diagnosed with various types of gastrointestinal cancers, including those affecting the colon, rectum, stomach, pancreas, liver and more. Participants must be able to follow study procedures and give informed consent.

Inclusion Criteria

Patient able and willing to comply with study procedures

The patient is able to understand and willing to sign and date the written informed consent form at the screening visit.

I am Black and have a newly diagnosed GI cancer.

Exclusion Criteria

I meet the criteria as there are no restrictions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biomarker Testing and Evidence-Based Care

Ensuring appropriate biomarker testing and evidence-based care through a molecular tumor board and standard-of-care treatment

24 months

Clinical Trial Enrollment Assistance

Assistance with enrolling participants in appropriate clinical trials

24 months

Health Literacy Improvement

Providing educational materials and assessing health literacy to improve understanding of diagnosis and treatment

24 months

Follow-up

Participants are monitored for safety and effectiveness after interventions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EQUITY GI

Trial Overview

EQUITY GI aims to improve care quality by ensuring proper biomarker testing for personalized treatment plans and assisting with clinical trial enrollment. It also focuses on enhancing health literacy through educational materials about participants' conditions.

How Is the Trial Designed?

Group I: EQUITY GI Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

In a study of 4,158 metastatic colorectal cancer patients, the most expensive adverse events (AEs) associated with treatment were hematologic issues, costing an average of $1,480 per month, followed by respiratory and endocrine/metabolic AEs.

The research highlights that these AEs significantly increase healthcare costs during treatment episodes, emphasizing the need for effective management strategies to minimize their impact on patient care and healthcare resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The economic burden of common adverse events associated with metastatic colorectal cancer treatment in the United States. Latremouille-Viau, D., Chang, J., Guerin, A., et al.[2017]

A study of over 2.3 million outpatient colonoscopies revealed that more complex polypectomy techniques, such as snares and hot forceps, significantly increase the risk of serious gastrointestinal adverse events like colonic perforations and GI bleeding compared to simple colonoscopy.

Patients treated by low-volume endoscopists and those undergoing procedures in ambulatory surgery centers also faced higher risks of complications, suggesting that opting for simpler techniques or high-volume specialists could help reduce these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of polypectomy techniques, endoscopist volume, and facility type with colonoscopy complications. Chukmaitov, A., Bradley, CJ., Dahman, B., et al.[2023]

Adverse events (AEs) related to regorafenib are significantly more common in patients under 65 years old and are strongly correlated with the higher starting dose of 160 mg, suggesting that younger patients may be at greater risk.

Lowering the regorafenib dose to 120 mg may reduce the incidence of AEs while maintaining efficacy, as 57% of patients recovered from AEs after dose adjustments, indicating the importance of monitoring and managing side effects for continued treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-Analysis of Regorafenib-Associated Adverse Events and Their Management in Colorectal and Gastrointestinal Stromal Cancers. Xie, G., Gong, Y., Wu, S., et al.[2020]

The AGREE classification system for adverse events in gastrointestinal (GI) endoscopy was validated and showed an 80% agreement in severity perception among endoscopists, nurses, and patients, indicating its reliability.

The AGREE classification correlated significantly with the established ASGE classification, and was deemed simple, reproducible, and useful by 96% of experts, suggesting it can enhance the standardization and quality assurance of AE reporting in GI endoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel classification for adverse events in GI endoscopy: the AGREE classification. Nass, KJ., Zwager, LW., van der Vlugt, M., et al.[2023]

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