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

Trial Summary

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 safety data exists for treatments related to gastrointestinal cancer?

Some treatments for gastrointestinal cancer, like immune checkpoint inhibitors, can cause side effects such as diarrhea and colitis (inflammation of the colon), which can range from mild to severe. It's important for doctors to be aware of these potential issues to manage them effectively. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Sakti Chakrabarti, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Association of polypectomy techniques, endoscopist volume, and facility type with colonoscopy complications. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Meta-Analysis of Regorafenib-Associated Adverse Events and Their Management in Colorectal and Gastrointestinal Stromal Cancers. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Immune checkpoint inhibitor-related luminal GI adverse events. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The economic burden of common adverse events associated with metastatic colorectal cancer treatment in the United States. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Novel classification for adverse events in GI endoscopy: the AGREE classification. [2023]