Is NCT04939051 recruiting in Cleveland, OH?

Yes, NCT04939051 is currently recruiting participants at its Cleveland, OH location. This barrett esophagus clinical trial is actively enrolling qualified participants.

How do I join the barrett esophagus clinical trial in Cleveland?

To join this clinical trial in Cleveland, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Cleveland clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Barrett Esophagus Clinical Trial in Cleveland, OH

About This Barrett Esophagus Study in Cleveland

This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to neoplastic progression in Barrett's esophagus. Obeticholic acid has shown anti-cholestatic, anti-inflammatory and anti-fibrotic effects mediated by FXR activation. It down regulates bile acid availability and decreases proinflammatory cytokine production including IL-1beta and TNFalpha in human enterocytes and immune cells. This chain of events reduces the bile acid exposure in esophagus tissue thereby limiting bile acid induced damage and dysplastic progression.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Known diagnosis of histologically-confirmed BE with either no dysplasia, indefinite for dysplasia, or low-grade dysplasia as defined by the presence of specialized columnar epithelium on histology and \>= 2 cm of involvement on endoscopy

Adequate Barrett's mucosa, which is defined as at least one sample with \>= 50% intestinal metaplasia in biopsies required to satisfy the endpoints of the study

Participants are on proton pump inhibitors (PPI) therapy for \>= 28 days duration

Age \>= of 18 years. Because no dosing or adverse event (AE) data are currently available on the use of OCA in participants \< 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable

Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)

Hemoglobin \>= 10g/dL or hematocrit \>= 30 %

Leukocyte count \>= 3,500/microliter

Platelet count \>= 100,000/microliter

Creatinine clearance (calculated if measured is not available) \>= 30mL/min/1.73m\^2

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 X institutional upper limit of normal (ULN)

Total bilirubin =\< 1.0 X ULN

Alkaline phosphatase =\<1.5 X ULN

Gamma-glutamyl transferase (GGT) =\< 1.5 X ULN

The effects of OCA on the developing human fetus are unknown. For this reason, all men and women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, throughout the duration of study participation, and for at least 6 months after receiving the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately

Ability to understand the study procedures, benefits and risks, and sign a written informed consent document. Non-English speaking participants are allowed to enroll even if they skip answering quality-of-life (QOL) questionnaires. Special efforts will be made through community advisory boards at participating sites to reach Spanish speaking participants

Willing to undergo testing for human immunodeficiency virus (HIV) testing if not tested within the past 6 months

Willing to undergo hepatitis B and C screening if not tested within the past 6 months

Willing and able to adhere to the prohibitions and restrictions specified in the approved protocol

Willingness to moderate alcohol intake (consuming no more than 1 or 2 alcoholic drinks per day for women and men, respectively)

Participants must have no evidence of active or recurrent invasive cancer for 6 months prior to screening and must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation)

Exclusion Criteria

History of prior ablative therapy such as radiofrequency ablation, cryotherapy or argon plasma coagulation (APC) in BE segment

Prior use of OCA

Prior history or presence of high-grade disease (HGD) or cancer on pre-intervention endoscopy

Cutaneous diseases manifesting with severe pruritus

Individuals with active, known or suspected chronic liver disease including cirrhosis, nonalcoholic steatohepatitis (NASH) with fibrosis or cirrhosis, primary sclerosing cholangitis, biliary atresia

Individuals with acute cholecystitis (defined by a syndrome of right upper quadrant pain, fever, and leukocytosis associated with gallbladder inflammation)

Individuals with a history of pancreatitis or pancreatic abnormalities

Individuals with hepatic steatosis and velocity \> 1.7 m/sec as determined by liver ultrasound elastography. Results of a right upper quadrant ultrasound with elastography performed within 6 months of starting study treatment may be used to assess this criteria

Individuals with hyperlipidemia that is not well controlled with the use of pharmacotherapy and/or dietary modifications

History of severe, progressive, or uncontrolled renal, genitourinary, hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof

Individuals with known hypersensitivity, allergies, or intolerance to the study drug or compounds of similar chemical or biologic composition

Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Individuals with active and untreated hepatitis C virus (HCV) and/or or hepatitis B virus (HBV) infection

Individuals with HIV infection are eligible for participation if:

CD4+ count \>= 300/uL

Viral load is undetectable

Receiving highly active antiretroviral therapy (HAART) without known or suspected drug interactions with OCA

Consultation with the participant's infectious disease specialist may be obtained

Individuals taking the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than 5 half-lives days prior to starting OCA or placebo on this study. Consultation with the participant's primary care provider may be obtained but is not required.

The use of the following drugs or drug classes is prohibited during OCA/placebo treatment

Investigational agents;

Bile acid sequestrants (bile acid binding resins): cholestyramine, colestipol, or colesevelam;

Bile salt efflux pump (BSEP) inhibitors;

Theophylline derivatives;

Tizanidine;

Hepatotoxic drugs such as amiodarone, sodium valproate, certain herbal/dietary supplements, and long-term doxycycline or tetracycline

Pregnant, breast-feeding, or women of childbearing potential unwilling to use a reliable contraceptive method. Pregnant women are excluded from this study because OCA is an agent with unknown effects on the developing human fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OCA, breastfeeding should be discontinued if the mother is treated with OCA

Participants may not be receiving any other investigational agents

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cleveland?

Yes, this clinical trial (NCT04939051) has an active research site in Cleveland, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Barrett Esophagus Treatment Options in Cleveland, OH

If you're searching for barrett esophagus treatment options in Cleveland, OH, this clinical trial (NCT04939051) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cleveland research site is actively enrolling participants for this clinical trial. You'll receive care from experienced barrett esophagus specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all barrett esophagus clinical trials near you to find additional studies recruiting in your area.

Barrett Esophagus Clinical Trial in Cleveland, OH

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