Is NCT05630794 recruiting in Columbus, OH?

Yes, NCT05630794 is currently recruiting participants at its Columbus, OH location. This colorectal adenomatous polyp clinical trial is actively enrolling qualified participants.

How do I join the colorectal adenomatous polyp clinical trial in Columbus?

To join this clinical trial in Columbus, 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 Columbus 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.

Colorectal Adenomatous Polyp Clinical Trial in Columbus, OH

About This Colorectal Adenomatous Polyp Study in Columbus

The purpose of this phase I trial is to test the safety and cancer preventive effects of different doses of ONC201 in people with familial adenomatous polyposis (FAP) or a history of multiple polyps. People with familial adenomatous polyposis (FAP) or a history of multiple polyps are at higher than average risk of developing colorectal cancer. ONC201, now known as dordaviprone, is a drug that may stop cancer cells from growing. This drug has been shown in previous studies to cause cancer cell death but not harm normal cells. If successful, this study may help us develop a new option for colorectal cancer prevention.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Be identified as high risk for recurrent colorectal adenomas, as defined by:

A diagnosis of FAP AND/OR

Findings of either \> 5 small (less than 1 cm) adenomas OR \>= 3 with at least one \>= 10 mm on most recent colonoscopy performed in the past 5 years

Be \>= 18 years of age on day of signing informed consent

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

Leukocytes \>= 3,000/microliter

Absolute neutrophil count \>= 1,000/microliter

Platelets \>= 100,000/microliter

Total bilirubin within normal institutional limits

Aspartate aminotransferase (AST) (serum (glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase (\[SGPT\]) =\< 1.5 x institutional upper limit of normal

Creatinine =\< 1.5 x institutional upper limit of normal

Participant is due to undergo a standard of care lower gastrointestinal (GI) colonoscopy for detection and removal of colorectal polyps. On this colonoscopy, participant is required to have:

Two (2) adenomatous polyps of at least five (5) mm in size

At least one (1) polyp within reach of a flexible sigmoidoscope (which will be retained in the colon or rectum and marked)

In addition to polypectomy, six (6) biopsies of normal colonic mucosa \>= 1 cm from a collected polyp will also be collected

Willing to undergo a second, research intent endoscopic procedure (either sigmoidoscopy or colonoscopy), approximately 12 weeks after initiating ONC201 treatment

Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Life expectancy of at least 5-years

ONC201 is an imipridone agent with the potential for teratogenic or abortifacient effects. For this reason and because imipridones potential teratogenic effects are unknown, 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, for the duration of study participation, and for four weeks after study treatment is completed. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should STOP the study medication and inform her study physician immediately

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Prior history of hereditary nonpolyposis colorectal cancer (HNPCC), also known as Lynch syndrome

Participants may not be currently receiving any other investigational agents or have received any investigational agents within the past four weeks

Prior history of invasive colorectal cancer

Prior invasive active neoplasm that is progressing or requires active treatment within 3 years from registration. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Participants with a history of prior invasive neoplasm diagnosed and treated greater than 3 years form registration may be considered with consultation of the primary investigator

Prior history of exposure to cytotoxic chemotherapy or ONC201

History of allergic reactions attributed to compounds of similar chemical or biologic composition to ONC201

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

Pregnant and women who are nursing are excluded from this study because ONC201 is an imipridone agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with ONC201, breastfeeding should be discontinued if the mother is treated with ONC201

Concomitant use of strong/moderate CYP3A4/5 inducers/inhibitors. These agents must be discontinued at least 72-hours prior to beginning ONC201

Any of the following cardiac criteria:

Prolongation of corrected QT (QTc) interval (QTc interval \> 480 milliseconds, preferably using Frederica's QT correction formula), confirmed on electrocardiogram (ECG) tracings performed during screening

A history of Torsades de pointes, heart failure, or family history of prolonged QT Syndrome

Concomitant use of drugs that are known to prolong QT and have a known risk of torsade de pointes (TdP) unless they are willing to stop these medications and possibly change to an alternative non-excluded medication to treat the same condition at least 72 hours prior to beginning ONC201

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 Columbus?

Yes, this clinical trial (NCT05630794) has an active research site in Columbus, 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.

Colorectal Adenomatous Polyp Treatment Options in Columbus, OH

If you're searching for colorectal adenomatous polyp treatment options in Columbus, OH, this clinical trial (NCT05630794) 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 Columbus research site is actively enrolling participants for this clinical trial. You'll receive care from experienced colorectal adenomatous polyp 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 colorectal adenomatous polyp clinical trials near you to find additional studies recruiting in your area.

Colorectal Adenomatous Polyp Clinical Trial in Columbus, OH

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