Is NCT05961982 recruiting in Columbus, OH?

Yes, NCT05961982 is currently recruiting participants at its Columbus, OH location. This pancreatic neoplasm clinical trial is actively enrolling qualified participants.

How do I join the pancreatic neoplasm 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.

Pancreatic Neoplasm Clinical Trial in Columbus, OH

About This Pancreatic Neoplasm Study in Columbus

This clinical trial evaluates the safety and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for the management of patients with pancreatic tumors (including cysts) performed during recommended surveillance endoscopic ultrasound examinations. Pancreatic tumors (cysts) can progress to pancreatic cancer at rate of more than 25% per year risk. Pancreatic cancer is a fatal disease that is difficult to diagnose at an early stage, and the five-year survival rate is currently less than 10%. It is projected to be the second leading cause of cancer-related mortality by the year 2030. A procedure known as radiofrequency ablation may help. Radiofrequency ablation is an established way to treat benign and cancerous tumors in the human body. In the last 5 years, radiofrequency ablation has been applied to treat precancerous tumors (including cysts) in the pancreas. This procedure implements a medical technology that destroys tumors in a much less invasive way compared to traditional surgical removal. By delivering a high-frequency alternating current, radiofrequency ablation uses electrical energy and heat to destroy cancer cells. Radiofrequency ablation is being recognized as a management option in patients with high-risk pancreatic tumors (cysts) but are not deemed surgical candidates. While surgical removal offers a chance of cure, pancreatic surgeries have 20-40% morbidity rate (short and long-term complication) and a 1-2% mortality rate in patients who are surgical candidates. Furthermore, radiofrequency ablation can potentially decrease the need for frequent imaging/surveillance of the pancreatic tumor (cyst). In patients with immediate prohibitive, but reversible risks for surgery, radiofrequency ablation of a high-risk tumors (cysts) can potentially prevent further progression of the lesion and bridge the time before the need for surgical resection.

Sponsor: Ohio State University Comprehensive Cancer Center

Who Can Participate

Inclusion Criteria

Age \> 18 years

A diagnosis of a PCN confirmed by EUS-FNA including cyst fluid next generation sequencing (NGS) and/or EUS-guided needle-based confocal laser endomicroscopy (nCLE) and/or EUS- guided through-the-needle biopsy (TTNB)

The pancreatic cystic lesion (PCL) measures at least 2 cm in diameter on either CT or MRI/MRCP or EUS and demonstrates concerning worrisome and/or high-risk features as defined by International Consensus Guidelines (2017 revised Fukuoka Guidelines)

The patient is not a surgical candidate. Common clinical scenarios include -

Cirrhosis of the liver (common clinical scenario)

Advanced ( \>= 75 years) age (common clinical scenario)

Morbid obesity

Significant cardiorespiratory comorbidity

Patient's choice (patient elects for non-surgical management)

Other significant comorbid conditions that impose prohibitive surgical risks

Estimated life expectancy of at least 1 year

Capable of giving written informed consent or has a legally authorized representative (LAR) to consent for them

Women of childbearing potential must have a negative pregnancy test (serum/urine) on the day of treatment. Pregnancy testing is the routine standard of care practice in the endoscopy laboratory for all patients undergoing endoscopy and sedation for endoscopy

The patient prefers non-surgical management after consultation with hepato-pancreato-biliary (HPB) surgery

The patient is not a surgical candidate and has had prior attempts at ablation of the PCN by EUS-guided injection of chemotherapy (Ohio State University \[OSU\] Institutional Review Board \[IRB\] protocol 2020C0198)

Exclusion Criteria

A diagnosis of a benign or non-neoplastic PCL such as a pseudocyst confirmed by EUS-FNA including cyst fluid NGS and/or EUS-nCLE and/or EUS-TTNB

A diagnosis of a malignant PCN confirmed by evidence of adenocarcinoma and/or invasive carcinoma and/or distant metastases

Cysts or neuroendocrine tumors (NETS) involving or in close proximity to blood vessels, the biliary tree, or the main pancreatic duct where the zone of ablation is likely to compromise these structures

Acute pancreatitis in the preceding 4 weeks prior to date of EUS-RFA

Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it unsafe for the patient to participate in the study

Any psychiatric disorder making reliable informed consent impossible

Pregnancy or breast-feeding

Eastern Cooperative Oncology Group (ECOG) performance status 4

Contraindication to general anesthesia after review by OSU Preoperative Assessment Clinic (OPAC)

Cardiac implantable electrical devices

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 (NCT05961982) 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.

Pancreatic Neoplasm Treatment Options in Columbus, OH

If you're searching for pancreatic neoplasm treatment options in Columbus, OH, this clinical trial (NCT05961982) 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 pancreatic neoplasm 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 pancreatic neoplasm clinical trials near you to find additional studies recruiting in your area.

Pancreatic Neoplasm Clinical Trial in Columbus, OH

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