Morgantown, WVNCT05430035Now EnrollingIRB Ready

Gallbladder Adenocarcinoma Clinical Trial in Morgantown, WV

Access cutting-edge gallbladder adenocarcinoma treatment through this clinical trial at a research site in Morgantown. Study-provided care at no cost to qualified participants.

Sponsored by West Virginia University

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Expert Care in Morgantown

Access gallbladder adenocarcinoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related gallbladder adenocarcinoma treatment provided free

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Check if you qualify for this gallbladder adenocarcinoma clinical trial in Morgantown, WV

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Why Participate?

  • No-Cost Study Care

  • Local to Morgantown

    Convenient for WV residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Morgantown site if eligible
  4. 4Begin participation

About This Gallbladder Adenocarcinoma Study in Morgantown

Gallbladder adenocarcinoma is a devastating disease associated with a poor prognosis. Gallbladder and other biliary cancers will be responsible for an estimated 11,980 new cases, and 4,090 deaths in the US during 2020. The 5-year survival for all patients with gallbladder cancer is 18%, however this plummets to 2% for patients with metastatic disease. Patients with gallbladder cancer frequently develop peritoneal recurrence, particularly after intra-operative bile spillage during cholecystectomy for incidentally discovered gallbladder malignancy. Once developed, peritoneal metastases are difficult to treat and result in significant morbidity and mortality. As a result, novel approaches that target peritoneal metastases are needed for this disease. Prophylactic use of heated intraperitoneal chemotherapy (HIPEC) has been explored or is under active investigation for numerous gastrointestinal malignancies, including colon, gastric, and appendiceal cancers. HIPEC has efficacy in gallbladder cancer patients with macroscopic peritoneal disease undergoing cytoreductive surgery (CRS)/HIPEC and has been associated with a survival advantage in a multi-institutional retrospective case series. Incidentally discovered gallbladder cancer is treated with central hepatectomy and portal lymphadenectomy, therefore a prophylactic HIPEC can be easily incorporated into the second operation performed as part of the standard of care. In this early phase clinical trial, the investigators will explore the safety and feasibility of prophylactic HIPEC for gallbladder cancer in patients at high-risk of peritoneal recurrence. The primary endpoint is to assess feasibility of the prophylactic heated intraperitoneal chemotherapy (HIPEC) approach in gallbladder cancer. The primary endpoints include occurrence of intra-operative complications, technical challenges, 90-day postoperative morbidity and mortality, length of stay and readmission, which will be documented and compared with historical controls after follow-up.

Sponsor: West Virginia University

Who Can Participate

Inclusion Criteria

Subjects must have histologically or cytologically confirmed gallbladder adenocarcinoma AND inadvertent spillage of bile or intentional decompression during cholecystectomy OR tumors extending through the serosa of the gallbladder (T3/T4) OR poorly differentiated gallbladder adenocarcinoma.
ECOG Performance status ≤ 2
Subjects must have normal organ and marrow function as defined below:
Hemoglobin ≥ 10.0 g/dl
Leukocytes ≥ 3,000/mcL
Absolute neutrophil count ≥ 1,500/mcL
Platelet count ≥ 100,000/mcL
Total bilirubin within normal institutional limits
AST (SGOT) ≤ 2.5 X institutional upper limit of normal
ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
Serum Creatinine within normal institutional limits
Eligible TNM staging includes \>T1b meeting above criteria, any N, and M0
Eligible candidates for standard surgical management which includes central liver resection (+ cholecystectomy if not already performed) and portal lymphadenectomy
Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Prior systemic therapy for gallbladder adenocarcinoma
Subjects receiving any other investigational agents.
Subjects with known or suspected metastatic disease
History of allergic reactions attributed to compounds of similar chemical or biologic composition to MMC or other agents used in this study.
Subjects with 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 or breastfeeding are excluded from this study because MMC has the potential for teratogenic or abortifacient effects. Because there is known risk for adverse events in nursing infants secondary to treatment of the mother with MMC, breastfeeding should be discontinued if the mother is treated with MMC.
Subjects with past medical history of hepatitis B or C
Subjects with evidence of biliary obstruction thought to be cancer related, including subjects requiring biliary stent

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 Morgantown?

Yes, this clinical trial (NCT05430035) has an active research site in Morgantown, WV 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.

Gallbladder Adenocarcinoma Treatment Options in Morgantown, WV

If you're searching for gallbladder adenocarcinoma treatment options in Morgantown, WV, this clinical trial (NCT05430035) 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 Morgantown research site is actively enrolling participants for this clinical trial. You'll receive care from experienced gallbladder adenocarcinoma 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 gallbladder adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

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