Archives: Clinical Trials

The purpose of this study is to prospectively determine the effects of administering proton pump inhibitors (PPIs) following pancreaticoduodenectomy on postoperative outcomes. The findings of this study will help in avoiding the widespread use of PPIs during the immediate postoperative period following pancreatic surgery.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced cancer.

The goal of this observational study is to use endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) to investigate the intratumoral microbiome profile in patients with pancreatic ductal adenocarcinoma (PDAC) and to evaluate its potential impact on tumor diagnosis and prognosis. PDAC is the most common and lethal type of pancreatic cancer, accounting for over 85% of all pancreatic cancer cases. Given that most patients are diagnosed at an advanced stage when surgery is no longer an option, EUS-FNB serves as a crucial and minimally invasive method for accessing and analyzing the microbiome within the tumor.

The main questions this study aims to answer are:

Can EUS-FNB reliably and accurately detect the microbiome within PDAC tumors?

Researchers will analyze tissue samples obtained through EUS-FNB to confirm its ability to accurately capture the diversity and composition of the tumor microbiome.

Are there specific microbes or metabolites within the PDAC tumor microbiome that are linked to patient prognosis or response to chemotherapy?

The study will screen for and identify key microbial species or metabolites associated with treatment outcomes and patient survival in PDAC.

To ensure the reliability of the EUS-FNB results, researchers will systematically compare microbiome data obtained from EUS-FNB samples with those from surgical biopsies of pancreatic cancer tissue. This comparison will help validate the consistency and accuracy of the two methods in identifying the microbiome diversity and composition, confirming the clinical and research utility of EUS-FNB.

Participant Requirements:

Participants will be patients diagnosed with PDAC who require EUS-FNB as part of their clinical assessment and treatment pathway.

During the EUS-FNB procedure, researchers will use the remaining tissue after rapid on-site evaluation (ROSE) to conduct microbiome sequencing, ensuring sample quality.

All participants will provide informed consent, allowing the use of leftover tissue for microbiome analysis, and their privacy will be strictly protected throughout the study.

Study Procedures:

Participants will undergo a standard EUS-FNB procedure as part of their routine clinical care, with no additional procedures required for the study.

Researchers will compare the microbiome characteristics from EUS-FNB samples with those from surgical biopsy samples to verify consistency.

The study will utilize 2bRAD-M metagenomic sequencing technology, which is cost-effective and suitable for low-biomass, host-contaminated, and degraded microbiome samples. This method generates an accurate species-level taxonomic profile for analysis.

By identifying key microbial components or metabolites linked to patient prognosis or treatment response, this study aims to provide scientific evidence for early detection strategies and effective treatment plans for PDAC patients, potentially bringing significant clinical benefits.

The purpose of this study is to investigate whether the addition of panitumumab to radiotherapy plus gemcitabine will increase the number of patients who are alive and progression free at 7 months.

The FIBROPANC-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (>25%) of developing post operative pancreatic fistula (POPF). A single course of 12Gy preoperative radiotherapy may lead to sufficient fibrosis in a small (4cm) targeted area, thereby reducing the risk of grade B and C POPF.

This is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. And the independent review committee (IRC) will be formed to monitor efficacy data through the study.

Since patients with metastatic pancreatic cancer have a limited life expectancy, it is important to determine the timing of when to start chemotherapy in order to optimize the benefits of chemotherapy relative to the side effects. Therefore, two treatment strategies can be considered: chemotherapy started immediately at diagnosis, or delayed until disease-related symptoms occur.

Background:

Many advances have been made in cancer treatments, but more research is needed. Comparing samples of cancerous tissue to samples of normal, noncancerous tissues may help find differences between them. These differences may help researchers find new ways to treat cancer.

Objective:

To collect tissues and blood samples from people with known or suspected cancer. The samples will be used to help identify new targets for cancer treatments.

Eligibility:

People aged 18 years and older with a known or suspected cancer that requires surgery or biopsy.

Design:

Participants will be screened. They will answer questions about their health. They can do this on the phone or in person.

Researchers will collect information from participants medical records. Data may include information about any prior or current cancers. Data about other medical conditions may also be collected.

Participants will have blood drawn. Some of the blood will be tested for HIV and hepatitis B and C. Some of the blood will be used for genetic research.

Participants will have tissue samples collected during surgeries or biopsies. These are procedures the participants would have had as part of their standard care. No new procedures will be done just for this study. Researchers may also seek out samples from prior procedures the participant had done.

Participants will remain in the study for 6 months. They may have blood drawn again. Researchers may also collect tissue samples from any procedures performed during that time.

The goal of this study is to partner with individuals known or suspected to have pancreatic cancer to build a biobank dedicated to minimizing disparities and personalizing care for individuals affected by pancreatic cancer. A biobank is a resource that involves collection, processing and storage of blood, other bodily fluids, and tissue.

The goal of this Phase 1 clinical research study is to find the highest safe dose of BIND-014 that can be given in the treatment of patients with advanced or metastatic cancer.