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58 active trials for Pancreatic Neoplasms

Mesothelin-Targeted Immunotoxin LMB-100 Alone or in Combination With Nab-Paclitaxel in People With Previously Treated Metastatic and/or Locally Advanced Pancreatic Ductal Adenocarcinoma and Mesothelin Expressing Solid Tumors

Background: LMB-100 is a man-made protein designed to kill cancer cells. LMB-100 targets a cancer marker called mesothelin. Mesothelin is found on the surface of many different tumors, including pancreatic cancer, but is made by a very small number of normal tissues. Other cancers that make mesothelin include mesothelioma, cholangiocarcinoma, thymic carcinoma, ovarian, lung, gastric, endometrial, cervical, and ampullary cancers. After binding to the mesothelin on tumors, LMB-100 can attack and kill cancer cells. Researchers want to see how well it works when given with and without nab-paclitaxel, a drug which treats pancreatic cancer. Objectives: Arm A- To find a safe dose of LMB-100 with a fixed standard dose of nab-paclitaxel in people with advanced pancreatic cancer. To see how well the combination of the two drugs reduce tumor size. Arm B- To find a safe dose of LMB-100 when it is given as a continuous infusion over several days. Eligibility: Arm A- Adults age 18 and older with advanced pancreatic cancer that has worsened after anti-cancer therapy. Arm B- Adults age 18 and older with advanced pancreatic cancer, mesothelioma or other solid tumor that makes mesothelin that has worsened after anti-cancer therapy Design: Participants will be screened with medical history and physical exam. They will give blood, urine, and tissue samples. They will have scans and x-rays. During each 21-day cycle: For Arm A Participants will get LMB-100 by an intravenous (IV) catheter on days 1, 3, and 5. This is a tube inserted in a vein, usually in the arm. Participants will get nab-paclitaxel by IV on days 1 and 8. For Arm B Participants will get LMB-100 by an IV catheter as a continuous infusion beginning on day 1 and continuing for 2-4 days Some participants will also get nab-paclitaxel by IV on days 1 and 8. All participants will get this combination for up to 2 cycles or until their disease worsens or they have intolerable side effects. Participants will have blood and urine tests and scans throughout the study. Participants will have a safety follow-up visit 3-6 weeks after treatment ends. If their disease remains stable or improves, they will be scanned every 6 weeks until their disease gets worse. Even if their disease gets worse, they or their doctor will be called to talk about their cancer status....

Start: August 2016

Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses

In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at two to three time points during procedures of upper GI, lower GI and hepatobiliary surgery with anastomosis formation in open or laparoscopic surgery. Postoperatively, a detailed software-based assessment of each recording is performed to determine the objective ICG-NIRF perfusion rate before and after anastomosis formation, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak.

Start: March 2020

Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma

The investigators hypothesized that with the administration of the nutritional supplement Ocoxin-Viusid® is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients diagnosed with advanced pancreatic adenocarcinoma, treated at the "Hermanos Ameijeiras" Surgical Clinical Hospital. Phase II clinical trial, open, multicenter, nonrandomized.

Start: October 2018

Discovery of Soluble Biomarkers for Pancreatic Cancer Using Innovative All-Patient Inclusive Methodology

Pancreatic ductal adenocarcinoma (PDAC) remains among cancers with a very poor prognosis (1-year survival <20%). Endoscopic ultrasound with fine needle aspiration (EUS/FNA) is the common examination for all patients with suspicious pancreatic mass. A method was recently developed : it preserves the sanitary sample, named EXPEL, which allows standard pathology examination and OMICS analyzes from the "rinse" liquid. After EUS/FNA in clinical practice, the content of the needle is rinsed in CytoLyt® preservative solution. After cytofiltration, this liquid is systematically discarded. Based on the EXPEL concept, we hypothesise that this all-patients inclusive approach ("Modified EXPEL" procedure) combined with the methodology to access proteomic and metabolomics information in these original samples will allow us to identify a series of clinically useful marker signatures that will ultimately be measurable, non-invasively, in the patient blood.

Start: January 2021

International Pancreatic Surgery Outcomes Study - PancreasGroup.Org

"Snapshot" study worldwide over 3 months in 2021. Provide a verified record of true morbidity and mortality. Identify modifiable predicting factors of outcome. Obtain PubMed citable co-authorship,

Start: January 2021

Comparsion of WT and SNP Techniques of EUS-FNB in Pancreatic Solid Mass (WESP-PSM)

The purpose of this study is to compare the diagnosis accuracy between of wet suction (WS) technique and standard negative pressure (SNP) technique in EUS-FNB by 22G EUS Procore fine needle biopsy?FNB?device for solid pancreatic lesions.

Start: December 2020

Exceptional Responders With Pancreatic Cancer to Chemotherapy

This is an observational study enrolling patients with pancreatic cancer to identify genomic expression differences between exceptional responders and non-responders to standard of care chemotherapy. Data analysis of the gene expression profile of the exceptional responders compared to non-responders will define genomic patterns that may help understand their response to chemotherapy.

Start: October 2015

Fluorouracil and Oxaliplatin as First-line for Advanced Pancreatic Cancer

Patients with locally advanced or metastatic pancreatic adenocarcinoma not eligible for infusional fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX) (PPS 2 or hyperbilirubinemia, among other causes) will be treated with mFLOX regimen (fluorouracil bolus and oxaliplatin). The primary endpoint is to assess the objective response rate according to RECIST criteria (version 1.1) and the secondary endpoints are time until clinical or radiological progression, overall survival, toxicity profile.

Start: August 2016

Prospective Study FNB, Is It Time To Abandon Cytological Assessment

Endoscopic Ultrasound (EUS) is a minimally invasive procedure used by gastroenterologists to examine pancreatic masses and lesions. A fine needle is traversed through an endoscope and used to acquire tissue samples, which are then sent for pathology. The standard approach for diagnosing solid pancreatic lesions has been fine needle aspiration (FNA) (Han et al. 2016). However, the use of FNA comes with its limitations, some of which include multiple needle passes to acquire fluid, the need for on-site cytologists, and decreased diagnostic yield. Fine needle biopsy (FNB) is the latest approach being employed by endosonographers in lieu of FNA. FNB confers several advantages over FNB. First, FNB requires fewer needle passes than FNA to acquire tissue sample for immunohistochemical staining. In addition, FNB provides better tissues samples, greater sensitivity of the tissue core, and thus, improved diagnostic yields (Tian et al. 2018). Finally, FNB is more cost-effective than FNA and relies on pathologists, instead of on-site cytologists, and preserves the tissue core (Tian et al. 2018). The objective of this study is to establish a database of samples placed in formalin for patients who will undergo a fine-needle biopsy (FNB) for pathological evaluation without rapid on site cytological assessment.

Start: October 2021

Contrast-enhanced Diffusion-weighted MRI to Detect Liver Metastases in Patients With Pancreatic Cancer

Given the dismal prognosis of pancreatic cancer, detecting liver metastases early can avoid inappropriate therapy with the associated substantial risks, long-term hospital admissions and high costs, but without survival benefit. The current standard of diagnostic workup with contrast-enhanced CT (CECT) has a poor sensitivity (38-76%) for the detection of liver metastases. As more sophisticated and expensive treatment options emerge, better staging of pancreatic cancer is needed to avoid unnecessary procedures and select the most appropriate treatment strategy. New imaging modalities are available, but their value in staging of pancreatic cancer has not been evaluated yet. Therefore prospective imaging studies are necessary. The main aim of this study is to determine the diagnostic accuracy of contrast-enhanced diffusion-weighted MRI (CE-DW-MRI) in the detection of liver metastases in patients with pancreatic cancer compared to a reference standard of histopathology and follow up imaging. The study is an international, multicenter prospective cohort study (inclusion of patients until 138 patients with liver metastases are included, with a total maximum of 465 patients). Patients with pancreatic cancer will undergo additional CE-DW-MRI within two weeks from the CECT. CECT and CE-DW-MRI will be read independently by two radiologists. Suspected liver lesions on CECT and/or CE-DW-MRI will be biopsied to obtain histopathology as reference standard. For liver lesions without histopathologic proof of metastases a paired follow-up CECT and CE-DW-MRI serve as a composite reference standard. Pancreatic resection will be pursued in patients without proven liver or distant metastases. Patients with locally advanced or metastatic disease will be offered palliative treatment. Follow up CECT and CE-DW-MRI will be performed in all patients at 3, 6, and 12 months.

Start: December 2017

The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer

Aberrant miRNA production has been linked to a wide range of human cancers and shown to play important roles in their genesis and growth. These miRNA can be detected in the blood and tumors of patients with cancer. The investigators hypothesize that the detection of certain miRNAs present in the blood/serum of patients with pancreatic cancer may be important to the early diagnosis of the disease. Furthermore, the investigators hypothesize that miRNA detection in PC patients will yield prognostic information and help predict the response to treatment.

Start: April 2015

A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

The main goal of this study is to screen and detect pancreatic cancer and precursor lesions in individuals with a strong family history or genetic predisposition to pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for Pancreatic Cancer.

Start: November 2016

A Pancreatic Cancer Screening Study in Individuals With New-Onset Diabetes Mellitus

The main goal of this study is to explore the relationship between new-onset diabetes mellitus and a subsequent diagnosis of pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for pancreatic cancer.

Start: January 2018

Laser Tissue Welding - Distal Pancreatectomy Sealing Study

The laser tissue welding device is intended for use in patients requiring sealing of the pancreas after partial pancreatectomy, and including those patients who are fully heparinized or have hemodilutional coagulation failure. The hypothesis is that the laser tissue welding device is safe and effective in sealing the pancreas, thereby decreasing the blood loss (operative and post-operative), and pancreatic juice leakage for patients when the Laser Tissue Welding device is used after pancreatic resection.

Start: January 2018

HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications

Pancreatic resections carry a high risk for complications, especially pancreatic fistula. Both hydrocortisone and pasireotide have been shown to be effective in reducing complications in earlier RCTs. The aim of this study is to compare the effectiveness and safety of these two drugs in preventing complications of pancreatic surgery.

Start: May 2016

The Canadian/US Integrative Oncology Study

This study describes the survival outcomes of advanced stage breast, colorectal, ovarian and pancreatic cancer patients receiving advanced integrative oncology (AIO) treatment at participating North American integrative oncology clinics. This study also aims to describe the integrative treatments recommended by naturopathic doctors (NDs) for these participants alongside their conventional care treatments. Sub-studies will evaluate health-related quality of life, cost of cancer care, and qualitative experience of care in a subset of Canadian participants.

Start: January 2015

UCSF Panc Cyst Registry

Pancreatic cysts are found incidentally on 15-50% of CT and MRIs for all indications and their prevalence is increasing. Many of these cysts may be precursors to pancreatic cancer, and thus pose a substantial risk, however, the vast majority are benign. Increased detection of pancreatic cysts provides an opportunity to diagnose pancreatic malignancy at an early, curable stage yet also increases the potential to over-treat clinically insignificant lesions. This presents a clinical challenge to prevent unnecessary resection of indolent disease, with associated risks of infections, bleeding, diabetes, and costly disability. Unfortunately, there is little information on the epidemiology and natural history of pancreatic cysts to help guide management. This study develops a large, prospectively managed, electronic, patient-directed pancreatic cyst registry based at UCSF using the NIH-funded Eureka Health platform. PANC Cyst will facilitate work to improve clinical care and understanding of pancreatic cysts by prospective follow-up of patients with cystic lesions, especially the diagnostically challenging small cysts, to identify factors related to cyst formation and progression to malignancy. Longitudinal data capture that includes clinical outcomes will also enable us to more precisely define anatomic, radiographic and biomarker information that can be used to differentiate populations of patients for whom surgery is indicated, surveillance is warranted, or no further evaluation is necessary.

Start: October 2019

Fine Needle Biopsy of Solid Pancreatic Mass Lesions

This is a randomized trial to evaluate and directly compare the tissue quality, diagnostic sucess and safety profile of four different Fine Needle Biopsy needles.

Start: September 2019

Pancreatic Anastomosis After Duodenopancreatectomy

A national, multicenter, randomized, prospective, parallel group clinical study to evaluate two therapeutic strategies (invaginating pancreatogastric anastomosis versus Blumgart anastomosis).

Start: June 2020

EUS-FNB With MOSE vs EUS-FNA With ROSE

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an indispensable tool for tissue acquisition for pancreatic lesions. However, FNA alone has several limitations including inadequate acquisition of cells, and unable to provide core tissue for further histological analysis. The use of rapid on-site evaluation (ROSE) by cytopathologist has the biggest impact on improving diagnostic accuracy and is regarded as the gold standard for EUS-FNA. Unfortunately, it is not widely available due to limited resources. In order to overcome these limitations, new fine needle biopsy (FNB) needles have been recently developed to collect not only cells but also the entire core tissue for histological analysis. Having core biopsy with preserved tissue provides additional advantages of allowing molecular analysis, which are of emerging importance in cancer management. Early results comparing FNB with FNA showed the superiority of FNB over FNA in the absence of ROSE. Data comparing FNB and FNA with ROSE are limited. In order to study to true merits of FNB over FNA, comparison with the most optimal method is necessary.

Start: June 2019