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Neoplastic Cells, Circulating clinical trials

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NCT ID: NCT03032913 Completed - Clinical trials for Pancreatic Ductal Adenocarcinoma (PDAC)

Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC

PANC-CTC
Start date: February 15, 2017
Phase:
Study type: Observational

The proposal aims at determining whether liquid biopsy approaches are valid in the diagnosis of pancreatic cancer. Step1 will test 3 CTC isolation methods and analyse by flow cytometry the presence of onco-exosomes in the culture media of pancreatic cell lines. Step 2 will examine the diagnostic accuracy of these blood tumor elements for the diagnosis of cancer of patients with PDAC suspicion or recent diagnosis and their value for disease monitoring.

NCT ID: NCT02974764 Completed - Pancreatic Cancer Clinical Trials

Changes in Biomarkers From Blood Over Time in Patients With Pancreatic Adenocarcinoma

Start date: March 2016
Phase:
Study type: Observational [Patient Registry]

Pancreatic adenocarcinoma (PDAC) is the fourth leading cause of cancer mortality in the United States. The high mortality for these tumors is primarily attributed to the late stage in which most patients are diagnosed, leading to a dismal 5-year survival of 6% for all stages of PDAC. Surgical resection offers the best chance for survival, but most patients only present with symptoms after the tumor has metastasized, and as a result are not operative candidates. This creates a need to both identify patients at an earlier stage while their cancer is still resectable, and predict the aggressiveness of the disease in order to better target treatment. In addition, even patients who receive curative surgery are at a high risk of developing recurrence of disease. Thus, there is also a need to detect recurrence early so appropriate treatment can be provided. As several adjuvant chemotherapeutic regimens are now available, it will be important to identify as soon as possible that the cancer has become refractory to a given therapy. This will allow one to progress to second or third line therapy more quickly while the tumor burden is smaller. This purpose of this study is to identify biomarkers in the blood of patients with PDAC and determine how they can change over time in relation to treatment to assess for any correlation with patient outcomes, response to treatment, recurrence of disease and overall survival. This study will be limited to patients who present to the Johns Hopkins Hospital between January 1, 2015 and December 31, 2018 with PDAC. Blood will be drawn from all consenting patients at the time of initial diagnosis and after treatment. Patients will undergo treatment for their cancer based on personal preference, standard guidelines and discussion with medical, radiation, and surgical oncologists. Patients who undergo surgical resection will also have an additional blood sample collected after resection, and patients who undergo chemotherapy and/or radiation will have an additional blood sample draw at the end of this treatment. A patient could have blood collected at multiple intervals, i.e. a pre-treatment sample, sample post-neoadjuvant chemotherapy/radiation, sample post-surgery, and sample post-adjuvant chemotherapy/radiation. In patients, who have undergone curative resection of PDAC blood samples will be collected till they develop clinical recurrence of disease. For the first 2 years following surgery samples will be collected every 3-4 months. Beyond that the investigators will collect samples every 6 months for the next two years. For all patients found to be alive and disease free beyond 4 years after surgery samples will be collected once every year. These patients will be followed to determine disease-free and overall survival. With this study, the investigators aim to assess the potential utility of blood biomarkers over time for pancreatic tumors which will help both with early detection of disease and also recurrence of disease after surgery. Biomarkers identified would have the potential to create a new method for early diagnosis of patients with PDAC, predict overall survival, response to treatment, or risk of metastatic spread, and predict recurrence of disease, all of which has the potential to drastically improve outcomes for this deadly disease.

NCT ID: NCT02973204 Completed - Clinical trials for Neuroendocrine Tumors

Circulating Tumor Cells and Tumor DNA in HCC and NET

Start date: November 2016
Phase:
Study type: Observational [Patient Registry]

Background Treatment and control of cancer is associated with high costs, to patients in the form of side effects and discomfort during investigations, to society in the form of expensive drugs and studies. Circulating tumor cells (CTC) has received great attention as a cancer biomarker in trying to estimate future course in patients with breast cancer, colon cancer and prostate cancer. CTC is believed to be a crucial step in cancer spreading to the bloodstream and giving rise to metastases. Detection of circulating tumor DNA (ctDNA) specifically adds specificity to the analysis of the CTC. The investigators would like to with molecular biological methods predict which patients requires special monitoring and individualized therapy and explore these tests as clinical decision support. Purpose and method In a blood sample from patients with neuro-endocrine tumor (NET) and hepatocellular carcinoma (HCC), the investigators will by cell separation, flow cytometry and DNA sequencing and digital polymerase chain reaction (PCR): 1. Identify and isolate the CTC and investigate these for tumor-specific mutations. 2. Quantify ctDNA and analyze this for specific mutations, which in the past has been found frequent in NET and HCC. 3. Compare findings of mutations on CTC and ctDNA with mutations in tissue biopsies. The results are compared with the clinical data on disease course, including the effect of treatment and survival. Subjects 40 Patients with small intestinal/unknown primary NET before treatment with somatostatin analogues 30 patients with pancreatic NET before treatment with Everolimus 30 patients with presumed radically treated HCC 30 patients with HCC in treatment with Sorafenib A blood sample will be taken prior to the start of treatment, after 1 month after start of treatment and thereafter every 3.-6. month for up to two years. Perspectives In several cancer types molecular diagnostics have had significant influence in treatment and control strategy. The goal is in future to be able to take advantage of a so-called "liquid biopsy" as clinical decision support. The study will bring new knowledge to this growing field of research.

NCT ID: NCT02955173 Completed - Colorectal Cancer Clinical Trials

Significance of Circulating Tumor Cells in the Treatment of Gastric and Rectal Cancer

Start date: December 2016
Phase: N/A
Study type: Interventional

The primary purpose of this study is to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using CTC as a biomarker.

NCT ID: NCT02941536 Completed - Breast Cancer Clinical Trials

Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Radiotherapy for Metastases of Breast Cancer

Start date: November 1, 2016
Phase: N/A
Study type: Interventional

This study assesses the number of CTCs before and 4-5 weeks after focal stereotactic radiotherapy, in single or fractionated dose, and correlate with the local and distant brain progression-free survival in patients with metastatic breast cancer.

NCT ID: NCT02904161 Completed - Clinical trials for Circulating Tumor Cells (CTCs)

Detection of Circulating Tumor Cells in Peripheral Blood From Healthy Volunteers and Patients With Cancer

Start date: August 2012
Phase: N/A
Study type: Observational

To address the challenges of isolating and analyzing rare cells, this study aims to validate technical diagnostic instrumentation, tests, protocols and analysis to correlate the number of circulating tumor cells present in whole blood for predicting cancer prognosis and treatment efficacy. Investigators propose to enroll and follow cohorts of cancer patients. Blood samples will be collected from these patients at regular intervals as determined by their doctors. The patient's disease progression will be monitored over the lifetime of this study. The specific aims are to isolate, enumerate and analyze the number of circulating tumor cells (CTCs) in patient blood using chip-based sorting, filtration and imaging techniques. Investigators will also use this study to optimize diagnostic instrumentation, test protocols and downstream CTC analysis. Investigators may also correlate the results of these tests with the prognosis of the patients as well as any clinical evidence (e.g. from radiological imaging scans). While investigators focus on prognosis in this study, these correlated tests potentially may also be valuable in future studies for early diagnosis and monitoring of cancer.

NCT ID: NCT02904135 Completed - Clinical trials for Circulating Tumor Cells (CTCs)

Collection of Circulating Tumor Cells From the Peripheral Blood of Metastatic Breast Cancer Patients

Start date: February 2014
Phase: N/A
Study type: Observational

To address the challenges of isolating and analyzing rare cells, this study aims to validate the instrumentation, the test protocols, and the analysis of patient's outcome to show the instrument's capability to reproducibly and accurately detect CTCs in cancer patients. In order to facilitate the validation process, investigators will only focus on metastatic patients for whom CTCs supposedly present at higher abundance. Investigators propose to enroll cohorts of metastatic breast cancer patients. Blood samples will be collected from these patients before they start any new line of therapy as determined by their doctors. The specific aims are to isolate, enumerate and analyze the number and/or molecular information of circulating tumor cells in patient blood using microfluidic chip-based sorting, imaging, and molecular profiling techniques. Investigators will use this study to optimize diagnostic instrumentation, test blood processing protocols and CTC analysis algorithm. During this study investigators will collect patients' clinical information related to cancer, as well as the patients' survival status to validate the system's prognosis ability.

NCT ID: NCT02892786 Completed - Clinical trials for Head and Neck Cancer

Detection in Peripheral Blood of Circulating Tumor Cells in Patient With Head and Neck Squamous Cell Carcinoma

CTCVADS
Start date: December 8, 2010
Phase: N/A
Study type: Interventional

The dissemination of individual tumor cells is a common phenomenon in solid cancers. Detection of tumor cells in peripheral blood circulating tumor cells (CTC) in nonmetastatic situation is of high prognostic significance. The objective of our study was to detect circulating tumor cells in two different method in patient with head and neck squamous cell carcinoma .

NCT ID: NCT02827344 Completed - Lung Cancer Clinical Trials

PDL-1 Expression on Circulating Tumor Cells in Non-small Cell Lung Cancer

IMMUNO-PREDICT
Start date: October 1, 2015
Phase:
Study type: Observational

Immunotherapy is probably, since the development of therapies targeting EGFR mutations or ALK rearrangement, the most attractive therapeutic perspective in the management of metastatic lung cancer. Among the compounds tested, the inhibitors of the immune checkpoint PROGRAMME DEATH 1 / PROGRAMME DEATH LIGAND 1 (PD-1/PD-L1) have been tested in numerous clinical trials with recently published positive results leading to the approval of one drug in the USA and an expanded access program for two drugs in France. PROGRAMME DEATH LIGAND 1 (PD-L1) expression by tumor cells is strongly associated with the response to such molecules so that the participation in various clinical trials is currently reserved for patients expressing this biomarker and therefore justifies a new invasive biopsy (bronchoscopic or CT-guided) representing a considerable drag on the access to these treatments. Circulating tumor cells (CTCs) isolated by Isolation by Size of Tumor Cells (ISET) offer a direct and non-invasive access to the tumor. It has already been demonstrated that molecular characterization (EGFR, ALK) on these blood samples is possible. We propose to demonstrate the feasibility of the analysis PDL-1 expression in these cells by immunocytochemistry. Myeloid-Derived Suppressor Cells (MDSCs) are immature myeloid cells that inhibit T cell functions and thus promote tumor growth. These cells frequently express PD-L1. We propose to test whether MDSCs level and its evolution during treatment with PD1 inhibitor is correlated to the response to these drugs. The main objective of this study is to demonstrate the feasibility of the analysis of PD-L1 expression on CTC

NCT ID: NCT02812680 Completed - Esophageal Cancer Clinical Trials

The Utility of Circulating Tumour Cells and Plasma microRNA in Esophageal Adenocarcinoma

Start date: June 2016
Phase:
Study type: Observational

Circulating microRNA (circ miRNA) and circulating tumor cell (CTC) levels are hypothesized to be associated with response to chemoradiation in patients undergoing treatment for locally advanced esophageal adenocarcinoma. The goal of this project is to assess the use of circulating microRNA (miRNA) and circulating tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy.