Cancer Clinical Trial - Collection of Malignant Ascites, Pleural Fluid, &

Status Completed

Clinical Trial Summary

Background: Researchers want to study fluids and blood of people with cancer. The fluids are from the abdomen and around the lungs. Studying these might help researchers learn about the biology of cancer. This may lead to better ways to treat cancer. Objectives: To study the biology of cancer. Eligibility: Adults 18 and older with malignant solid tumors. Design: Participants will be screened with medical history, blood tests, and confirmation of diagnosis. Participants will have samples taken at regularly scheduled procedures. Fluids from the abdomen and/or lungs will be taken as part of the procedures. Blood will be taken separately. Participants may be asked to give more samples at future procedures. ...

Clinical Trial Description

Background: -Malignant ascites or pleural effusions are often seen in patients with solid tumor malignancies. -Malignant ascites is proinflammatory with many cytokines present and acts to promote tumor cell growth. -The cellular composition of malignant ascites consists of lymphocytes, macrophages and monocytes. -Serum monocytes and lymphocytes play a role in the native host anti-tumor immune mediated mechanisms. -A paracentesis or thoracentesis is often done for symptomatic relief from the malignant fluid collection. Primary Objective: -To obtain blood samples and ascites and pleural effusion samples from patients with solid tumor malignancies, with the intent of performing translational studies related to cancer. Eligibility: - Patients greater than or equal to 18 years of age. - Diagnosis of malignant solid tumor. - Patients must be able and willing to provide informed consent. Design: -We will collect approximately 200cc-5L ascites from patients that are undergoing a therapeutic paracentesis or thoracentesis. No thoracentesis or paracentesis will be performed solely for research purposes. -The fluid will be collected during the medical procedure and may be collected at more than one time point. -We will also collect 30ml of peripheral blood. This will be from patients who are being seen in follow up, consultation, or presenting for enrollment on a clinical trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03189108
Study type	Observational
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Completed
Phase
Start date	May 22, 2017
Completion date	May 18, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Collection of Malignant Ascites, Pleural Fluid, and Blood From People With Solid Tumors

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms