Collection of Malignant Ascites, Pleural Fluid, and Blood From People With Solid Tumors
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed 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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Cohort 1 Patients with a diagnosis of malignant solid tumor |
Outcome Measures
Primary Outcome Measures
- To obtain blood samples, ascites and pleural effusion samples from patients with solid tumor malignancies, with the intent of performing translational studies related to cancer. [Ongoing]
Experimental - Translational study outcomes from the collection/analysis of blood samples; and ascites and pleural effusion samples from patients with solid tumor malignancies.
Secondary Outcome Measures
- Develop the malignant fluid as a culture model to replicate intraperitoneal growth of ovarian cancers. [ongoing]
- Characterize malignant effusion composition through immunohistochemistry and flow cytometry. [ongoing]
- Compare immune cell phenotype in ascites and blood from the patient. [ongoing]
- Study in vivo characteristics of matched tumor cells and peripheral blood leukocytes from the same patient in xenograft models [ongoing]
- Establish a bank of clinically annotated samples for translational science. [ongoing]
- Compare selected matched sets of samples from the same patient to evaluate both for treatment response. [ongoing]
Eligibility Criteria
Criteria
-
INCLUSION CRITERIA:
-
Participants greater than or equal to 18 years of age with histologically proven malignant solid tumors
-
Ability and willingness to provide informed consent to participation.
-
Participants with malignant solid tumors with a clinical indication for a thoracentesis or paracentesis.
EXCLUSION CRITERIA:
-Children < 18 years of age are not eligible.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | National Institutes of Health Clinical Center | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Christina M Annunziata, M.D., National Cancer Institute (NCI)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 170100
- 17-C-0100