Collection of Malignant Ascites, Pleural Fluid, and Blood From People With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03189108|
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : February 14, 2018
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.
To study the biology of cancer.
Adults 18 and older with malignant solid tumors.
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|
|Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer Cancer|
-Malignant ascites or pleural effusions are often seen in patients with solid tumor
-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
-Serum monocytes and lymphocytes play a role in the native host anti-tumor immune
-A paracentesis or thoracentesis is often done for symptomatic relief from the malignant
-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.
- 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.
-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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Collection of Malignant Ascites, Pleural Fluid, and Blood From Patients With Solid Tumors|
|Actual Study Start Date :||May 22, 2017|
|Estimated Primary Completion Date :||January 4, 2027|
|Estimated Study Completion Date :||January 4, 2028|
Adults with Solid Tumors
Adult patients with solid tumor malignancies and ascites that requires therapeutic paracentesis or pleural effusion requiring thoracentesis
- 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 [ Time Frame: Ongoing ]
- Develop the malignant fluid as a culture model to replicate intraperitoneal growth of ovarian cancers. [ Time Frame: ongoing ]
- Characterize malignant effusion composition through immunohistochemistry and flow cytometry. [ Time Frame: ongoing ]
- Compare immune cell phenotype in ascites and blood from the patient. [ Time Frame: ongoing ]
- Study in vivo characteristics of matched sets of samples from the same patient to evaluate both for treatment response [ Time Frame: ongoing ]
- Establish a bank of clinically annotated samples for translational science. [ Time Frame: ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189108
|Contact: Irene Ekwede, R.N.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Christina M Annunziata, M.D.||National Cancer Institute (NCI)|