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



Status:Recruiting
Conditions:Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - 99
Updated:7/22/2018
Start Date:May 22, 2017
End Date:January 4, 2028
Contact:Irene Ekwede, R.N.
Email:ekwedeib@mail.nih.gov
Phone:(240) 760-6126

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

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.

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.

- INCLUSION CRITERIA:

- Patients greater than or equal to 18 years of age with histologically proven malignant
solid tumors

- Ability and willingness to provide informed consent to participation.

- Patients with malignant solid tumors with a clinical indication for a thoracentesis or
paracentesis.

EXCLUSION CRITERIA:

- Children < 18 years of age are not eligible.

- Recruitment strategies

All patients undergoing screening for trials, being seen in follow up, consultation, or
presenting for enrollment on a clinical trial in the Women s Cancer Clinic of the NCI will
be screened for this protocol.

- SCREENING EVALUATION

- Baseline history, including age, performance status, and dates of prior treatment
regimens.

- Report of tumor histology (outside reports are acceptable).
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
301-496-2563
Phone: 888-624-1937
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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mi
from
Bethesda, MD
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