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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03189108
Enrollment
22
Registered
2017-06-16
Start date
2017-05-22
Completion date
2023-05-18
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer

Keywords

Malignant Effusion Composition, Paracentesis, Thoracentesis, Natural History

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.

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.

Interventions

None listed

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
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.OngoingExperimental - Translational study outcomes from the collection/analysis of blood samples; and ascites and pleural effusion samples from patients with solid tumor malignancies.

Secondary

MeasureTime frame
Characterize malignant effusion composition through immunohistochemistry and flow cytometry.ongoing
Compare immune cell phenotype in ascites and blood from the patient.ongoing
Develop the malignant fluid as a culture model to replicate intraperitoneal growth of ovarian cancers.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
Study in vivo characteristics of matched tumor cells and peripheral blood leukocytes from the same patient in xenograft modelsongoing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026