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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03189108
• Other study ID #: 170100
• Secondary ID: 17-C-0100
• Status: Completed
• Start date: May 22, 2017
• Est. completion date: May 18, 2023

Study information

• Verified date: September 29, 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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. ...

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 18, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Ascites
• Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Primary Peritoneal Cancer

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Experimental - Translational study outcomes from the collection/analysis of blood samples; and ascites and pleural effusion samples from patients with solid tumor malignancies.	Ongoing
Secondary	Develop the malignant fluid as a culture model to replicate intraperitoneal growth of ovarian cancers.		ongoing
Secondary	Characterize malignant effusion composition through immunohistochemistry and flow cytometry.		ongoing
Secondary	Compare immune cell phenotype in ascites and blood from the patient.		ongoing
Secondary	Study in vivo characteristics of matched tumor cells and peripheral blood leukocytes from the same patient in xenograft models		ongoing
Secondary	Establish a bank of clinically annotated samples for translational science.		ongoing
Secondary	Compare selected matched sets of samples from the same patient to evaluate both for treatment response.		ongoing

External Links

•   NIH Clinical Center Detailed Web Page