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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03189108

Collaborator

(none)

500

Enrollment

Location

127.4

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

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
Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer Cancer

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

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 22, 2017

Anticipated Primary Completion Date :

Jan 4, 2027

Anticipated Study Completion Date :

Jan 4, 2028

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

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.