Collection of Malignant Ascites, Pleural Fluid, and Blood From People With Solid Tumors
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03189108 |
Recruitment Status :
Enrolling by invitation
First Posted : June 16, 2017
Last Update Posted : May 26, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
---|
Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer Cancer |
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 Type : | Observational |
Estimated 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 |
Estimated Primary Completion Date : | January 4, 2027 |
Estimated Study Completion Date : | January 4, 2028 |

Group/Cohort |
---|
Cohort 1
Patients with a diagnosis of malignant solid tumor
|
- 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 ]Experimental - Translational study outcomes from the collection/analysis of blood samples; and ascites and pleural effusion samples from patients with solid tumor malignancies.
- 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 tumor cells and peripheral blood leukocytes from the same patient in xenograft models [ Time Frame: ongoing ]
- Establish a bank of clinically annotated samples for translational science. [ Time Frame: ongoing ]
- Compare selected matched sets of samples from the same patient to evaluate both for treatment response. [ Time Frame: ongoing ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
- 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.

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
United States, Maryland | |
National Institutes of Health Clinical Center | |
Bethesda, Maryland, United States, 20892 |
Principal Investigator: | Christina M Annunziata, M.D. | National Cancer Institute (NCI) |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT03189108 |
Other Study ID Numbers: |
170100 17-C-0100 |
First Posted: | June 16, 2017 Key Record Dates |
Last Update Posted: | May 26, 2022 |
Last Verified: | December 21, 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | .All IPD recorded in the medical record will be shared with intramural investigators upon request. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | Clinical data available during the study and indefinitely. |
Access Criteria: | Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Malignant Effusion Composition Paracentesis Thoracentesis Natural History |
Fallopian Tube Neoplasms Ascites Neoplasms by Site Neoplasms Adnexal Diseases |
Genital Neoplasms, Female Urogenital Neoplasms Fallopian Tube Diseases Pathologic Processes |