Brief Title
Collection of Malignant Ascites, Pleural Fluid, and Blood From People With Solid Tumors
Official Title
Collection of Malignant Ascites, Pleural Fluid, and Blood From Patients With Solid Tumors
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.
Study Type
Observational
Primary Outcome
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.
Secondary Outcome
Develop the malignant fluid as a culture model to replicate intraperitoneal growth of ovarian cancers.
Condition
Ovarian Cancer
Study Arms / Comparison Groups
Cohort 1
Description: Patients with a diagnosis of malignant solid tumors
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
19
Start Date
May 22, 2017
Completion Date
January 4, 2028
Primary Completion Date
January 4, 2027
Eligibility Criteria
- 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).
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Christina M Annunziata, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03189108
Organization ID
170100
Secondary IDs
17-C-0100
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Christina M Annunziata, M.D., Principal Investigator, National Cancer Institute (NCI)
Verification Date
March 18, 2020