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

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ClinicalTrials.gov Identifier: NCT03189108

Recruitment Status : Recruiting

First Posted : June 16, 2017

Last Update Posted : July 20, 2018

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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
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
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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Ovarian cancer

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer Fallopian Tube Cancer

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Cohort 1 Patients with a diagnosis of malignant solid tumors

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 [ 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.

Secondary Outcome Measures :

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 sets of samples from the same patient to evaluate both for treatment response [ Time Frame: ongoing ]
Establish a bank of clinically annotated samples for translational science. [ Time Frame: ongoing ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All adult oncology patients undergoing screening for trials at the NIH/NCI

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).

Contacts and Locations

Information from the National Library of Medicine

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

Contacts


Contact: Irene Ekwede, R.N.	(240) 760-6126	ekwedeib@mail.nih.gov

Locations


United States, Maryland
National Institutes of Health Clinical Center	Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Christina M Annunziata, M.D.	National Cancer Institute (NCI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site


Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT03189108 History of Changes
Other Study ID Numbers:	170100 17-C-0100
First Posted:	June 16, 2017 Key Record Dates
Last Update Posted:	July 20, 2018
Last Verified:	April 28, 2018


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):


Paracentesis Thoracentesis

Additional relevant MeSH terms:


Fallopian Tube Neoplasms Ascites Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site	Neoplasms Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Pathologic Processes

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