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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
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Study Description
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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
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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


Groups and Cohorts
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Group/Cohort
Cohort 1
Patients with a diagnosis of malignant solid tumor


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Develop the malignant fluid as a culture model to replicate intraperitoneal growth of ovarian cancers. [ Time Frame: ongoing ]
  2. Characterize malignant effusion composition through immunohistochemistry and flow cytometry. [ Time Frame: ongoing ]
  3. Compare immune cell phenotype in ascites and blood from the patient. [ Time Frame: ongoing ]
  4. Study in vivo characteristics of matched tumor cells and peripheral blood leukocytes from the same patient in xenograft models [ Time Frame: ongoing ]
  5. Establish a bank of clinically annotated samples for translational science. [ Time Frame: ongoing ]
  6. Compare selected matched sets of samples from the same patient to evaluate both for treatment response. [ Time Frame: ongoing ]

Eligibility Criteria
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Information from the National Library of Medicine

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.


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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
Study Population
Patients who are being seen in follow up, consultation, or presenting for enrollment on a clinical trial at the NIH Clinical Center
Criteria
  • 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.

Contacts and Locations
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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


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Christina M Annunziata, M.D. National Cancer Institute (NCI)
More Information
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Additional Information:

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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.

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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) ):
Malignant Effusion Composition
Paracentesis
Thoracentesis
Natural History
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Ascites
Neoplasms by Site
Neoplasms
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Pathologic Processes