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UNC Pleural Fluid Registry

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05620329
Recruitment Status : Recruiting
First Posted : November 17, 2022
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Description
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Brief Summary:
Research with biospecimens such as blood, tissue, or body fluids can help researchers understand how the human body works. Researchers can make new tests to find diseases, understand how treatments work, or find new ways to treat a disease. The purpose of this study is to collect biospecimens for research from patients with known or suspected lung cancer. The information learned from the biospecimens may be used in future treatments. The purpose of this protocol is to create a pleural fluid registry for use in future studies.

Condition or disease
Lung Cancer Lung Infection Breast Cancer Malignant Pleural Effusion Empyema

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 9999 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 32 Years
Official Title: University of North Carolina Pleural Fluid Registry
Actual Study Start Date : January 24, 2018
Estimated Primary Completion Date : January 24, 2050
Estimated Study Completion Date : January 24, 2050

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Pleural Fluid Registry
Any subject who has pleural fluid buildup from lung cancer, breast cancer, or lung infection


Outcome Measures
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Primary Outcome Measures :
  1. Creation of a pleural fluid registry [ Time Frame: 32 years ]
    Biological specimens and corresponding clinical data from subjects will be collected during standard of care procedures and medical record abstraction to support the creation of a pleural fluid registry.


Biospecimen Retention:   Samples With DNA
Blood and pleural fluid

Eligibility Criteria
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Information from the National Library of Medicine

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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
UNC patients
Criteria

Inclusion Criteria:

  • Patients who are 18 years or older
  • Inpatients and outpatients
  • Diagnosed with pleural fluid, are referred for and undergo clinically indicated drainage who have clinical evidence of:
  • pulmonary infection (such as fever, leukocytosis, new or worsening infiltrate on chest x-ray, or clinical deterioration) with effusion
  • malignancy

Exclusion Criteria:

  • A subject will not be eligible for inclusion in this registry if, in the investigator's (or treating clinician's) opinion, the patient has any concurrent medical condition that may preclude their ability to undergo pleural fluid drainage safely.
  • Incarcerated individuals
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): NCT05620329


Contacts
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Contact: Carmmen Garcia +1 954-336-7499 carmmene@med.unc.edu
Contact: Luz Cuaboy +1 954-336-7499 luz_cuaboy@med.unc.edu

Locations
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United States, North Carolina
UNC Lingeberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Carmmen Garcia    919-966-4432    carmmene@med.unc.edu   
Contact: Luz Cuaboy       luz_cuaboy@med.unc.edu   
Principal Investigator: Jason Akulian, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Jason Akulian UNC Lineberger Comprehensive Cancer Center
More Information
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Additional Information:

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT05620329    
Other Study ID Numbers: LCCC1754
First Posted: November 17, 2022    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD with other researchers.

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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 UNC Lineberger Comprehensive Cancer Center:
biospecimen
pleural fluid
lung cancer
 cancer
infection
breast cancer
Additional relevant MeSH terms:
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Empyema
Pleural Effusion, Malignant
Pleural Effusion
Neoplasms by Site
Neoplasms
Infections
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Respiratory Tract Diseases
Pleural Diseases
Pleural Neoplasms
Suppuration
Inflammation
Pathologic Processes