UNC Pleural Fluid Registry

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05620329

Collaborator

(none)

9,999

Enrollment

Location

384

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Lung Cancer Lung Infection Breast Cancer Malignant Pleural Effusion Empyema

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

9999 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

University of North Carolina Pleural Fluid Registry

Actual Study Start Date :

Jan 24, 2018

Anticipated Primary Completion Date :

Jan 24, 2050

Anticipated Study Completion Date :

Jan 24, 2050

Arms and Interventions

Arm	Intervention/Treatment
Pleural Fluid Registry Any subject who has pleural fluid buildup from lung cancer, breast cancer, or lung infection

Outcome Measures

Primary Outcome Measures

Creation of a pleural fluid registry [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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