Recruiting

Observational Study

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT05620329

Conditions

Lung Cancer

Lung Infection

Breast Cancer

Malignant Pleural Effusion

Empyema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Lung Cancer

Lung Infection

Breast Cancer

Malignant Pleural Effusion

Empyema

Study ID

NCT05620329

Start date

Jan 24, 2018

Status verified date

Oct, 2025

Completion date

Jan 24, 2050

Anticipated

Primary completion date

Jan 24, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

9999 participants

Anticipated

Interventions and Outcome Measures

Arms

Pleural Fluid Registry

Any subject who has pleural fluid buildup from lung cancer, breast cancer, or lung infection

Primary outcome measure

  • Creation of a pleural fluid registry [ Time Frame: 32 years ]

Central Contacts and Locations

Locations

UNC Lingeberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Jason Akulian, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Oct 16, 2025

Last verified

Oct, 2025

Keywords

  • biospecimen
  • pleural fluid
  • lung cancer
  • cancer
  • infection
  • breast cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2025-10-16.