NCT05620329

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,999

participants targeted

Target at P75+ for all trials

Timeline
289mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jan 2018Jan 2050

Study Start

First participant enrolled

January 24, 2018

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
27.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2050

Last Updated

October 16, 2025

Status Verified

October 1, 2025

Enrollment Period

32 years

First QC Date

November 9, 2022

Last Update Submit

October 15, 2025

Conditions

Keywords

biospecimenpleural fluidlung cancercancerinfectionbreast cancer

Outcome Measures

Primary Outcomes (1)

  • Creation of a pleural fluid registry

    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.

    32 years

Study Arms (1)

Pleural Fluid Registry

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

UNC patients

You may qualify if:

  • 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

You may not qualify if:

  • Incarcerated individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Lingeberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood and pleural fluid

MeSH Terms

Conditions

Lung NeoplasmsBreast NeoplasmsPleural Effusion, MalignantEmpyemaNeoplasmsInfections

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPleural NeoplasmsPleural EffusionPleural DiseasesSuppurationInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jason Akulian

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
32 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 17, 2022

Study Start

January 24, 2018

Primary Completion (Estimated)

January 24, 2050

Study Completion (Estimated)

January 24, 2050

Last Updated

October 16, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD with other researchers.

Locations