NCT05870592

Brief Summary

There are numerous Department of Defense (DoD) beneficiaries enrolled in the various lung cancer screening programs across the DoD. This study may enable patients to forego annual CT lung cancer screening or help to predict cancerous nodules without interventional procedures. This is a prospective observational study of sputum cytology using flow cytometry to analyze sputum samples collected from patients in the active military who are undergoing annual lung cancer screening. The primary objective of this study is to analyze the cellular profiles of sputum samples collected from the Acapella® airway assist device in patients at higher risk for lung cancer. The target population are high risk patients for developing lung cancer, age 50-80 with a significant smoking history.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

May 10, 2023

Last Update Submit

July 9, 2023

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Primary Objective

    The primary objective of this study is to analyze the cellular profiles of sputum samples collected from the Acapella® airway assist device in patients at higher risk for lung cancer.

    12 months

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be identified from the BAMC Pulmonary lung cancer screening tracker. After completion fo their annual LDCT, patients will be asked if they wish to participate in the study and provide a 3-day sputum sample. If they request to participate, they will meet with one of the study investigators to provide written informed consent. Once consented, they will be provided with an Acapella device and instructed on the use for sample collection

You may qualify if:

  • Active Military
  • years-of-age
  • Smoking history of 20-pack-years or more
  • If not currently smoking cigarettes, quit smoking within 15 years of giving sputum sample
  • Undergoing CT scan of chest as part of annual screening for lung cancer

You may not qualify if:

  • Active respiratory illness in the preceding 2 weeks
  • Using antibiotics in the past 2 weeks
  • Unable to use Acapella device for sputum collection
  • Known history of lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Hospital

San Antonio, Texas, 78234, United States

Location

Related Publications (5)

  • Grayson M, Lai SC, Bederka LH, Araujo P, Sanchez J, Reveles XT, Rebel VI, Rebeles J. Quality-Controlled Sputum Analysis by Flow Cytometry. J Vis Exp. 2021 Aug 9;(174). doi: 10.3791/62785.

    PMID: 34424239BACKGROUND

  • Bederka LH, Sanchez JR, Rebeles J, Araujo PR, Grayson MH, Lai SC, DePalo LR, Habib SA, Hill DG, Lopez K, Patriquin L, Sussman R, Humphreys J, Reveles XT, Rebel VI. Sputum analysis by flow cytometry; an effective platform to analyze the lung environment. PLoS One. 2022 Aug 17;17(8):e0272069. doi: 10.1371/journal.pone.0272069. eCollection 2022.

    PMID: 35976857BACKGROUND

  • Elzi DJ, Bauta WE, Sanchez JR, Das T, Mogare S, Zannes Fatland P, Iza M, Pertsemlidis A, Rebel VI. Identification of a novel mechanism for meso-tetra (4-carboxyphenyl) porphyrin (TCPP) uptake in cancer cells. FASEB J. 2021 Mar;35(3):e21427. doi: 10.1096/fj.202000197R.

    PMID: 33629776BACKGROUND

  • Lemieux ME, Reveles XT, Rebeles J, Bederka LH, Araujo PR, Sanchez JR, Grayson M, Lai SC, DePalo LR, Habib SA, Hill DG, Lopez K, Patriquin L, Sussman R, Joyce RP, Rebel VI. Detection of early-stage lung cancer in sputum using automated flow cytometry and machine learning. Respir Res. 2023 Jan 21;24(1):23. doi: 10.1186/s12931-023-02327-3.

    PMID: 36681813RESULT

  • Patriquin L, Merrick DT, Hill D, Holcomb RG, Lemieux ME, Bennett G, Karia B, Rebel VI, Bauer T 2nd. Early Detection of Lung Cancer with Meso Tetra (4-Carboxyphenyl) Porphyrin-Labeled Sputum. J Thorac Oncol. 2015 Sep;10(9):1311-1318. doi: 10.1097/JTO.0000000000000627.

    PMID: 26200451RESULT

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Michael J Morris, MD

    Brooke Army Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Morris, MD

CONTACT

210-916-3027michael.j.morris34.civ@health.mil

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 23, 2023

Study Start

August 1, 2023

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)