NCT07012759

Brief Summary

This project aims to assess the expression levels of novel molecular markers identified through screening in clinical samples of malignant pleural effusion, to evaluate the feasibility and clinical utility of these markers as potential diagnostic genes for lung adenocarcinoma.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Jun 2025

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 Progress58%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

June 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 10, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

June 1, 2025

Last Update Submit

March 4, 2026

Conditions

Keywords

Pleural effusionbiomarkerslung cancerclinical diagnosis

Outcome Measures

Primary Outcomes (1)

  • target gene expression levels between malignant and non-malignant pleural effusions

    Novel biomarkers specifically expressed in malignant pleural effusions may provide additional diagnostic options for malignant lung cancer in clinical diagnosis

    20 minutes

Study Arms (2)

Case group

Patients with pleural effusion diagnosed as lung adenocarcinoma.

Other: biomarkers

Control group

Patients with pleural effusion diagnosed as non-malignant.

Other: biomarkers

Interventions

pleural effusion biomarkers in lung adenocarcinoma

Case groupControl group

Eligibility Criteria

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

The control group consists of non-malignant pleural effusion, while the case group includes those diagnosed with pleural effusion with lung adenocarcinoma.

You may qualify if:

  • Patients requiring thoracentesis for pleural effusion drainage as determined by a physician based on clinical need.
  • Signed informed consent.

You may not qualify if:

  • Patients under the age of 18.
  • Patients with malignancies other than lung adenocarcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of LungPleural EffusionLung Neoplasms

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural DiseasesRespiratory Tract DiseasesLung Diseases

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

  • Ke-Yun Chao, PhD

    Fu Jen Catholic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-Yun Chao, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 1, 2025

First Posted

June 10, 2025

Study Start

June 10, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations