NCT00316134

Brief Summary

The purpose of this clinical trial is to evaluate the ability of various biomarkers measured in serum and/or pleural fluids to estimate the risk of finding cancer in patients with undiagnosed pleural effusions. An algorithm for prediction of the risk of finding cancer in the patient using an optimal combination of markers will be developed, and patients will be categorized as having a low, moderate, or high risk of finding cancer that might be used to more effectively triage patients.

Trial Health

57
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Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
terminated

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 Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

First QC Date

April 18, 2006

Last Update Submit

November 7, 2011

Conditions

Keywords

Pleural DiseasesPleural EffusionPleural Effusion, MalignantPleural NeoplasmsNeoplasms, Pleural

Study Arms (1)

Pts scheduled to remove pleural fluid

Procedure: Procedure/Surgery

Interventions

Diagnostic and/or therapeutic procedure to remove pleural fluid.

Pts scheduled to remove pleural fluid

Eligibility Criteria

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

N/A - study was closed

You may qualify if:

  • Subjects able to understand and sign Informed Consent;
  • Males or females \>18 years of age;
  • Have a pleural effusion of known or unknown origin;
  • Scheduled for a diagnostic and/or therapeutic procedure to remove pleural fluid.
  • Subjects able to understand and sign Informed Consent;
  • Males or females \>18 years of age;
  • Have a pleural effusion of unknown origin;
  • Scheduled for a diagnostic procedure to remove pleural fluid.

You may not qualify if:

  • For Subjects currently receiving chemotherapy and/or radiation therapy- Subjects who have received chemotherapy and/or radiation therapy must have completed these modalities one month before entering the study.
  • Females known to be pregnant;
  • Already entered into the study;
  • Unable or unwilling to provide informed consent or is there a high risk that the subject may not comply with the protocol requirements
  • For Subjects currently receiving chemotherapy and/or radiation therapy- Subjects who have received chemotherapy and/or radiation therapy must have completed these modalities one month before entering the study.
  • Females known to be pregnant;
  • Already entered into the study;
  • Unable or unwilling to provide informed consent or is there a high risk that the subject may not comply with the protocol requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujirebio Diagnostics, Inc

Malvern, Pennsylvania, 19355, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and pleural fluids

MeSH Terms

Conditions

Pleural EffusionPleural Effusion, MalignantPleural DiseasesPleural Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Jeffrey Allard, PhD

    Fujirebio Diagnostics, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 20, 2006

Study Start

March 1, 2006

Study Completion

February 1, 2008

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations