A Prospective Longitudinal Collection of Subjects Diagnosed With Small Cell Lung Cancer

March 4, 2015 updated by: Fujirebio Diagnostics, Inc.

A Prospective Longitudinal Collection of Subjects Diagnosed With Small Cell

The purpose of this study is to collect samples to evaluate the ProGRP and NSE assays independently as aids for monitoring the course of disease and therapy in subjects diagnosed with SCLC.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Eastpointe, Michigan, United States, 48021
        • Kelly Family Medical Center, PC
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • St.Louis Cancer Care, LLP
      • St. Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • St. Louis, Missouri, United States, 63136
        • Hematology Oncology Consultants, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Small cell lung cancer patients undergoing treatment.

Description

Inclusion Criteria:

  • Age ≥ 18
  • Confirmed diagnosis of SCLC or mixed SCLC/non-SCLC per histopathology results
  • Scheduled to undergo first-, second- or third-line treatment for SCLC, including chemotherapy, chemotherapy + radiation therapy, or combined concurrent chemoradiotherapy.
  • Able to understand and willing to provide Informed Consent

Exclusion Criteria:

  • No diagnosis of SCLC
  • Not scheduled to undergo treatment for the diagnosis of SCLC
  • Unable to provide Informed Consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujirebio Diagnostics, Inc.

Collaborators

Medical Research Networx LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

May 2, 2012

First Submitted That Met QC Criteria

May 3, 2012

First Posted (ESTIMATE)

May 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDI-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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