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

This study has been terminated.
(Decision was made by Sponsor to stop the trial.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01591512
First Posted: May 4, 2012
Last Update Posted: March 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medical Research Networx LLC
Information provided by (Responsible Party):
Fujirebio Diagnostics, Inc.
  Purpose
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.

Condition
Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Longitudinal Collection of Subjects Diagnosed With Small Cell

Resource links provided by NLM:


Further study details as provided by Fujirebio Diagnostics, Inc.:

Biospecimen Retention:   Samples Without DNA
Collection of whole blood and urine.

Enrollment: 4
Study Start Date: May 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Small cell lung cancer patients undergoing treatment.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591512


Locations
United States, Michigan
Kelly Family Medical Center, PC
Eastpointe, Michigan, United States, 48021
United States, Missouri
St.Louis Cancer Care, LLP
Bridgeton, Missouri, United States, 63044
Heartland Regional Medical Center
St. Joseph, Missouri, United States, 64506
Hematology Oncology Consultants, Inc.
St. Louis, Missouri, United States, 63136
Sponsors and Collaborators
Fujirebio Diagnostics, Inc.
Medical Research Networx LLC
  More Information

Responsible Party: Fujirebio Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT01591512     History of Changes
Other Study ID Numbers: FDI-36
First Submitted: May 2, 2012
First Posted: May 4, 2012
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Fujirebio Diagnostics, Inc.:
Small Cell Lung Cancer
SCLC
Lung Cancer
Subjects diagnosed with SCLC who will undergo treatment

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms