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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01591512
Other study ID # FDI-36
Secondary ID
Status Terminated
Phase N/A
First received May 2, 2012
Last updated March 4, 2015
Start date May 2011
Est. completion date July 2012

Study information

Verified date March 2015
Source Fujirebio Diagnostics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States St.Louis Cancer Care, LLP Bridgeton Missouri
United States Kelly Family Medical Center, PC Eastpointe Michigan
United States Heartland Regional Medical Center St. Joseph Missouri
United States Hematology Oncology Consultants, Inc. St. Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Fujirebio Diagnostics, Inc. Medical Research Networx LLC

Country where clinical trial is conducted

United States, 

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