A Prospective Longitudinal Collection of Subjects Diagnos... | NCT01591512

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

NCT01591512

Sponsor

Fujirebio Diagnostics, Inc.

Status

Terminated

Last Update Posted

Mar 6, 2015Estimated

Enrollment

4Actual

Phase

Not provided

Conditions

Small Cell Lung Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Decision was made by Sponsor to stop the trial.

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

May 2, 2012

First Submission Date that Met QC Criteria

May 3, 2012

First Posted Date

May 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2015

Last Update Posted Date

Mar 6, 2015Estimated

Name	Class
Medical Research Networx LLC	UNKNOWN

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

4Actual

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Small cell lung cancer patients undergoing treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kelly Family Medical Center, PC		Eastpointe	Michigan	48021	United States
St.Louis Cancer Care, LLP

Condition Browse Module

MeSH Terms

ID	Term
D055752	Small Cell Lung Carcinoma
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided