NCT01591512

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Geographic Reach
1 country

4 active sites

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

May 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

May 2, 2012

Last Update Submit

March 4, 2015

Conditions

Keywords

Small Cell Lung CancerSCLCLung CancerSubjects diagnosed with SCLC who will undergo treatment

Eligibility Criteria

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

Small cell lung cancer patients undergoing treatment.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kelly Family Medical Center, PC

Eastpointe, Michigan, 48021, United States

Location

St.Louis Cancer Care, LLP

Bridgeton, Missouri, 63044, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

Hematology Oncology Consultants, Inc.

St Louis, Missouri, 63136, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collection of whole blood and urine.

MeSH Terms

Conditions

Small Cell Lung CarcinomaLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

May 2, 2012

First Posted

May 4, 2012

Study Start

May 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations