NCT01415739

Brief Summary

This research studies protein in tumor samples from patients with non-small cell lung cancer. Finding specific proteins in tumor tissue samples from patients with cancer may help doctors tell what type of lung cancer a patient has and plan better treatment.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

August 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

3.8 years

First QC Date

August 11, 2011

Last Update Submit

January 22, 2019

Conditions

Lung Cancer

Keywords

stage IA non-small cell lung cancerstage IB non-small cell lung canceradenocarcinoma of the lungsquamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Validation of a novel 4-protein signature's ability to subtype NSCLC

    1 month

Secondary Outcomes (1)

  • NSCLC misclassification rate

    1 month

Study Arms (1)

Novel Molecular NSCLC Classification (H & E staining, IHC)

Previously collected tissue samples are analyzed via H\&E staining and IHC.

Other: laboratory biomarker analysis

Interventions

laboratory biomarker analysisOTHER

Correlative studies

Novel Molecular NSCLC Classification (H & E staining, IHC)

Eligibility Criteria

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

Patients with non-small cell lung cancer registered on CALGB 9761

You may qualify if:

  • Patients must have been registered on CALGB-9761
  • Stage I disease
  • Treatment-naive patients
  • A representative paraffin block of the primary tumor must be available from patients on CALGB-9761 and submitted to the CALGB Pathology Coordinating Office
  • A separate consent form is not required for this study, as permission for research to be performed on the tissue blocks is included in the consent form for CALGB 9761
  • Institutional review board (IRB) review and approval at the institution where the laboratory work will be performed is required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alliance for Clinical Trials in Oncology

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Daniel J. Boffa, MD

    Smilow Cancer Hospital at Yale-New Haven

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2011

First Posted

August 12, 2011

Study Start

October 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 24, 2019

Record last verified: 2019-01

Locations

US(1)