NCT01580982

Brief Summary

The mechanisms of sensitivity and resistance to oncogene-targeted therapy can be determined from tumor tissue or tumor cell lines derived from available archival samples and/or from standard-of-care re-biopsy upon suspected tumor progression.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress85%
Jan 2012Jan 2029

Study Start

First participant enrolled

January 23, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
15.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2029

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

16 years

First QC Date

April 17, 2012

Last Update Submit

February 13, 2026

Conditions

Keywords

OncogenesLung and Other Thoracic Cancers

Outcome Measures

Primary Outcomes (1)

  • To identify baseline and treatment-related somatic changes in the tumor tissue from patients with lung and other thoracic cancers.

    To be determined upon funding

Secondary Outcomes (1)

  • To estimate the proportion of patients that subsequent therapy is altered based on the information acquired from such biopsies

    To be determined upon funding

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients considered for this study would be undergoing a standard care procedure

You may qualify if:

  • Patients undergoing investigation or treatment for thoracic cancers with oncogene-targeted therapies
  • Aged 18 years or older
  • Either a) have suspected tumor progression or other condition that dictates a standard-of-care palliative, therapeutic, or diagnostic intervention including but not limited to procedures such as bronchoscopic biopsy, computed tomography (CT) or ultra-sound (US)-guided biopsy, thoracentesis, video assisted thoracoscopic (VATS) pleurodesis, lobectomy, adrenalectomy or pleural catheter placement, providing tumor specimen appropriate molecular analysis or b) have previously had biopsy/surgical intervention with tumor tissue at University of Colorado or an outside institution available for medullar analysis.
  • Patients must have the ability to understand and willingness to sign an informed consent document.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue will be acquired from either archival or de novo biopsy material

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Erin Schenk, MD, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

April 17, 2012

First Posted

April 19, 2012

Study Start

January 23, 2012

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 30, 2029

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations