Lung Cancer Mutation Consortium Protocol
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Purpose
The primary objective of this protocol is to determine the frequency of oncogenic mutations in 1000 patients with advanced adenocarcinoma of the lung. The linked clinical and mutational analyses will be used to determine the frequency of each mutation, its association with clinical features and outcome, and its association with other mutations. As future therapeutic protocols specific for these mutations are developed, patients may be notified of their eligibility for these studies. Future translational studies may be used to: a) unravel the complex biology of lung cancer; b) identify prognostic markers; c) define predictive markers of response/resistance to new therapies; d) identify new targets. A secondary goal is to establish a consortium of sites that have the capability of conducting multiple mutation testing in a CLIA-certified lab.
| Condition | Intervention |
|---|---|
|
Stage IIIB/IV Adenocarcinoma |
Other: No intervention |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | Lung Cancer Mutation Consortium Protocol |
- The primary objective of this protocol is to determine the frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung. The primary endpoint of this protocol is the mutation rate. [ Time Frame: Five years ] [ Designated as safety issue: No ]
- The secondary objectives of this protocol are to study the associations between each mutation and clinical outcomes, e.g., survival, clinical features, e.g. smoking status, age, and other mutation. [ Time Frame: Two years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Biopsy remnant tissue
| Estimated Enrollment: | 1000 |
| Study Start Date: | September 2009 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Advanced Adenocarcinoma
Stage IIIB/IV adenocarcinoma who have undergone biopsy with remnant tissue.
|
Other: No intervention
No study intervention for this trial
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Stage IIIB/IV adenocarcinoma of the lung who have undergone biopsy with remnant tissue.
Inclusion Criteria:
- Subjects (=> 18 years of age) who are undergoing further evaluation for the diagnosis or treatment of advanced adenocarcinoma of the lung.
- Oral and written informed consent.
Exclusion Criteria:
- Any individual who does not give oral and written consent for participation.
- Lung cancer histologies other than adenocarcinoma
- Lack of adequate tissue.
Contacts and Locations| Contact: Kelly Kugler, B.S. | 303-724-4168 | kelly.kugler@ucdenver.edu |
| Contact: Mary Jackson | 303-724-1650 | mary.k.jackson@ucdenver.edu |
| United States, Colorado | |
| University of Colorado Denver Cancer Center | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Kelly Kugler, B.S. 303-724-4168 kelly.kugler@ucdenver.edu | |
| Contact: Mary Jackson 303-724-1650 mary.k.jackson@ucdenver.edu | |
| Principal Investigator: Wilbur Franklin, M.D. | |
| Principal Investigator: | Wilbur Franklin, M.D. | University of Colorado, Denver |
| Study Director: | Paul Bunn, M.D. | University of Colorado, Denver |
More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01014286 History of Changes |
| Other Study ID Numbers: | 09-0756 |
| Study First Received: | November 12, 2009 |
| Last Updated: | November 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Lung Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013