Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network
This study is currently recruiting participants.
Verified October 2012 by Vanderbilt-Ingram Cancer Center
Sponsor:
Leora Horn, MD
Collaborator:
Addario Lung Cancer Institute (ALCMI)
Information provided by (Responsible Party):
Leora Horn, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01574300
First received: March 28, 2012
Last updated: October 18, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to facilitate application of the known biomarkers to patients presenting today, and to establish a collection of biospecimens that will be useful for discovering and validating new biomarkers for future use.
| Condition | Intervention |
|---|---|
|
Non-small Cell Lung Cancer Metastatic Small Cell Lung Carcinoma |
Other: therapeutic interventions |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network |
Resource links provided by NLM:
Further study details as provided by Vanderbilt-Ingram Cancer Center:
Primary Outcome Measures:
- Collect, process, store, and distribute for peer-reviewed research studies tumor-related and normal biospecimens from advanced stage lung cancer patients [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Maintain a centralized, computerized database of all specimens [ Time Frame: 7 years ] [ Designated as safety issue: No ]Database would contain uniform and complete demographic, pathologic, and clinical information
- Facilitate integration of molecular assays and other laboratory studies with clinical patient outcomes [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- Enable the discovery of novel genes and proteins related to cancer and its therapies [ Time Frame: 7 years ] [ Designated as safety issue: No ]Obtain funding from National Institutes of Health based on use of the biorepository
| Estimated Enrollment: | 250 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Biospecimens and biofluids
This is a multi-cohort parallel study in which tumor, plasma and serum samples will be collected prior to the start of any therapeutic intervention for stage IV lung cancer. These biospecimens will be correlated with treatment and clinical data and distributed for peer reviewed research purposes to academic and community centers in the U.S. and Europe. The biospecimens collected in CASTLE will be analyzed for a panel of biomarkers, currently including:
|
Other: therapeutic interventions
All therapeutic interventions are allowed, and their details recorded and correlated with data from the collected biospecimens. Examples would include single or multiple agent chemotherapy or targeted therapeutics
|
Detailed Description:
Because of the historically poor outcomes of lung cancer patients, suboptimal therapeutic efficacy, and significant side effects of chemotherapy, and the need to choose more efficacious treatment regimens, and patients most likely to benefit from them, there is a need to predict a priori whether an individual patient's tumor will respond to a particular therapeutic agent. However, virtually all lung cancer tumor samples available today are from resection specimens so direct, intra-patient molecular-clinical therapy correlations are impossible.
Without the critical mass of tissue and data necessary to identify optimal molecular targets for lung cancer and drugs active against these targets, new discoveries that offer the only hope of long-term survival for many lung cancer patients remain elusive.
This study facilitates the collection of biospecimens from advanced lung cancer patients and routine determination of a panel of documented clinically significant biomarkers. In addition, it will centrally integrate and standardize research tissue samples with corresponding proteomic, genomic, molecular and clinical data across a multitude of institutions and oncology networks
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Advanced stage lung cancer patients
Criteria
Inclusion Criteria:
- M1A or B NSCLC with any number of prior therapies or any stage Small cell Lung Cancer (SCLC) with any number of prior therapies
- Planned systemic therapy (i.e. intent to treat)
- Provision of written informed consent for biospecimen storage, broad genetic and proteomic analysis of tumor and normal tissues, without restrictions, AND correlation with outcome data
- Aged 18 years and over.
- Measurable or evaluable disease.
- ECOG performance status of 0-2 with expected survival of at least 3 months.
- Tumor specimens:
- Tumor specimens:
- 4.7.1 First Priority: availability of a minimum of a 1 X 10 mm core fresh frozen tumor, or ≥3 mm diameter spherical pellet from a pleural effusion (≥50% tumor cells), or ≥3 mm diameter spherical pellet from a fine needle aspirate (≥50% tumor cells) from clinically indicated interventional procedures, with no systemic anti-cancer therapy or radiation to all sites of evaluable disease between collection of the biopsy and entry into the study (e.g. if a brain metastasis was radiated but the lung tumor was not, then the latter could still be biopsied and the subject enrolled after radiation therapy of the brain metastasis (and vice versa)).
or
- Second Priority: availability of paraffin-embedded tumor (via biopsies or pleural effusions) at least 5 X 5 mm (3 X 3 mm for pleural effusions) cross-sectional tumor area, with no systemic anti-cancer therapy or radiation to all sites of evaluable disease between collection of the biopsy and entry into the study; the collection of the paraffin-embedded tissues may have taken place up to 12 months prior to enrollment in CASTLE.
- Willingness to undergo all study collection procedures and sample analyses including prerequisite baseline molecular testing via ResponseDX: Lung (Response Genetics Inc.) and VeriStrat (Biodesix) - see 6.3 below for details.
- Exclusion criteria
- Other co-existing malignancies except for basal cell carcinoma or cervical cancer in situ.
- Compromise of patient diagnosis or staging if tissue is harvested for research
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574300
Contacts
| Contact: Vanderbilt Cancer Center Clinical Trials Information | 800-811-8480 |
Locations
| United States, California | |
| Alta Bates Summit Medical Center, The Jordan Research and Educational Institute | Recruiting |
| Berkley, California, United States, 94705 | |
| Contact: Margie Macarewich, RN, MSN 510-204-5094 | |
| Principal Investigator: Andrew M Greenberg, MD, PhD | |
| University of California, Norris Comprehensive Cancer Center | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Gina Tse Clinical Investiation Support Office 323-865-0514 | |
| Principal Investigator: Barbara J Gitlitz, MD | |
| University of California, Los Angeles | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Gina Tse Clinical Investigation Support Office 323-865-0514 | |
| Principal Investigator: Barbara Gitlitz, MD | |
| Hoag Memorial Hospital Presbyterian | Recruiting |
| Newport Beach, California, United States, 92658 | |
| Contact: Cheryl Mayorga, LVN, CCRC 949-764-5543 Cheryl.mayorga@hoag.org | |
| Principal Investigator: Doug Zusman, MD | |
| University of California, Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Grace Loredo 916-734-3691 | |
| Contact: Corinne Turrell 916-734-3089 | |
| Principal Investigator: David R. Gandara, MD | |
| University of California, Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Scot Hammond 415-885-3673 | |
| Principal Investigator: Thierry M Jahan, MD | |
| United States, Florida | |
| Memorial Cancer Institute | Recruiting |
| Pembroke Pines, Florida, United States, 33028 | |
| Contact: Norma Cuervo,, RN 954-265-6549 ncuervo@mhs.net | |
| Contact: Paulette Baldie, RN 954-844-9917 pbaldie@mhs.net | |
| Principal Investigator: Luis Raez, MD | |
| United States, Massachusetts | |
| Lahey Clinic Hospital | Recruiting |
| Burlington, Massachusetts, United States, 01805 | |
| Contact: Kathleen Sherman 781-744-5471 | |
| Principal Investigator: Paul Hesketh, MD | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | Active, not recruiting |
| Nashville, Tennessee, United States, 37232 | |
Sponsors and Collaborators
Leora Horn, MD
Addario Lung Cancer Institute (ALCMI)
Investigators
| Principal Investigator: | Leora Horn, MD | Vanderbilt-Ingram Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Leora Horn, MD, Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01574300 History of Changes |
| Other Study ID Numbers: | THO 09110, CASTLE Study |
| Study First Received: | March 28, 2012 |
| Last Updated: | October 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt-Ingram Cancer Center:
|
Small Cell Lung Cancer (SCLC) Non-Small Cell Lung Cancer (NSCLC) M1A or B NSCLC |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Small Cell Lung Carcinoma Neoplasms Neoplasms, Second Primary Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013