Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network

NCT01574300 | Terminated

• 2 other identifiers: VICC THO 09110CASTLE Study
• Study Type: observational
• Target: 136
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer Metastatic; Small Cell Lung Carcinoma

Keywords

Small Cell Lung Cancer (SCLC); Non-Small Cell Lung Cancer (NSCLC); M1A or B NSCLC

Outcome Measures

Primary Outcomes (1)

• Collect, process, store, and distribute for peer-reviewed research studies tumor-related and normal biospecimens from advanced stage lung cancer patients

  7 years

Secondary Outcomes (3)

• Maintain a centralized, computerized database of all specimens

  7 years

• Facilitate integration of molecular assays and other laboratory studies with clinical patient outcomes

  7 years

• Enable the discovery of novel genes and proteins related to cancer and its therapies

  7 years

Study Arms (1)

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: * tumor: epidermal growth factor receptor (EGFR), KRAS (Kirsten RAt Sarcoma) gene and EML4-ALK (echinoderm microtubule-associated protein-like 4 - anaplastic lymphoma kinase) translocations, and EGFR, TS (thymidylate synthase), ERCC1 (excision repair cross-complementing 1) and RRM1 (Ribonucleotide Reductase, M1 Subunit) gene expressions * serum: proteomics predictive for EGFR-TKI (tyrosine kinase inhibotors)response

Other: therapeutic interventions

Interventions

therapeutic interventions OTHER

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

Biospecimens and biofluids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced stage lung cancer patients

You may qualify if:

• 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:
• 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)).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Addario Lung Cancer Medical Institute: lead

Related Links

• Addario Lung Cancer Medical Institute - CASTLE

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

Coal Tar

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tars; Complex Mixtures

Study Design

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

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 10, 2012
• Study Start: November 1, 2010
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: January 10, 2020

Record last verified: 2020-01