- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01830426
Circulating Tumor Cells in Non-Small Cell Lung Carcinoma (LDx)
January 20, 2016 updated by: Epic Sciences
Phase 2 Study of Circulating Tumor Cell in Non-Small Cell Lung Carcinoma
The purpose of this study is to establish the circulating tumor cell (CTC) assay as a surrogate for tissue diagnosis of suspected primary lung cancer.
This is done through evaluating clinical and molecular markers to stratify the outcome/survival in patients with thoracic malignancies treated at Yale University/Yale-New Haven Hospital, University of California San Diego/Moores Cancer Center, Billings Clinic Cancer Center.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
232
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Jolla, California, United States, 92093
- Moores Cancer Center
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Connecticut
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New haven, Connecticut, United States, 06510
- Yale University
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Montana
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Billings, Montana, United States, 59101
- Billings Clinic Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A primary lung cancer bearing population will be studied.
Eligible patients will include those presenting to the specified clinical centers with a tissue confirmed primary lung cancer or radiographic abnormality deemed highly suspicious for primary lung cancer by collaborating clinical team, in whom definitive tissue diagnosis is planned.
All stages of primary lung cancer will considered.
Description
Inclusion Criteria:
- Suspected lung cancer
- Planned to undergo tissue biopsy. Tissue biopsy does not need to be limited to an intrathoracic structures. Biopsies of the supraclavicular lymph nodes are allowed
- Age >18
Exclusion Criteria:
- Patients with history of a separate (not a primary lung cancer) malignancy within past two years.
- Recent history (past two weeks) of trauma (INCLUDING diagnostic surgery, biopsy, etc)
- Prior lung cancer treatment chemotherapy, radiation, surgery, etc. in past two years.
- Inability to provide informed consent.
- Hgb less than 8.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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CTC Enumeration
Time Frame: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
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After informed consent of the patients, a single tube of blood will be drawn and processed according to the standard protocol.
These blood draws will occur upon patient screening or rather the baseline of their treatment, a 6-12 week follow-up, as well as a 12 month follow-up.Furthermore, a biopsy will be taken between baseline and 6-12 week follow-up which will be used upon results of CTC enumeration to illustrate concordance.
Epic Sciences staff is fully blinded to the clinical data of the patients until final analysis.
Patients will be considered CTC positive at a count of greater than 2 CTCs per ml of blood.
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3 months from baseline, an average of 2 weeks post patient tissue biopsy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung Cancer Subtyping
Time Frame: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
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Based on the blood draws from the primary outcome, Epic will utilize the identified CTCs as biopsy material for lung cancer subtyping that distinguishes between adenocarcinoma (ACA), squamous cell carcinoma (SCC) from other types of primary lung cancer.
Lung cancer histology will be evaluated for each patient sample: Two slides will be run with the ACA-CTC assay (TTF1 or Napsin A) and two slides will be run with the SCC-CTC (p63) assay.
For the purpose of assay development and validation, we have all already procured a validated set of patient samples with known histology.
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3 months from baseline, an average of 2 weeks post patient tissue biopsy
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Nodal Staging
Time Frame: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
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For patients ultimately diagnosed with lung cancer and deemed to be surgical candidates, surgical intervention will be performed.
In accordance to a standard practice mediastinal lymph node dissection will accompany the surgery.
Nodal staging for each patient in the trial with diagnosed lung cancer will be evaluated clinically and pathologically.
Clinical staging will be determined by the treating clinician prior to information being available from surgery and recorded in the case report form.
The diagnostic accuracy of the clinical stage will be determined by comparison with the pathological stage which will be abstracted from the pathology report for surgically staged patients.
We will determine the sensitivity and specificity of the CTC count as a test that identifies patients who will ultimately be "upstaged" from N0 to N1 or from N1 to N2-3 at the time of surgical staging when comparing the clinical and pathological stage.
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3 months from baseline, an average of 2 weeks post patient tissue biopsy
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Establish the Prognostic Value by measuring CTC count over time.
Time Frame: Baseline, 3 months, 24 months and 66 months
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This measure will work to establish the prognostic value of the initial test by drawing the correlation with outcome data.
For the 260 patients recruited to this clinical trial, stage specific Kaplan-Meier overall and disease free survival curves for the population will be generated after 2 years of follow-up.
For each stage, the results of the CTCs will then be used to separate the population for each stage into a low CTC and high CTC group to determine if the disease free survival curves for each stage separate on the basis of the assay and are statistically significant using a retrospective analysis of the prospectively collected data, this will determine if knowledge of the CTC assay provides useful information about disease free survival beyond that which is obtained by clinical staging alone.
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Baseline, 3 months, 24 months and 66 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ryan Dittamore, MBA, Epic Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
March 25, 2013
First Submitted That Met QC Criteria
April 11, 2013
First Posted (Estimate)
April 12, 2013
Study Record Updates
Last Update Posted (Estimate)
January 22, 2016
Last Update Submitted That Met QC Criteria
January 20, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HHSN261201200049C
- HHSN26120100049C (Other Grant/Funding Number: National Cancer Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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