Circulating Tumor Cells in Non-Small Cell Lung Carcinoma

NCT ID: NCT01830426

Last Updated: 2016-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

232 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

Billings Clinic

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Epic Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan Dittamore, MBA

Role: PRINCIPAL_INVESTIGATOR

Epic Sciences

Locations

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Moores Cancer Center

La Jolla, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status

Countries

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United States

Other Identifiers

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HHSN26120100049C

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HHSN261201200049C

Identifier Type: -

Identifier Source: org_study_id

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