Circulating Tumor Cells in Non-Small Cell Lung Carcinoma

NCT01830426 | Completed DMC

• 2 other identifiers: HHSN261201200049CHHSN26120100049C
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Primary Lung Cancer

Outcome Measures

Primary Outcomes (1)

• CTC Enumeration

  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.

  3 months from baseline, an average of 2 weeks post patient tissue biopsy

Secondary Outcomes (3)

• Lung Cancer Subtyping

  3 months from baseline, an average of 2 weeks post patient tissue biopsy

• Nodal Staging

  3 months from baseline, an average of 2 weeks post patient tissue biopsy

• Establish the Prognostic Value by measuring CTC count over time.

  Baseline, 3 months, 24 months and 66 months

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Epic Sciences: lead
• Yale University: collaborator
• Billings Clinic: collaborator
• University of California, San Diego: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Moores Cancer Center

La Jolla, California, 92093, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cell solution plated onto slides and frozen for storage

Study Officials

• Ryan Dittamore, MBA

  Epic Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 12, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 22, 2016

Record last verified: 2016-01

Locations

US (3)