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Phase 2 Study of Circulating Tumor Cell in Non-Small Cell Lung Carcinoma


N/A
19 Years
N/A
Open (Enrolling)
Both
Primary Lung Cancer

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Trial Information

Phase 2 Study of Circulating Tumor Cell in Non-Small Cell Lung Carcinoma


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

CTC Enumeration

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

David Nelson, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Epic Sciences

Authority:

United States: Institutional Review Board

Study ID:

HHSN261201200049C

NCT ID:

NCT01830426

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Primary Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplastic Cells, Circulating

Name

Location

Billings Clinic Cancer CenterBillings, Montana  59107-5100
Yale UniversityNew Haven, Connecticut  06520
Moores Cancer CenterLa Jolla, California  92093-0820