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Identification of a Plasma Proteomic Signature for Lung Cancer


N/A
40 Years
N/A
Open (Enrolling)
Both
Precancerous Conditions, Carcinoma

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Trial Information

Identification of a Plasma Proteomic Signature for Lung Cancer


Blood samples are obtained from those patients undergoing procedures to determine if a lung
nodule is benign or cancerous. The data from the study will not be used to guide or
influence the treatment of the patients enrolled in this study. There is no change from the
normal standard of care that patients receive.


Inclusion Criteria:



- age ≥ 40

- any smoking status, e.g. current, former, or never

- co-morbid conditions, e.g. COPD

- Nodule size ≥ 4 mm and ≤ 30 mm (up to Stage 2B eligible), any spiculation or ground
glass opacity

- Pathology: malignant - adenocarcinoma, squamous, or large cell

- Pathology: benign - inflammatory (e.g. granulomatous, infectious) or non-inflammatory
(e.g. hamartoma)

- Clinical stage, Primary tumor: ≤T2 (e.g. 1A, 1B, 2A and 2B)

- Clinical stage, Regional lymph nodes: N0 or N1 only

- Clinical stage, Distant metastasis: M0 only

Exclusion Criteria:

- prior malignancy within 5 years of lung nodule diagnosis

- No nodule size available

- No pathology data available for those with

- Current diagnosis of non-small cell lung cancer

- Clinical stage: Primary tumor ≥T3; Regional lymph nodes: ≥N2; 4 Distant metastasis:
≥M1

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Incidence rate of Non-Small Cell Lung Cancer

Outcome Description:

The incidence rate of non-small cell lung cancer in the study population will be correlated to the predictive value of the Sponsor's blood test.

Outcome Time Frame:

24 months after enrollment

Safety Issue:

No

Principal Investigator

Ken Fang, MD

Investigator Role:

Study Director

Investigator Affiliation:

Integrated Diagnostics, Inc.

Authority:

United States: Quorum Review IRB

Study ID:

1013-12

NCT ID:

NCT01752101

Start Date:

October 2012

Completion Date:

August 2013

Related Keywords:

  • Precancerous Conditions
  • Carcinoma
  • Precancerous Conditions
  • Carcinoma
  • Carcinoma
  • Lung Neoplasms
  • Precancerous Conditions

Name

Location

Mayo ClinicRochester, Minnesota  55905
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Henry Ford HospitalDetroit, Michigan  48202
Greater Baltimore Medical CenterBaltimore, Maryland  21204
University of CincinnatiCincinnati, Ohio  45267-0502
Group Health Research InstituteSeattle, Washington  98101
Kaiser Permanente Northern CaliforniaOakland, California  94612
Intermountain HealthcareSalt Lake City, Utah  84103
North East Alabama Regional Medical CenterAnniston, Georgia  36207
Lahey Hospital & Medical CenterBurlington, Massachusetts  01805
Cardiopulmonary Research Science and Technology InstituteDallas, Texas  75230