Identification of a Plasma Proteomic Signature for Lung Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01752101

Enrollment

475

Registered

2012-12-19

Start date

2012-10-31

Completion date

2014-12-31

Last updated

2015-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Precancerous Conditions

Keywords

Precancerous Conditions, Carcinoma

Brief summary

The primary objective is to identify a panel of plasma and/or serum proteins that differentiates the absence or presence of lung malignancy in samples obtained from subjects enrolled in this IRB/EC approved study with pulmonary nodules.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence rate of Non-Small Cell Lung Cancer	24 months after enrollment	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.

Secondary

Measure	Time frame	Description
Panel of proteins	At the end of the study	The positive and negative predictive value of the test to differentiate between malignancy and inflammatory diseases such as granulomatous disorders.

Countries

United States

Outcome results