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OpenTrials
Completed

NCT Number: NCT01752101

Identification of a Plasma Proteomic Signature for Lung Cancer

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente Northern California, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence rate of Non-Small Cell Lung Cancer

    Time frame: 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 outcomes

  1. Panel of proteins

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Integrated Diagnostics

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 19, 2012
Registry last updated
Jan 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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