Identification of a Plasma Proteomic Signature for Lung Cancer

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 12-004940
    • Rochester, Minnesota: 12-004940
    NCT ID: NCT01752101
    Sponsor Protocol Number: 1013-11/12

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

David Midthun, M.D.

Closed for enrollment

Rochester, Minn.

Mayo Clinic principal investigator

David Midthun, M.D.

Closed for enrollment

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CLS-20151033

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