CompletedNot applicableNCT01785342

DECAMP-1: Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

The goal is to improve the efficiency of the diagnostic follow-up of patients with indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis that are measured in minimally invasive biospecimens are able to distinguish malignant from benign pulmonary nodules that are incidentally detected in high-risk smokers.

Checked against the public recordLast updated Mar 15, 2022 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations15
SponsorBoston University
01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Boston University
Interventions being studied
Other: Biosample and Imaging Collection
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * 45 years of age or older; * Initial diagnosis of indeterminate pulmonary nodule (0.7-3.0 cm); * Smoking status: Current or former smoker with ≥ 20 pack years (pack years = number of packs per day X number of years smoked) * Willing to undergo fiberoptic bronchoscopy; * Able to tolerate all biospecimen collection as required by protocol; * Able to comply with standard of care follow up visits including clinical exams, diagnostic work-ups, and imaging for a minimum of two years; * Able to fill out Patient Lung History questionnaire; * Willing and able to provide a written informed consent. Exclusion Criteria: * History or previous diagnosis of lung cancer; * Diagnosis of pure ground glass opacities on chest CT; * Contraindications to nasal brushing or fiberoptic bronchoscopy including ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease, unstable cardiac or pulmonary disease; inability to protect airway or altered level of consciousness; * Allergies to any local anesthetic that may be used to obtain biosamples in the study.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Regents of the University of California LA (Los Angeles VA Healthcare System)Los Angeles, California
  • University of California Los Angeles Medical CenterLos Angeles, California
  • Naval Medical Center San DiegoSan Diego, California
  • Denver Research InstituteDenver, Colorado
  • Walter Reed National Military Medical CenterBethesda, Maryland
  • Boston University Medical CenterBoston, Massachusetts
  • Boston VA Research Institute, IncBoston, Massachusetts
  • Health Research Inc. Roswell Park DivisionBuffalo, New York
  • Trustees of University of Pennsylvania (Philadelphia VA Medical Center)Philadelphia, Pennsylvania
  • University of PennsylvaniaPhiladelphia, Pennsylvania
  • Veterans Research Foundation of PittsburghPittsburgh, Pennsylvania
  • Middle Tennessee Research Institute (Vanderbilt University)Nashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 15, 2022. Always confirm current availability with the study team.

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