黑料网IN Protocol 4703 | DECAMP-1

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黑料网IN Protocol 4703 | DECAMP-1

Detection of Early lung Cancer Among Military Personnel Study 1 (DECAMP-1): Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

Principal Investigators

Ehab Billatos, MD, and Denise Aberle, MD

Status

Closed to accrual; in follow-up

Limited Site Participation

The Detection of Early lung Cancer Among Military Personnel (DECAMP) consortium is a multidisciplinary and translational research program that includes seven Veterans Administration hospitals (VAH), the four designated Military Treatment Facilities (MTF), and three academic hospitals as clinical study sites, as well as several molecular biomarker laboratories, along with biostatistics, bioinformatics, pathology and biorepository cores.

Overview

The DECAMP-1 trial was developed under the Department of Defense (DoD) and funded through the DoD Lung Cancer Research Program (LCRP), National Cancer Institute (NCI) and Janssen Pharmaceuticals, Inc. In this study, four previously established lung cancer biomarkers will be assessed for future validation.

Main Objective

The main objective of this trial is to improve the efficiency of the diagnostic evaluation of patients with indeterminate pulmonary nodules. The trial will determine the diagnostic accuracy of biomarkers for lung cancer measured in minimally invasive and noninvasive biospecimens, and whether these genomic and proteomic biomarkers in the airway and blood can distinguish between high-risk smokers with malignant or benign indeterminate, incidentally detected pulmonary nodules.

Participants

Patients enrolled will be 45 years or older, have been diagnosed with indeterminate pulmonary nodules within the year prior to enrollment (size at time of consent must be: 0.7 to 3.0 cm), and have a smoking status as a current or former smoker with ≥20 pack years (pack years = number of packs per day x number of years smoked).

Study Design Summary

A total of 500 former or current smokers with a minimum of 20 pack-years of smoking and indeterminate pulmonary nodule(s) on chest CT will be recruited to the trial. Each participant will undergo fiberoptic bronchoscopy, have blood and urine collected, provide sputum and cellular samples, and complete a questionnaire. Imaging studies completed during the trial will be submitted to the 黑料网 Imaging Core Laboratory. Follow-up will comprise standard-of-care practices per institutional norms over two years to allow for diagnosis of indeterminate pulmonary nodules.

Data Forms

Worksheets	Post-Lung Cancer Dx Outcomes Assessment	Data Form Set
A0 – Eligibility and Registration Worksheet PT– Patient Lung Questionnaire Study Evaluation and Diagnosis Worksheet Pre-Test Probability Worksheet Adverse Event (AE) Log	Initial Treatment Worksheet Chemotherapy Worksheet Other Treatment Worksheet Radiation Worksheet Surgery Worksheet Outcomes Assessment Worksheet	Form Set for IRB Submission

Site Memos

Recommendations of the 黑料网 Data Safety Monitoring Board:

DECAMP ECRF source documentation »

Imaging Materials

Imaging manual for sites »

Biospecimen Procedures

Procedure Manual	Transmittal Forms
DECAMP Biospecimen Procedure Manual	Biospecimen Transmittal Bronchial Biopsy – Formalin Fixed Surgical Formalin Fixed Surgical Lung Specimens – Fresh Frozen

Researchers interested in accessing DECAMP biospecimens should submit their responses to the questions in the DECAMP Biospecimen Access Request document to Ehab Billatos, MD, DECAMP Principal Investigator (ebillato@bu.edu).

Education and Recruitment Materials

The 黑料网 makes a variety of tools available to help site personnel with study participant enrollment. If your site would like to use any of the tools listed below, please contact the project specialist assigned to the trial.

Recruitment Manual

Recruitment of participants constitutes a significant portion of the workload associated with the DECAMP studies. Therefore, the DECAMP project at your site will operate more effectively and efficiently if you develop and implement a well-thought-out recruitment plan. The recruitment strategies presented in this manual are intended to serve as a framework as your site develops its individual plan. Download recruitment manual »

Participant Brochure

A DECAMP-1 (黑料网IN 4703) brochure is available for participating sites to assist with participant enrollment. All participant recruitment materials must be approved by the site's IRB prior to distribution. A link to an electronic version for submission to the IRB is provided below. Download DECAMP-1 brochure »

Poster

A DECAMP-1 (黑料网IN 4703) poster is available for display in areas likely to be seen by cardiac patients as well as in general high-traffic areas inside or outside your facility. Download DECAMP -1 poster »

Eligibility Card

Pocket-sized eligibility cards are available for distribution to clinicians who may assist with identifying potential participants. The card does not require IRB approval. Download eligibility card »

Participating Sites

California
VA Greater Los Angeles Health Care System Investigators: Steve Dubinett, MD David Elashoff, PhD Gina Lee, MD Research Associate: Babak Aryanfar Babak.Aryanfar@va.gov Enrollment Status: Open	Naval Medical Center San Diego Investigator: CAPT J. Scott Parrish, MD Research Associate: Divina Fanning divina.v.fanning.ctr@health.mil Enrollment Status: Open
UCLA Medical Center, Los Angeles Investigators: Steve Dubinett, MD David Elashoff, PhD Gina Lee, MD Research Associate: Gregory Ellis GEllis@mednet.ucla.edu Enrollment Status: Open

Colorado
VA Eastern Colorado Health Care System, Denver Investigators: Robert L. Keith, MD Daniel Merrick, MD Research Associate: Brandi Kubala, MA, CCRP 303-724-1657 brandi.kubala@cuanschutz.edu Enrollment Status: Open

Maryland
Walter Reed National Military Medical Center, Bethesda Investigator: Robert Browning, MD Research Associate: Luis E. Rojas 301-295-8713 lrojas@hjfresearch.org Enrollment Status: Open

Massachusetts
VA Boston Healthcare System, Roxbury Investigators: Ron Goldstein, MD Eric Garshik, MD Research Associate: Kathleen Lacerda 857-203-6478 Kathleen.Lacerda@va.gov Enrollment Status: Open	Boston University Medical Center Investigator: Ehab Billatos, MD Research Associate: Denise Fine 617-638-8716 Denise.Fine@bmc.org Enrollment Status: Open

Pennsylvania
Philadelphia VA Medical Center Investigators: Anil Vachani, MD Daniel Sterman, MD Andrew Haas, MD Enrollment Status: Open	VA Pittsburgh Healthcare System Investigator: Charles Atwood, MD Research Associate: Greg Owens 412-360-1527 Gregory.Owens@va.gov Enrollment Status: Open
Hospital of the University of Pennsylvania, Philadelphia Investigators: Anil Vachani, MD Daniel Sterman, MD Andrew Haas, MD Enrollment Status: Open

Tennessee
Nashville VA Medical Center Investigator: Pierre Massion, MD Research Associate: Trey Helton John.Helton2@va.gov Enrollment Status: Open

Virginia
Naval Medical Center Portsmouth Investigator: Evan Butlin, MD Research Associate: N/A Enrollment Status: Closed

DECAMP Study Team Contact Information

黑料网IN 4703 & 4704	Contact	Phone	Email
BU Scientific Program Manager	Maria Perez		perezmt@bu.edu

黑料网 Project Manager	Irene Mahon	215 574-3249	imahon@acr.org

黑料网 Data Management	Jean Ly	215-574-3234	jly@acr.org

黑料网 Image Core Lab	Joe Bauza Sarah Gevo	215 940-8886 215-574-3176	jbauza@acr.org sgevo@acr.org

Regulatory-Monitoring	Chris Steward	215 574-3787	csteward@acr.org

BU Biorepository Manager	Jack Cunningham		jackcunn@bu.edu

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