Identification of a Plasma Proteomic Signature for Lung Cancer
This study is currently recruiting participants.
Verified February 2013 by Integrated Diagnostics
Sponsor:
Integrated Diagnostics
Information provided by (Responsible Party):
Integrated Diagnostics
ClinicalTrials.gov Identifier:
NCT01752101
First received: November 30, 2012
Last updated: February 19, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Precancerous Conditions Carcinoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Identification of a Plasma Proteomic Signature for Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Integrated Diagnostics:
Primary Outcome Measures:
- Incidence rate of Non-Small Cell Lung Cancer [ Time Frame: 24 months after enrollment ] [ Designated as safety issue: No ]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 Outcome Measures:
- Panel of proteins [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]The positive and negative predictive value of the test to differentiate between malignancy and inflammatory diseases such as granulomatous disorders.
Biospecimen Retention: Samples Without DNA
Blood samples
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Patients undergoing procedure for histologic diagnosis of lung nodule(s)
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752101
Contacts
| Contact: Ken Fang, MD | 206-576-6309 | kfang@integrated-diagnostics.com |
Locations
| United States, California | |
| Kaiser Permanente Northern California | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Quyen Chau 415-833-3480 | |
| Principal Investigator: Mark Lin, MD | |
| United States, Maryland | |
| Greater Baltimore Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21204 | |
| Contact: Troy Gogoll 443-849-3123 tgogoll@gbmc.org | |
| Principal Investigator: Neri Cohen, MD | |
| United States, Michigan | |
| Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Dusty Kah 313-916-1074 dkah1@hfhs.org | |
| Principal Investigator: Zane Hammoud, MD | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55901 | |
| Contact: Mary Karaus 507-538-8472 karats.mary@mayo.edu | |
| Principal Investigator: David Midthun, MD | |
| United States, Pennsylvania | |
| Geisinger Medical Center | Recruiting |
| Danville, Pennsylvania, United States, 17822 | |
| Contact: Duane Shaffer 570-271-6866 dlshaffer@geisinger.edu, | |
| Principal Investigator: Michael Ayers, MD | |
| United States, Washington | |
| Group Health Research Institute | Recruiting |
| Seattle, Washington, United States, 98101 | |
| Contact: Kelly Hansen 206-287-2453 hansen.ke@ghc.org | |
| Principal Investigator: Jeff Sullivan, MD | |
Sponsors and Collaborators
Integrated Diagnostics
Investigators
| Study Director: | Ken Fang, MD | Integrated Diagnostics, Inc. |
More Information
No publications provided
| Responsible Party: | Integrated Diagnostics |
| ClinicalTrials.gov Identifier: | NCT01752101 History of Changes |
| Other Study ID Numbers: | 1013-12 |
| Study First Received: | November 30, 2012 |
| Last Updated: | February 19, 2013 |
| Health Authority: | United States: Quorum Review IRB |
Keywords provided by Integrated Diagnostics:
|
Precancerous Conditions Carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Lung Neoplasms Precancerous Conditions Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013