Lung EpiCheck Biomarkers Development Study
This study is part of the development of a non-invasive lung cancer screening test which aim to identify early-stage lung cancer in patients at high risk for lung cancer.
Studieöversikt
Detaljerad beskrivning
This is a prospective, multi-center, observational nonsignificant risk study aimed to collect blood and clinical data from primary lung cancer and control subjects to characterize various biomarkers that will discriminate between lung cancer and control subjects.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Florida
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Miami, Florida, Förenta staterna, 33130
- Life Spring Clinical Research
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Panama City, Florida, Förenta staterna, 32405
- Emerald Coast OBGYN
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Louisiana
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Shreveport, Louisiana, Förenta staterna, 71106
- Ochsner LSU Health Shreveport - Regional Urology
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Michigan
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Southfield, Michigan, Förenta staterna, 48076
- Comprehensive Urology
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Troy, Michigan, Förenta staterna, 48084
- Michigan Institute of Urology, P.C.
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Texas
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San Antonio, Texas, Förenta staterna, 78229
- Urology San Antonio
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Haifa, Israel
- Carmel Medical Center
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Tel Aviv, Israel
- Sourasky Medical Center
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Hengelo, Nederländerna
- ZGT Medical Center
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Budapest, Ungern
- National Koranyi Institute for Pulmonology
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
All subjects should be without other cancer in the past 5 years except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
Beskrivning
Inclusion Criteria - Cases:
- Age 50-80 years
- Subjects who are currently smoking or former smokers, with at least 20 pack-years
- Subjects with either A high suspicion for lung cancer, with planned biopsy or surgery to establish a definitive diagnosis within 60 days after enrollment or treatment naive lung cancer patients confirmed by pathology.
Exclusion Criteria - Cases
- Known diagnosis or treatment of cancer from any kind in the past 5 years, except of fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix and except from the current lung cancer
Inclusion Criteria - USPSTF risk
- Age 50-80 years
- Subjects who are currently smoking or former smokers, with at least 20 pack-years
Exclusion Criteria - USPSTF risk
- Known diagnosis or treatment of cancer of any kind in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
Inclusion Criteria - Healthy controls
- Age 20-80 years
- Never smoker or current / previous smoker < 20 pack year history
Exclusion Criteria - Healthy Controls
- Known diagnosis or treatment of cancer of any kind in the past (lifetime), except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix.
- Not previously diagnosed with a lung lesion highly suspicious for cancer
- Under follow up or work up for any lesion suspicious for any type of cancer
- Presenting with fever with body temperature 100.4°F (38°C) or higher
- Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw
- Pregnancy
- Any history of blood product transfusion within 30 days prior to blood draw
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Cases Cohort
Subjects age 50-80 years old, with smoking history of at least 20 pack years with either (a) a high suspicion for lung cancer, who are planned to undergo biopsy or surgery to establish a definitive diagnosis after enrollment; or (b) confirmed primary lung cancer diagnosis, treatment naïve subjects. |
Blood collection |
|
USPSTF At Risk - Control Cohort
Healthy subjects aged 50-80 years old with smoking history of at least 20 pack years. |
Blood collection |
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Healthy Control Cohort
Healthy subjects aged 20-80 years old which are non-smokers or with smoking history of less than 20 pack years. |
Blood collection |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Performance
Tidsram: Day 1
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Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value). |
Day 1
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Evergreen-LNG-001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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