Diagnostisk prestanda för litet RNA-blodtest hos patienter som genomgår uppföljningsavbildning efter positiv lågdos CT-screening för lungcancer
Diagnostisk prestanda för små RNA-blodtest hos patienter som genomgår uppföljningsavbildning efter positiv lågdos-CT-screening för lungcancer "Tidig upptäckt av lungcancer baserat på små RNA-signaturer - Boston II"
2,000 individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT screening study and who are scheduled for follow-up diagnostic imaging study, biopsy, clinical consultation or surgical appointment at one of the participating hospitals.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer.
Study duration: Expected patient enrollment to be completed within 12 months after study initiation. Patients will be followed for a minimum of 12 months from the date of enrollment. The study duration is approximately 2 years.
Participant duration: The day of blood collection. Participants will follow their regular standard of care schedule as recommended by existing guidelines; no extra visits are planned. Follow up data will be obtained from the electronic medical record within at least 12 months of follow-up period.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30342
- Northside Hospital
-
-
Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70808
- Our Lady of the Lake Regional Medical Center
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-
Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Mass General Hospital
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Boston, Massachusetts, Förenta staterna, 02108
- Brigham and Women's Hospital
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Worcester, Massachusetts, Förenta staterna, 01655
- UMass Chan Medical School/UMass Memorial Health
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Michigan
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Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Health
-
-
New York
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Queens, New York, Förenta staterna, 10461
- New York Health + Elmhurst Hospitals
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The Bronx, New York, Förenta staterna, 10461
- Jacobi Medical Center
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Pennsylvania
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DuBois, Pennsylvania, Förenta staterna, 15801
- Clinical Research Associates of Central PA
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Texas
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Beaumont, Texas, Förenta staterna, 77701
- Baptist Hospitals of Southeast Texas
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Utah
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Salt Lake City, Utah, Förenta staterna, 84112
- University Of Utah Health
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT screening study and who are scheduled for follow-up diagnostic imaging study, biopsy, clinical consultation or surgical appointment at one of the participating hospitals.
Beskrivning
Inclusion Criteria:
- Adult male and female patients, aged 50 to 80 years
- Received a lung RADS category 3 or 4 finding on a LDCT screening exam (first or subsequent) and are referred to undergo further diagnostic procedures for the detection of lung cancer
- Has undergone LD-CT screening exam within last 90 days and allows for blood sampling within this period
- Subject may not have undergone any invasive diagnostic procedure in relation to the suspicious nodule
- Able and willing to provide informed consent
Exclusion Criteria:
- Prior history of diagnosed lung cancer
- History of gastrointestinal, hematological, breast, thyroid, and genitourinary cancer within the past 10 years
- Active infectious diseases, such blood borne viral diseases (e.g. AIDS, hepatitis)
- Immunosuppressive medication
- Deemed not able to participate in the study by the investigator
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Participants undergoing diagnostic evaluation following positive LDCT screening
Participants undergoing further diagnostic evaluation following a positive LDCT lung cancer screening result. A blood sample is collected at enrollment, prior to any invasive diagnostic procedure or treatment, for evaluation of a small RNA-based lung cancer assay. Participants are followed to determine the final clinical diagnosis. |
At study enrollment, a blood sample is collected prior to any invasive diagnostic procedure or treatment. A small RNA-based lung cancer assay is performed on the collected blood sample for research purposes. Assay results are not returned to participants or investigators and are not used for clinical decision-making. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Primary Objective
Tidsram: 1 year
|
The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer. The primary endpoint is to detect the presence or absence of lung cancer, as determined by all follow-up imaging, and pathological data obtained throughout the duration of the study. |
1 year
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
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
- Boston II
Plan för individuella deltagardata (IPD)
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Läkemedels- och apparatinformation, studiedokument
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