NCT07838519Csak meghívásos
Personalizing Veterans' Lung Cancer Screening and Diagnosis
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 5.
Rövid összefoglaló (regiszter, angolul)
Lung cancer screening with low-dose chest computed tomography (CT) is currently recommended for high-risk individuals who are 50 to 80 years old, have smoked cigarettes for at least 20 pack-years, and currently smoke or quit smoking within the past 15 years. In a prospective cohort at Nashville, Denver, Louisville, Chicago, Kansas City, Salisbury and Seattle Veteran Affairs medical centers, the investigators will evaluate the detection of lung cancer using an expanded screening eligibility criteria based on Veterans' personal and service-related exposures compared to standard of care criteria. Screening a larger population will increase the number of lung nodules needing clinical management and these nodules may or may not be cancer. In a population of Veterans with positive screenings at Nashville, the investigators will also validate a combination biomarker-based approach to manage screen-detected lung nodules to reduce time to lung cancer diagnosis and use of invasive procedures. This study will also convene a Veteran Community Advisory Board and interview Veterans to better understand their thoughts about lung cancer screening and preferences for outreach and engagement.
- Állapot (regiszter)
- Csak meghívásos
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 1400 (tervezett)
- Első benyújtás
- 2026. szept. 9.
- Kezdés
- 2024. ápr. 3.
- Elsődleges befejezés
- 2027. dec. 31.
- Fő szponzor
- VA Office of Research and Development
- Betegségek
- Tüdőrák, Krónikus obstruktív tüdőbetegség (COPD)
- NCT-szám
- NCT07838519
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 1400
- 2024. ápr. 3. és az elsődleges befejezés (2027. dec. 31.) között
- 7 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Más betegség
- Self-reported, family-reported or electronic health record (EHR) diagnosis of dementia via chart review or failure of 3-word recall from Mini-cog during study screening
- Self-reported or electronic health record (EHR) documented thoracic imaging surveillance for cancer or chronic lung disease
Laborértékek
- Self-reported or EHR diagnosis of severe illness on chart review defined as:
- Hospice
- End Stage Pulmonary disease or continuous supplemental oxygen use
- Heart Failure with ejection fraction (EF) less than 25%
- Transplant of any organ or bone marrow
- Active cancer currently being treated except non-melanoma skin cancer
- Condition that precludes lung cancer screening due to limited ability to undergo treatment as deemed by study PI
Egyéb
- Pregnancy in the second or third trimester
- Inability to give informed consent; no minors, prisoners, or incapacitated
- Inability to complete computed tomography (CT) scan
Kiket keres a vizsgálat
- 1.Date of birth and sex recorded 2.Active user of VA (at least 1 primary care encounter in prior 2 years) at Nashville, Denver, Louisville, Chicago Jesse Brown, Kansas City, Salisbury or Seattle VAMC 3.Tobacco Use: Self-reported tobacco use of at least 100 cigarettes in lifetime 4.Additional Risk Factor
- Self-reported history of military service exposure: direct contact with asbestos- containing material, agent orange, ionizing radiation or burn pit
- Chronic obstructive pulmonary disease (COPD) defined as one of the two definitions below:
- Forced expiratory volume during the first second/forced vital capacity (FEV1/ FVC) ratio of below 70% predicted
- FEV1/FVC greater than 70% predicted or pulmonary function test (PFT) unavailable plus respiratory symptoms (chronic cough, sputum production, shortness of breath, chest tightness, wheezing) plus any one of the following functional abnormalities on PFTs or structural abnormalities on imaging:
- Functional abnormalities on PFTs:
- FEV1 below the lower limit of normal
- Gas trapping defined as residual volume greater than upper limit of normal
- Hyperinflation defined as two out of three lung volumes (total lung capacity, functional residual capacity, residual volume) that are greater than the upper limit of normal
- Reduced diffusion capacity of the lungs for carbon monoxide (DLCO) defined as DLCO lower than the lower limit of normal
- Rapid FEV1 decline defined as greater than 60ml/year or greater than or equal to 15% decline in FEV1
- Structural abnormalities on imaging:
- Emphysema
- Air trapping/mosaicism
- Self-reported prior history of tobacco-related cancer (oral cavity and pharynx, esophagus, stomach, colorectal, liver and intrahepatic bile duct, pancreas, larynx, lung and bronchus, cervix uteri, kidney and renal pelvis, urinary bladder, and acute non-lymphocytic leukemia) and without evidence of disease for at least 5 years based on chart review
- Self-reported family history of primary lung cancer in a first degree relative e .No exclusion criteria at study screening
Életkor a regiszterben: 50 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (7)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Egyesült Államok | Ismeretlen állapot |
| Jesse Brown VA Medical Center, Chicago, IL | Chicago | Egyesült Államok | Ismeretlen állapot |
| Kansas City VA Medical Center, Kansas City, MO | Kansas City | Egyesült Államok | Ismeretlen állapot |
| Robley Rex VA Medical Center, Louisville, KY | Louisville | Egyesült Államok | Ismeretlen állapot |
| Tennessee Valley Healthcare System Nashville Campus, Nashville, TN | Nashville | Egyesült Államok | Ismeretlen állapot |
| Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC | Salisbury | Egyesült Államok | Ismeretlen állapot |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.