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CHAMP Lung Cancer Screening Program (CHAMP)

12. června 2026 aktualizováno: Jill Kolesar

CHAMP: Community Health Assessment and Monitoring in the Pharmacy. Assessing the Impact of a Community Pharmacist Lung Cancer Screening (LCS) Program

The U.S. Preventive Services Task Force recommends annual lung cancer screening (LCS) with low-dose CT for adults aged 50-80 with a ≥20 pack-year smoking history who currently smoke or quit within the past 15 years. Despite insurance coverage, only 17% of eligible Iowans were screened in 2024. Barriers include the complexity of screening and competing demands in primary care. To address these challenges, investigators propose a two-part intervention: a blood-based screening test to simplify LCS and a community pharmacist-led referral program integrated into routine pharmacy care.

Eligible patients will be identified at Greenwood Pharmacy in Waterloo, Iowa. Interested individuals will be consented by a pharmacist and engaged in shared decision-making about LCS. Participants may decline screening, complete the DELFI Diagnostics FirstLook lung cancer screening blood test, or pursue CT screening through their primary care physician. Those choosing the blood test will be referred to Cedar Valley Family Medicine. Patients with a positive result will complete a standard shared decision-making visit with their PCP and, if appropriate, undergo confirmatory CT imaging. Patients with a negative result will enter a screening cohort and be re-screened annually for an additional year.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

The US Preventive Services Task Force recommends annual lung cancer screening (LCS) with low dose Computerized Tomography (CT) scans for adults aged 50-80 with a 20-pack year smoking history who are current smokers or who have quit within the last 15 years. Despite these recommendations and Medicaid/Medicare coverage, only about 17% of eligible patients were screened in Iowa in 2024. Barriers to implementing LCS are multifactorial and include patient and clinician barriers, specifically complexity of screening and primary care physician competing demands. To overcome these barriers, investigators propose a two-part intervention: first, a blood test, that reduces the complexity of lung cancer screening and second, a community pharmacist referral program that can be performed as part of routine care received in the pharmacy.

LCS eligible participants will be identified in Greenwood Pharmacy in Waterloo, Iowa and invited to participate in a lung cancer screening study. If they are interested, the pharmacist will review the consent form with them, explaining the study and answering any questions they have. After the consent is signed, the participant will engage in a shared decision-making conversation about LCS with the pharmacist. As part of this conversation, patients will be told they are eligible for LCS and given three options: Decline to participate; agree to participate and get DELFI blood test; or agree to participate but decline blood test and pursue a CT scan with their PCP. Patients agreeable to the blood test will be referred to Cedar Valley Family Medicine, where they can receive the DELFI FirstLook Lung Cancer Screening Test. Those with a positive (elevated) blood test will have a standard of care clinic appointment with the primary care physician at Cedar Valley Family Medicine for a shared decision-making visit about LCS and if warranted, order confirmatory CT scanning which is standard of care and billed to the study. Patients with a negative blood test will be added to the "Screening Cohort" and approached annually for a total of 2 years to participate in screening.

Typ studie

Intervenční

Zápis (Odhadovaný)

300

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • Iowa
      • Iowa City, Iowa, Spojené státy, 52242
        • Nábor
        • University of Iowa
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Jill Kolesar, PharmD, MS, FCCP
      • Waterloo, Iowa, Spojené státy, 50701
        • Nábor
        • Cedar Valley Primary Care & Walk-In Clinic
        • Kontakt:
        • Dílčí vyšetřovatel:
          • James Hoehns, PharmD, BCPS, FCCP
      • Waterloo, Iowa, Spojené státy, 50702
        • Nábor
        • Greenwood Pharmacy and Compounding Center
        • Kontakt:
          • Robert Nichols, PharmD, BCPS

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • aged 50-77
  • smoking pack-year history of ≥ 20 years
  • current smoker or quit smoking 15 or less years ago
  • ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

  • self-report of lung cancer screening in the last 12 months
  • psychiatric illness/social situations that would limit compliance with study requirements

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Promítání
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: DELFI FirstLook Lung Cancer Screening Blood Test

Participants may choose to receive the DELFI Diagnostics FirstLook Lung test, a blood-based screening test designed to support early detection of lung cancer. The test analyzes patterns in cell-free DNA fragments using whole-genome sequencing and machine-learning techniques. Designed to augment traditional low-dose CT screening, it offers a minimally invasive and accessible option for early lung cancer detection.

If a participant elects to receive this test, a blood sample will be collected at a study clinic and sent to a DELFI Diagnostics lab without any personal identifying health information attached. After processing, results are returned to the study team. Participants will be notified if results are not elevated, in which case repeating the test in one year is recommended. If results are elevated, study staff will recommend follow-up screening with a low-dose CT scan from local clinic for further evaluation.

Both the blood test and CT will be provided by the study at no cost.
Diagnostický test: DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test
A participant can choose to receive this test. This is done by receiving a blood draw. The blood sample is sent to the DELFI Diagnositics lab without any personal health information attached. Results will be relayed to the participant as either "elevated" or "not elevated". IF the result is "elevated" the participant will be recommended to receive a low-dose CT scan.
Aktivní komparátor: Low-Dose CT
Participants can choose to follow current US Preventive Services Task Force recommendations of a low-dose CT scan ordered through their primary care physician.
Diagnostický test: Low-Does CT Scan
If a participant chooses this arm, the participant will request their primary care physician to order them a low-dose CT scan as part of the USPSTF standards for lung cancer screening. Participants will be asked to fax the results of those scans to the study.
Žádný zásah: No lung cancer screening
Participants chose to not participate in lung cancer screening. Annually, participants will be informed about lung cancer screening options and given the opportunity to participate in one of the screening options. Participants will have the ability to change their mind and choose one of the lung cancer screening options in between their annual screening discussion.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of pharmacy patrons receiving lung cancer screening
Časové okno: From enrollment through six months after enrollment
To determine the proportion of pharmacy patrons eligible for lung cancer screening who accept a pharmacist's recommendation for screening and subsequently undergo lung cancer screening.
From enrollment through six months after enrollment

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of eligible participants that receive a DELFI Diagnostics FirstLook lung cancer screening blood test
Časové okno: From enrollment through six months after enrollment
What proportion of enrolled participants choose to receive a DELFI Diagnostics FirstLook lung cancer screening blood test as their lung cancer screening option.
From enrollment through six months after enrollment
Determine the proportion of eligible participants that receive a low-dose CT scan
Časové okno: From enrollment through six months after enrollment
What proportion of eligible participants offered lung cancer screening by a pharmacist accept the recommendation and undergo lung cancer screening by low-dose CT scan.
From enrollment through six months after enrollment
Correlations between demographic data and declining of initial screening
Časové okno: From time of enrollment through 30 days after enrollment
Correlations between demographic factors and declining of initial screening will be assessed univariably using two-sample t-tests for quantitative factors and Pearson's chi-squared tests for qualitative factors. The sample size is expected to be large enough to justify the distributional assumptions of these tests, but if that is not the case, then non-parametric Wilcoxon rank-sum and Fisher's exact tests will be used instead. Multivariable effects of demographic factors will be modeled with logistic regression. Frequency of year 2 and 3 completion of screening will be estimated with binomial proportions.
From time of enrollment through 30 days after enrollment
Frequency of individuals who complete screening in year 1 that return for screening in year 2
Časové okno: From 12 through 18 months after initial enrollment
Determine the frequency of individuals who complete screening in year 1 that return for screening in year 2.
From 12 through 18 months after initial enrollment

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Rate of positive DELFI Diagnostics FirstLook lung cancer screening tests
Časové okno: From enrollment through 12 months after enrollment
Determine the rate of positive DELFI tests.
From enrollment through 12 months after enrollment
Diagnostic CT completion rate among participants with a positive DELFI Diagnostics FirstLook lung cancer screening test
Časové okno: From time of positive DELFI test through 12 months after test results
Determine what percentage of participants with a positive DELFI Diagnostics FirstLook lung cancer screening test complete the recommended low-dose CT scan.
From time of positive DELFI test through 12 months after test results
Percentage of participants diagnosed with lung cancer
Časové okno: From time of CT scan until completion of study, up to three years
Determine percentage of participants diagnosed with lung cancer among those ultimately completing diagnostic CT scans.
From time of CT scan until completion of study, up to three years
Positive DELFI Diagnostics Firstlook lung cancer screening test correlation to clinical demographics and lung cancer detection
Časové okno: After completing data collection upon study completion, three years
Rates of positive DELFI tests, CT completion, and diagnosed lung cancers will be estimated with binomial proportion and exact Clopper-Pearson 95% confidence intervals. Associations between DELFI test positivity and demographic factors will be assessed univariably with non-parametric Wilcoxon rank-sum tests for quantitative factors and Fisher's exact tests for qualitative factors.
After completing data collection upon study completion, three years
Participant decisional conflict as measured by the Traditional Decisional Conflict Scale (DCS)
Časové okno: From enrollment through 30 days after enrollment
The DCS consists of 16 items with 5 response categories ranging from strongly agree to strongly disagree
From enrollment through 30 days after enrollment

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Jill Kolesar

Spolupracovníci

Eli Lilly and Company

Vyšetřovatelé

  • Vrchní vyšetřovatel: Jill Kolesar, PharmD, MS, FCCP, University of Iowa

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

12. června 2026

Primární dokončení (Odhadovaný)

1. června 2028

Dokončení studie (Odhadovaný)

1. června 2028

Termíny zápisu do studia

První předloženo

23. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

30. dubna 2026

První zveřejněno (Aktuální)

7. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 202512332

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

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