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O estudo clínico NCT04913155 (HANSE) para Câncer de pulmão está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Escola de Medicina de HanôverHANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort 12.100
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O estudo clínico NCT04913155 (HANSE) é um estudo intervencionista para Câncer de pulmão. Seu status atual é: ativo, não recrutando. O estudo começou em 20 de maio de 2021 e pretende incluir 12.100 participantes. Coordenado por a Escola de Medicina de Hanôver e deve ser concluído em 1 de janeiro de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 3 de outubro de 2025.
Resumo
The HANSE study is primarily intended as a pilot to provide evidence that a holistic and effective lung cancer screening program can be implemented in Germany and that such a screening program can be integrated in the current infrastructure of certified lung cancer centers.
Descrição detalhada
Germany has a long history of offering screening programs for cancers, such as breast, colorectal, and, more recently, cervical and skin cancer. Screening for lung cancer, however, which causes more deaths than any other cancer in men and is the second leading cancer death in women (not far behind breast cancer), has not been implemented to date. Only very recently, Institute for Quality and Efficiency in Healthcare ...Mostrar mais
Título oficial
HANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort, Population-based Screening Study -Prospective, Randomized Comparator Controlled
Condições médicas
Câncer de pulmãoPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- HANSE
- ESR-20-20770
Número NCT
Data de início (real)
2021-05-20
Última atualização postada
2025-10-03
Data de conclusão (estimada)
2028-01
Inscrição (estimada)
12.100
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ativo, não recrutando
Palavras-chave
Lung cancer
Screening program
Low-dose CT
Screening program
Low-dose CT
Propósito principal
Triagem
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Cego simples
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
OutroReporting group (coronary calcium score and emphysema score) Coronary calcium score and emphysema score are reported to subjects | Low-dose CT screening Low-dose computed tomography with lung nodule evaluation (LungRADS1.1, highrisk score group), randomized reporting of coronary artery calcium score and emphysema score |
OutroReporting group (coronary calcium score only) Only coronary calcium score is reported to subjects | Low-dose CT screening Low-dose computed tomography with lung nodule evaluation (LungRADS1.1, highrisk score group), randomized reporting of coronary artery calcium score and emphysema score |
OutroReporting group (emphysema score only) Only emphysema score is reported to subjects | Low-dose CT screening Low-dose computed tomography with lung nodule evaluation (LungRADS1.1, highrisk score group), randomized reporting of coronary artery calcium score and emphysema score |
OutroNon-reporting group Coronary calcium score and emphysema score are not reported to subjects | Low-dose CT screening Low-dose computed tomography with lung nodule evaluation (LungRADS1.1, highrisk score group), randomized reporting of coronary artery calcium score and emphysema score |
Nenhuma intervençãoLow-risk group No CT screening, collection of health data only | N/A |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Primary endpoint | Positive predictive value (PPV) for lung cancer detection with different inclusion methods (NELSON vs. PLCO) after 2 screening rounds. | 5 years |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Key secondary endpoint 1 | Proportion of individuals selected for screening within the high-risk population. | 1 year |
Key secondary endpoint 2 | Proportion of lung cancers detected with different inclusion methods (NELSON vs. PLCO) within the overall study population after 5 years. | 5 years |
Key secondary endpoint 3 | Proportion of lung cancers detected with in the high-risk population after 5 years. | 5 years |
Key secondary endpoint 4 | Specificity within the overall population after 5-year follow-up. | 5 years |
Key secondary endpoint 5 | Sensitivity within the overall population after 5-year follow-up. | 5 years |
Additional secondary endpoint 1 | Rate of initiation of cardiovascular treatments (in particular lipid-lowering) in the calcium score reporting group vs. the non-reporting group after year 1 of study. | 1 year |
Additional secondary endpoint 2 | Efficiency of nodule management algorithms (LungRads1.1 + PanCan) will be evaluated according to the number of patients sorted in the category (a) "Next surveillance scan" AND the number of patients with lung cancer sorted into category (b) "early recall scan", or (c) "diagnostic evaluation". | 1 year |
Additional secondary endpoint 3.1 | Success of screening program. Based on all individuals enrolled. Definition of success is calculated using Response rate. | 1 year |
Additional secondary endpoint 3.2 | Success of screening program. Based on all individuals enrolled. Definition of success is calculated using Reliability of PLCO risk scoring (self-reported vs. on site assessment). | 1 year |
Additional secondary endpoint 3.3 | Success of screening program. Based on all individuals enrolled. Definition of success is calculated using Percentage of subjects receiving an adequate low-dose CT scan and report according to DRG guidelines (number of diagnostic CTs/number of all CTs). | 1 year |
Additional secondary endpoint 3.4 | Success of screening program. Based on all individuals enrolled. Definition of success is calculated using Percentage of subjects receiving adequate follow-up procedures. | 1 year |
Additional secondary endpoint 4.1 | Quality of screening program: CT reading performance (2nd reader vs. CAD vs. AI) | 1 year |
Additional secondary endpoint 4.2 | Quality of screening program: Quality of lung nodule management | 1 year |
Additional secondary endpoint 4.3 | Quality of screening program: Frequency of detection and management of incidental findings from low dose chest CT (emphysema, coronary heart disease, etc.) | 1 year |
Additional secondary endpoint 4.4 | Quality of screening program: LDCT dose management | 1 year |
Additional secondary endpoint 5 | Smoking cessation: Success of smoking cessation counseling based on number of participants quitting with or without revealing additional health risks (emphysema score, coronary calcium score or both). | 1 year |
Additional secondary endpoint 6.1 | Identification of blood-based biomarkers for early detection of lung tumors: Blood collection and evaluation of various blood-based epigenetic biomarkers in positive LDCT cases with subsequent biopsy on the positive predictive value of the LDCT test. | 1 year |
Additional secondary endpoint 6.2 | Identification of exhalation-based biomarkers for early detection of lung tumors: Collection of breath condensate and evaluation of various exhalation-based epigenetic biomarkers in positive LDCT cases with subsequent biopsy on the positive predictive value of the LDCT test. | 1 year |
Additional secondary endpoint 7.1 | Cost-effectiveness analysis: Main objectives of the modelling study are to investigate the impact of different components of LDCT lung cancer screening on the long-term all-cause mortality and cost-effectiveness. Key components include risk score-based selection criteria, nodule management protocols, threshold values of imaging biomarkers for cardio-vascular diseases and COPD, and inclusion of smoking cessation programs (performed by Center for Health Economics Research Hannover (CHERH). | 1 year |
Additional secondary endpoint 7.2 | Cost-effectiveness analysis: Comparison of patient recruitment strategies: Cost-effectiveness of register-based mailing campaign vs. GP referrals in terms of recruitment of qualified screening subjects (Center for Health Economics Research Hannover - CHERH). | 1 year |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
55 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
- Male and female subjects aged 55-79 years
- Current or former smokers
- Subjects with calculated risk score PLCOM2012 ≥1.58% (6 yrs.) or NELSON inclusion criteria (current or former smokers \[those who had quit ≤10 years ago\] who had smoked >15 cigarettes a day for >25 years or >10 cigarettes a day for >30 years).
- Able and willing to give written informed consent In addition, non-qualifying subjects fulfilling inclusion criteria 1 (age), 2 (smoking history) and 4 (consent), but do not meet the inclusion criterion 3 (risk too low) will be asked to volunteer by contributing long-term outcome data informing of the development of lung cancer or death from lung cancer (about n=7100 randomly selected from all 3 centers, low-risk group). These subjects will be contacted via mail after a minimum of 5 year follow up to inquire if they developed lung cancer in the time between their recruitment and present. Non-responders will be followed by local registries and by phone. New lung cancer cases will be verified using official hospital or cancer registry documents.
Comorbidity, which would unequivocally contraindicate either screening or treatment if lung cancer is detected.
History of chest CT within the past year preceding the invitation.
Inability to undergo non-contrast CT (e.g. ≥ 200 kg body weight, inability to lie flat).
Pregnancy
Risk of non-compliance with study procedures.
- Unable to give written consent
- Patient's inability to fill in the questionnaire self-dependent
- Limited knowledge of the German language
- Inability to travel, residents of care facilities, etc.
Escola de Medicina de Hanôver- 🏥Lu...
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3 Locais do estudo em 1 países
Lower Saxony
Medizinische Hochschule Hannover, Hanover, Lower Saxony, 30625, Germany
Schleswig-Holstein
LungenClinic Grosshansdorf, Großhansdorf, Schleswig-Holstein, 22927, Germany
Universitätsklinikum Schleswig-Holstein, Lübeck, Schleswig-Holstein, 23538, Germany