Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

participants performed lung cancer screening by Low Dose CT scan

Low dose CT scan

olivier LELEU

Lung cancer is the leading cause of cancer death worldwide. The aims of this study were to assess the feasibility and effectiveness of a lung cancer screening pilot program with LD CT scan in a French department (Somme).

DEP KP80 was a single-arm, prospective study started in May 2016. The inclusion criteria were those of the National Lung Screening Trial. An annual LD CT scan was scheduled and 2 rounds were planned. Smoking cessation was encouraged as part of the protocol.

Subjects were selected by General Practitioner or Pneumologist who checked the inclusion criteria and prescribed the CT scan.

Scientific context :

Lung cancer is the deadliest cancer in France and in the world. With around 39500 new cases in 2012 in France, lung cancer ranks fourth regarding cancer incidence for both women and men. In 2012 it caused the highest number of annual deaths linked to cancer (around 30 000 deaths) according to the Institut National Du Cancer (INCA). It is a real public health issue, its incidence has been increasing above all in women and its prognosis is grim. The 1-year survival rate is 43% and 5-year survival rate 14% whatever the stage of the disease.

The Picardy region presents an excess mortality of 18% compared to the national average for the lung cancer and Somme has one of the highest incidence rate in France for this cancer.

Research hypothesis:

If the investigators know that tobacco smoke is the main risk factor, the other feature of this cancer is characterized by a diagnosis at an advanced stage when only limited, palliative treatments which are heavy, and costly can be provided Proposing the screening test with low dose helical computed tomography (LD-CT) has the aim to spot this cancer at an early stage when a curative surgical treatment is still possible in order to improve the survival chances.

Indeed screening by low dose CT showed a decrease of the death rate by 20 % of lung cancer and by 6 % for all the causes in the National Lung Screening Trial published in 2011.

If this screening test has for goal to diagnose lung cancers at an early stage, it also highlights in a quarter of the cases benign abnormalities requiring mainly further non invasive explorations. This low specificity is one of the reasons why in France the Haute Autorite Sante (HAS) has concluded that the current conditions were not met to authorize this screening in general population and insist on carrying the research for this screening.

Decreasing the number of false positives by selecting the targeted population and optimizing the decision algorithms would enable to improve the specificity of low dose CT as screening test of lung cancer.

Description of the intervention:

The rationale of this project is to use already existing networks among health care providers and between the health care providers and the departmental cancer screening agency (ADEMA 80) which is already in charge with the breast and colon cancer screening.

The targeted population of this screening concerns men and women from 55 to 74 year old who are smoking with a tobacco exposure of more than 30 pack-years or those who stopped for less than 15 years without obvious symptoms and who accept the screening tests with information on the results and the consequences which can arise ( non invasive exploration , CT after 3 months, Positon Emission Tomography scan or invasive exploration : CT guided biopsy, bronchoscopy, surgical exploration ) and who signed a consent form.

People with a history of cancer of less than 5 years, worsening of their health state, heart or respiratory morbidities which prevent a chest surgery are excluded of this study.

The population which is likely to undergo this test (male and female smokers from 55 to 74 years old) is estimated to 48 000 inhabitants for the department of the Somme which has a total population of 584 000 inhabitants.

The screening test is offered by primary care doctors and pneumologists of the Somme whom an invitation was sent by mail and who have accepted the way and means of the study.

The CT is prescribed on a prescription pad with 3 carbonless documents delivered by ADEMA 80 to the participating doctors: a part for the patient in order to take an appointment for his exam, one part which is sent back to ADEMA 80 with a prepaid envelope to keep a track and one part for the prescribing doctor. The LD-CT is carried out in radiology centers which comply with the charter of good practice of LD-CT.

The General Practitioners (GPs) and the pneumologists deal with the management of abnormalities which are eventually found by the CT according to the decision algorithms defined by the steering committee which has also validated a standard CT report. If the LD-CT proves to be normal, the screening is negative, the patient is invited again by ADEMA 80 the following year for a new LD-CT.

If the CT is abnormal , depending on the nodule' s size and/or nature either a new LD-CT is carried out after 3 months or if the screening is positive the patient's case is presented during a multidisciplinary team meeting with pneumologists, radiologists, oncologists, thoracic surgeons, pathologists.

Participants of the screening are being made aware of the benefits of quitting smoking and refer to a consultation on tobacco control if necessary.

A copy of the CT results is given to the local cancer screening agency (ADEMA 80) which is in charge with keeping a track and with statistic analyses.

This is a study with 2-year inclusion period. The length of the study is of 3 years.

It is the first study of lung cancer screening by LD-CT which is made at a regional scale in France.

Expected public health impact. The main objective of this screening is to assess the feasibility of an organized individual screening by LD-CT for a heavy smoker population aged from 55 to 74 in the Somme department, department with high incidence of lung cancer.

The secondary goals are to determine incidence of false positives, the number of screened cancers and staging, the histological subtypes, the sensibility and the specificity of this screening, to assess the treatments which have been implemented and the time it takes to deliver appropriate, to rate the quality of life and assess the incentive means to quit smoking

Lung Cancer Screening by Low Dose CT Scan in a French Department (DEP KP80)

number of participants, participation rate : number of LD CT scan performed/ number of participants

number of lung cancer diagnosed, number of stage I, rate of surgery, rate of false positive

Centre Hospitalier d'Abbeville

Head of pneumology department

Men and women current daily smokers or former smokers, Aged ≥ 50

A low dose CT scan of the lungs is performed after the inclusion of the patient in the study and if negative for active disease, a CT scan if performed once per year for whole period of follow-up

Massimo Bellomi, PhD

The purpose of this study is to offer annual low-dose spiral CT radiological examination for 5 years to 5000 volunteers from the general population who are considered to be at high risk of developing lung cancer.

Lung carcinoma is one the most fatal cancer in the world. The enormous fatality rate reflects the limited chance of cure, with a dismal overall 5-year survival rate of approximately 14%. The prognosis of lung cancer depends largely on early detection and immediate treatment prior to metastatic spread. For Stage 1 lung cancer the 5-year survival rate can be as high as 70% . These data suggest that early detection and surgical treatment would have a huge beneficial effect on the lung cancer population. We developed a single arm observational study for the early detection of lung cancer with low dose CT scan in high risk asymptomatic subjects. A mainly non invasive algorithm for management of undetermined nodules was designed including low dose CT at three months for baseline nodules with diameter between 5 and 8 mm, a PET scan for nodules larger that 8 mm (not reduced after antibiotics and one month follow up CT). Lesions increasing in diameter or in density or positive nodules at CT/PET were sent to surgical biopsy (videothoracoscopic approach preferred).

Spirometry was done in all subjects prior to CT scan to evaluate correlation between BPCO and lung cancer.

Continuous Observation of Smoking Subject

Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population

Associazione Italiana per la Ricerca sul Cancro

European Institute of Oncology

Heart and Blood Diseases

Atherosclerosis

Lung cancer screening will be based on the analysis of a low dose CT scan

low dose CT scan

establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota

blood sample collection

faecal sample collection

Lung cancer is the main cause of mortality by cancer in France. The lung cancer stage at time of diagnosis is a major determinant of survival. To date, 75% of lung cancer are diagnosed at an advanced stage with worse survival). Lung cancer screening is based on low dose CT scan which allows to decrease lung cancer related mortality of 20% in patients aged 55-74 years-old with a history of tobacco consumption ≥ 30 PY active of who quite \< 15 years. These criteria for eligibility for lung cancer screening lead to 1 to 2% of lung cancer diagnosis at the first CT scan. In our experience regarding 1 year of lung cancer surgical resection, only 45% of the patients presented criteria for lung cancer screening. Moreover, the duration of tobacco consumption would provide a better stratification of lung cancer risk compared to only PY. Therefore, other criteria for lung cancer screening eligibility could be proposed. Currently, 9 out of 10 lung cancer is linked with tobacco consumption which is also a major risk factor for atherosclerosis-associated cardiovascular events. Around 40% of patients with a lung cancer have a history of atherosclerosis-associated cardiovascular event, mainly coronary artery diseases and peripheral artery diseases. Main Objective: The objective is to compare the observed rate of lung cancer prevalence in our study to the rate of around 2 % observed in lung cancer screening trials in south Europe (France and Italy).

The investigators hypothesize that the population of patients with a history of atherosclerotic cardiovascular event associated with tobacco consumption present a higher prevalence of lung cancer compared with the population of patients eligible for lung cancer screening program which is defined by age and history of tobacco consumption.

Epidemiological Study to Assess the Prevalence of Lung Cancer

Epidemiological Study to Assess the Prevalence of Lung Cancer in Patients With Smocking-associated Atherosclerotic Cardiovascular Diseases

estimation of the prevalence of lung cancer among patients managed for atherosclerosis-related cardiovascular events associated with tobacco consumption.

Centre Chirurgical Marie Lannelongue

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

All participants are invited to undergo a low dose CT thorax

A low dose CT scan of the thorax to screen for lung cancer

Low dose CT thorax

A single site non-commercial study in which people treated for Hodgkin lymphoma survivors will be invited to have a single low dose CT of thorax for lung cancer screening

Lung Screening in People Cured of Hodgkin Lymphoma

Lung Screening for Hodgkin Lymphoma Survivors: a Feasibility Study

University of Manchester

The Christie NHS Foundation Trust

25,000 individuals who are at high-risk for lung cancer due to a significant smoking history.

Participants will receive at least 1 LDCT scan at baseline.

Low Dose chest CT scan conferring an equivalent radiation dose of less than 2 mSv to the average size patient. The study aims to keep most scans under 1 mSv (ultra-low dose), and all scans under 2 mSv.

Low Dose CT scan

The SUMMIT Study will enrol 13,000 participants in order to investigate how cancer screening can be improved and delivered. The SUMMIT Study has two main aims: the first is to clinically validate a blood test for detecting multiple cancers at an early stage. The second is to examine the feasibility of delivering a low-dose CT (LDCT) screening service for lung cancer to a high-risk population in North Central and East London.

The SUMMIT Study is a prospective, observational, cohort study. Its aim is to clinically validate a blood test for the early detection of multiple types of cancer, and to deliver LDCT screening for lung cancer to an at-risk population.

SUMMIT plans to enrol 13,000 participants aged 55-77 years, from participating general practitioner (GP) practices in North Central and East London. The participants enrolled will be people who are at high-risk for lung cancer due to a significant smoking history based on validated risk scores.

Individuals with significant smoking histories will be offered a clinical Lung Health Check (LHC), which includes a brief respiratory consultation including questions about respiratory symptoms and medical history, smoking cessation advice and referral where required, and certain relevant clinical measurements (blood pressure, spirometry, height, and weight). Those persons who are eligible for participation based on specific validated risk scores may then be offered participation in the SUMMIT Study. Electronic informed consent will be obtained if they decide to take part. Consented participants will provide a blood sample, complete a confidential electronic questionnaire and have an LDCT scan at the same visit. Participants will be asked to return for two further annual visits, and some participants may return for additional scans if clinically indicated (nodule management).

If any LDCT result is suspicious for cancer, the participant will be referred to their local hospital (type 2 Site) via an urgent referral pathway to the relevant MDT. If a participant is diagnosed with lung cancer, that participant will no longer continue in the active/interventional part of the study but will be followed for clinical outcomes via the Type 2 site completion of eCRF and registry data. If the suspicious lesion is found to be benign, the participant can continue in the study.

There will be one randomisation round carried out during this study. All participants with a negative LDCT at the baseline visit who have not been diagnosed with lung cancer since that visit will return for an LHC at approximately 12 months. At the 12-month visit, this group will be randomised either to have an LDCT or no LDCT.

However, if an urgent referral was after the Y0 LDCT scan, the participant will not be included in the randomisation at Y1, and will receive LDCT at Y1 and Y2.

Blood samples will be taken at each visit and sent to GRAIL to clinically validate a blood test for detecting multiple cancers at an early stage. An additional blood sample will be collected for (and stored by) UCL for future research.

The SUMMIT Study: A Cancer Screening Study

The SUMMIT Study: Cancer Screening Study With or Without Low Dose Lung CT to Validate a Multi-cancer Early Detection Test

Cancer incidence associated with screening test performance:

* Sensitivity
* False positive rate (1-specificity), specificity
* Positive predictive value (PPV)
* Negative predictive value (NPV)

Performance indicators that will be measured include the number of:

* eligible participants who choose to have an LDCT.
* characteristics of those who choose to have LDCT, e.g. age, sex, ethnicity, area-level deprivation score and smoking status.
* people who have a baseline LDCT who attend at year 1 and also at year 2.
* screen-detected cancers per 1000 screened
* early stage screen-detected cancers per 1000 screened
* late stage screen-detected cancers per 1000 screened
* people referred for diagnostic investigations per 1000 screened
* people who have a biopsy per 1000 screened
* malignant and benign tumours detected
* incidence per 1000 per year

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lung Cancer Screening by Low Dose CT Scan in a French Department (DEP KP80)	NCT03853967	Lung Cancer Scr...	Low dose CT sca...	55 Years - 74 Years	Centre Hospitalier d'Abbeville
Continuous Observation of Smoking Subject	NCT01248806	Subjects at Hig...	Low dose CT sca...	50 Years -	European Institute of Oncology
Epidemiological Study to Assess the Prevalence of Lung Cancer	NCT03976804	Lung Cancer Tobacco Atherosclerotic...	low dose CT sca... blood sample co... faecal sample c...	45 Years - 75 Years	Centre Chirurgical Marie Lannelongue
Lung Screening in People Cured of Hodgkin Lymphoma	NCT04986189	Hodgkin Lymphom... Lung Cancer	Low dose CT tho...	18 Years - 80 Years	The Christie NHS Foundation Trust
The SUMMIT Study: A Cancer Screening Study	NCT03934866	Cancer Lung Cancer	Low Dose CT sca...	55 Years - 77 Years	University College, London
Lung Screening in People Cured of Hodgkin Lymphoma	NCT04986189	Hodgkin Lymphom... Lung Cancer	Low dose CT tho...	18 Years - 80 Years	The Christie NHS Foundation Trust
Epidemiological Study to Assess the Prevalence of Lung Cancer	NCT03976804	Lung Cancer Tobacco Atherosclerotic...	low dose CT sca... blood sample co... faecal sample c...	45 Years - 75 Years	Centre Chirurgical Marie Lannelongue
Epidemiological Study to Assess the Prevalence of Lung Cancer	NCT03976804	Lung Cancer Tobacco Atherosclerotic...	low dose CT sca... blood sample co... faecal sample c...	45 Years - 75 Years	Centre Chirurgical Marie Lannelongue
Epidemiological Study to Assess the Prevalence of Lung Cancer	NCT03976804	Lung Cancer Tobacco Atherosclerotic...	low dose CT sca... blood sample co... faecal sample c...	45 Years - 75 Years	Centre Chirurgical Marie Lannelongue
Continuous Observation of Smoking Subject	NCT01248806	Subjects at Hig...	Low dose CT sca...	50 Years -	European Institute of Oncology
The SUMMIT Study: A Cancer Screening Study	NCT03934866	Cancer Lung Cancer	Low Dose CT sca...	55 Years - 77 Years	University College, London
Lung Cancer Screening by Low Dose CT Scan in a French Department (DEP KP80)	NCT03853967	Lung Cancer Scr...	Low dose CT sca...	55 Years - 74 Years	Centre Hospitalier d'Abbeville

Spots Global Cancer Trial Database for low dose ct scan