Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Wounds and Injuries

Digestive System Diseases

Prostatic Neoplasms

Urinary Bladder Neoplasms

Lung Injury

Pneumoperitoneum

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Peritoneal Diseases

Gastrointestinal Diseases

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Lung Diseases

Respiratory Tract Diseases

Thoracic Injuries

Subjects assigned to the low-pressure pneumoperitoneum group will receive 7-10 mm Hg carbon dioxide pneumoperitoneum, and the expected duration is longer than 3 hours to complete robot-assisted surgeries in the Trendelenburg position;

Subjects assigned to the standard-pressure pneumoperitoneum group will receive 12-16 mm Hg carbon dioxide pneumoperitoneum, which is expected lasted longer than 3 hours to complete robot-assisted surgeries in the Trendelenburg position;

Using low-pressure(between 7-10 mm Hg ) pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy.

low-pressure pneumoperitoneum

Using standard-pressure (between 12-16 mm Hg )pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy.

standard-pressure pneumoperitoneum

Weidong Gu, Doctor

Xixue Zhang, Master

Rong Dong, Doctor

This study is aimed to determine whether low- and standard-pressure pneumoperitoneum have different impacts on troponin T（TnT) level as well as pulmonary complications after prolonged robot-assisted surgeries in the Trendelenburg position.

The hypothesis of this study is based on several studies reported that increased postoperative troponin T(TnT) level was significantly associated with 30-day mortality, and some other reports showed that low-pressure pneumoperitoneum had better haemodynamic outcome than that of standard-pressure pneumoperitoneum. Hence, we hypothesize that different pneumoperitoneal pressure may lead to different levels of TnT after prolonged robot-assisted surgeries.

This clinical trial will be conducted in Huadong Hospital Affiliated to Fudan University and Ruijin Hospital Shanghai Jiao Tong University School of Medicine,both are tertiary hospitals in Shanghai, China.

After signing the Informed Consent, subjects who meet the eligibility criteria will be randomly assigned to low- or standard-pressure pneumoperitoneum group.The randomization plans will be implemented using statistical software R, and will be stored in an online database.These subjects will be recruited from January 1st 2016 to December 31st 2017.

TnT is set as the primary endpoint for this trial to evaluate the myocardial injuries, and will be measured for each patient who will undergo in-patient robot-assisted urological surgery within 24 hours postoperatively using the fourth-generation high-sensitivity TnT assay.

The total sample size will be 280.With 140 patients in each of the two treatment groups, the power will be at least 0.70 to detect an increment of TnT level among 80% of subjects.Chest CT scan is used to diagnose the pulmonary complications on the third day postoperatively.

Data will be collected to analysize whether prolonged different intraperitoneal pressure has different impacts on cardiopulmonary injuries.

Impacts of Different Pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery

Comparison of the Impacts of Prolonged Low-pressure and Standard-pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery in the Trendelenburg Position: a Bi-center, Randomized Controlled Trial

Ruijin Hospital

Huadong Hospital

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Jean-Claude Pairon, Pr

Fleur Delva, MD

Patrick Brochard, Pr

Catherine Verdun-Esquer, MD

David LUCAS, Dr

Jean-Dominique Dewitte, MD

Bénédicte Clin-Godart, Pr

Nadia Abdessemed, MD

Pascal Andujar, Pr

Mireille Matrat, MD

Christophe Paris, Pr

Jean-François Gehanno, Pr

Antoine Gislard, MD

Olivier Bylicki, Dr

Olivier Bylicki, MD

The good clinical practice guidelines for the surveillance of workers after occupational exposure to lung carcinogens were approved by the Haute Autorité de la Santé (French National Authority for Health) and the Institut National du Cancer (French National Cancer Institute) in December 2015 and one recommendation of these guidelines concerns the setting-up of a trial of low-dose chest computed tomography (CT) lung cancer screening in subjects occupationally exposed to lung carcinogens at high-risk of lung cancer (Expert consensus).

In LUCSO study, the investigators propose to conduct, under strictly defined conditions, a feasibility study of lung cancer screening in a population defined as being at high risk of lung cancer according to these good clinical practice guidelines. This population consists of smokers, aged from 55 to 74 years, currently or previously exposed to International Agency for Research on Cancer lung group 1 lung carcinogens.

The primary objective of this study is to evaluate the complex organization of lung cancer screening in the target population. This evaluation will focus on the following indicators:

* Screening activity indicator: screening coverage rate over two years
* Test quality indicator: validity of self-administered questionnaires to target the high-risk population
* Examination quality indicator: lung cancer detection rate, lung cancer detection rates by stage, validity of low-dose chest CT scan
* Follow-up indicator: smoking cessation rate, mortality rate This trial will be conducted in 8 French departments, by six reference centers specialized in occupational health (SRC).

In view of the exploratory nature of this trial, it is proposed to initially test the feasibility and acceptability of lung cancer screening sequentially over the first two years (Phase 1: 2021-2023, 24 months) in only two SRC (Val-de-Marne and Gironde).

The trial will be conducted in several steps:

1. Identification of subjects currently or previously occupationally exposed to lung carcinogens by a screening invitation letter sent by Departmental Cancer Screening Centers to subjects aged from 55 to 74 years.
2. Evaluation of occupational exposure to lung carcinogens
3. Evaluation of the lung cancer risk level and verification of eligibility
4. Screening procedure: Chest CT scans will be performed by centers specialized in chest imaging
5. Lung cancer follow-up when an abnormality suggestive of lung cancer is demonstrated.

The good clinical practice guidelines for the surveillance of workers after occupational exposure to lung carcinogens were approved by the Haute Autorité de la Santé (French National Authority for Health) and the Institut National du Cancer (French National Cancer Institute) in December 2015 and the Recommendation R12 of these guidelines concerns the setting-up of a trial of low-dose chest computed tomography (CT) lung cancer screening in subjects occupationally exposed to lung carcinogens at high-risk of lung cancer (Expert consensus).

In LUCSO study, the investigators propose to conduct, under strictly defined conditions, a feasibility study of lung cancer screening in a population defined as being at high risk of lung cancer according to these good clinical practice guidelines. This population consists of smokers, aged from 55 to 74 years, currently or previously exposed to International Agency for Research on Cancer lung group 1 lung carcinogens.

The primary objective of this study is to evaluate the organization of lung cancer screening in the target population. This evaluation will focus on the following indicators:

* Screening activity indicator: screening coverage rate over two years
* Test quality indicator: validity of self-administered questionnaires to target the high-risk population
* Examination quality indicator: lung cancer detection rate, lung cancer detection rates by stage, validity of low-dose chest CT scan
* Follow-up indicator: smoking cessation rate, mortality rate

The secondary objectives of the study are:

* Describe the population recruited in each step of the protocol
* Develop a tool to identify subjects exposed to pulmonary carcinogens and with high-risk of lung cancer
* Evaluate the impact of the proposed screening programme on smoking cessation at one, two and three years.
* Evaluate the social impact of the screening campaign
* Conduct a cost-effectiveness analysis of the programme

The proposed study will take place in multidisciplinary and specialized reference centers (SRC) in various French districts participating in the programme, to welcome patients participating. It is organized into six workpackages (WP):

* WP1: Methodology - Epidemiology
* WP2: Evaluation of occupational exposure
* WP3: Imaging
* WP4: Lung cancer follow-up strategy
* WP5: Smoking cessation
* WP6: Medico-economic analysis Six specialized reference centers are proposed in four different regions in order to test a potential region effect and to allow the recruitment by each SRC of about 200 to 600 new eligible subjects per year and per department according to the population and the age pyramid of each department
* SRC1: Centre Intercommunal de Créteil for the Val-de-Marne (94), Seine-et-Marne (77), and Essonne (91) departments
* SRC2: Bordeaux University Hospital for the Gironde (33) department
* SRC3: Rennes University Hospital for the Ille-et-Vilaine (35) department
* SRC4: Brest University Hospital for the Finistère (29) department
* SRC5: Caen University Hospital for the Calvados (14) department
* SRC6: Rouen University Hospital for the Seine-Maritime (76) department

Each of these centers is voluntary and possesses the four essential prerequisites: an occupational health clinic - radiology team with specific skills in chest imaging - pulmonology team or network of pulmonologists specialized in lung cancer - smoking cessation team.

In view of the complexity of this organization, it is proposed to initially test the feasibility and acceptability of the screening programme sequentially for the first two years (24 months) in two SRCs (SRC1 and SRC2): "Phase 1: 2021-2023". It is expected to extend the study to the other SRCs after two years: "Phase 2: 2023-2029". Ad hoc adjustments will be decided for the creation of SRCs in the third year on the basis of the data acquired in the two pilot departments, especially on the expected target population participation rate. Mortality will be monitored at least until 2031.

The trial will be conducted in several steps:

1. Identification of subjects currently or previously occupationally exposed to lung carcinogens by a screening invitation letter sent by Departmental Cancer Screening Centers to subjects aged from 55 to 74 years.
2. Evaluation of occupational exposure to lung carcinogens
3. Evaluation of the lung cancer risk level and verification of eligibility
4. Screening procedure: Chest CT scans will be performed by centers specialized in chest imaging
5. Lung cancer follow-up when an abnormality suggestive of lung cancer is demonstrated.

Lung Cancer Screening in a Population Exposed to Occupational Lung Carcinogens

LUng Cancer Screening With Low-dose Computed Tomography in a Population Exposed to Occupational Lung Carcinogens

The proportion of subjects with lung cancer detected among the subjects performing the low-dose chest CT scan

The proportion of subjects performing the low-dose chest CT scan among eligible responders during the first phase of the study

The proportion of subjects with lung cancer detected among the subjects exposed to occupational carcinogens and performing the low-dose chest CT scan

The proportion of subjects with smoking cessation among smokers

University Hospital, Bordeaux

Rennes University Hospital

Centre Hospitalier Régional et Universitaire de Brest

University Hospital, Caen

Centre Hospitalier Universitaire de Rouen

Direction Centrale du Service de Santé des Armées

Centre Hospitalier Intercommunal Creteil

Symptoms and General Pathology

Rare Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Patients who are seen in the UIHC lung cancer screening clinic will be asked to undergo an additional standard chest CT scan during their UIHC clinical lung cancer screening CT scan. Additionally, data from that clinical scan and all medical records associated with nodules that were discovered by the Lung Cancer Screening, will also be collected.

Chest CT scan

Jessica Sieren, PhD

Debra OConnell Moore, MBA

The purpose of this project is to validate quantitative lung structure assessment using an automated analysis software (VIDA), for application to low dose computed tomography (LDCT) acquired for lung cancer screening. Currently the software runs on standard dose CT data. In addition, it is the plan to incorporate algorithms into the software to address assessment of any identified pulmonary lesions.

The purpose of this project is to validate quantitative lung structure assessment using an automated analysis software (VIDA), for application to low dose computed tomography (LDCT) acquired for lung cancer screening. Currently the software runs on standard dose CT data. In addition, it is the plan to incorporate algorithms into the software to address assessment of any identified pulmonary lesions.

The Lung Cancer Screening Clinic is a new program that screens a group of patients that meet a predetermined criteria, set by the program, for lung cancer. At this time primary care providers, within the UIowa network, have the ability to place an order for this screening process for their patients. The hope is to expand this program to any primary care provider in the future. Clinic staff look over the patients past medical history to determine if they fit the clinic criteria.

For this study, the study team will ask the patients seen in the lung cancer screening clinic at the University of Iowa to undergo an additional standard dose CT scan during that same visit(for comparison/validation of the software performance). For those subjects that agree to participate, the study team will also ask to collect the data and CT scans that were also collected for their clinical Lung Cancer Screening visit. For this group the study team will also ask to collect all medical records associated with nodules found at this Lung Cancer Screening visit.

The study team propose to test the performance of VIDA's existing image analysis tools for the assessment of chronic obstructive pulmonary disease (COPD), when applied to the LDCT data acquired for lung cancer screening. The study team will also develop new lung nodule evaluation functions to specifically address the clinical needs within the at-risk lung cancer patient population.

To carry out the work, the study team propose two specific aims:

1. Validate VIDA's quantitative computed tomography (QCT) metrics for COPD and emphysema utilizing the lung cancer LDCT screening cohort as compared to the standard quantitative high resolution computed tomography (HRCT) scanning protocol. With collaboration between the University of Iowa and VIDA, the study team will establish a tightly controlled, CT data acquisition protocol in our local lung cancer screening program. Data collected will incorporate thin-slice and iterative reconstructions, breath coaching to target lung inflation levels for patients and HRCT data acquisition in a sub-cohort. The VIDA analysis will be refined and the appropriate reconstruction setting identified such that the outputs from the LDCT data correlate to the HRCT (current standard) outputs.
2. Complete and refine development of VIDA's novel lung nodule segmentation algorithm for solid and non-solid nodules using the standardized lung cancer LDCT screening protocol. Automated nodule segmentation in CT scans is challenging due to border ambiguity with neighboring structures (such as vessels and the pleura), poor boundary contrast of more subtle nodules, and noise associated with LDCT. The study team will develop a novel method that robustly segments pulmonary lesions by allowing mutual interaction between the nodules and surrounding structures, leading to a highly accurate segmentation with less manual corrective actions for a high volume lung cancer screening workflow.

Quantitative Lung Cancer Screening

Precision, Pulmonary Disease Evaluation and Lung Cancer Detection Using Quantitative Low-dose CT

Segmental airway branch differences will be measured by comparing the clinical low dose chest CT scan and the standard dose chest CT scan.

Vida Diagnostics, Inc

Jessica Sieren

Assistant Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impacts of Different Pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery	NCT02600481	Prostatic Neopl... Urinary Bladder...	low-pressure pn... standard-pressu...	18 Years - 80 Years	Huadong Hospital
Impacts of Different Pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery	NCT02600481	Prostatic Neopl... Urinary Bladder...	low-pressure pn... standard-pressu...	18 Years - 80 Years	Huadong Hospital
Lung Cancer Screening in a Population Exposed to Occupational Lung Carcinogens	NCT03562052	Lung Cancer		55 Years - 74 Years	Centre Hospitalier Intercommunal Creteil
Quantitative Lung Cancer Screening	NCT03622528	Pulmonary Disea... Chronic Obstruc... Cancer, Lung	Chest CT scan	50 Years - 74 Years	University of Iowa
Impacts of Different Pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery	NCT02600481	Prostatic Neopl... Urinary Bladder...	low-pressure pn... standard-pressu...	18 Years - 80 Years	Huadong Hospital

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