Neoplasms

All Conditions

Heart and Blood Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Thrombosis

Venous Thrombosis

Carcinoma, Renal Cell

Kidney Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Embolism

Embolism and Thrombosis

Vascular Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Surgery planification with the combination of all the images available and a 3D biomodel printed from that images.

Surgery planification with all the images available

To perform a surgery planification with the combination of the images available and the 3D biomodel in terms of: anticipation of potential complications and the human resources and necessary materials

3D printing + images

To perform a surgery planification with the images available in terms of: anticipation of potential complications and the human resources and necessary materials

Images

Inés Rivero Belenchón

María Aguilar Rodriguez

Victoria Gomez Dos Santos

Laura Illana Reyero

Francisco Javier Burgos Revilla

Ines Rivero Belenchon

María Aguilar Rodríguez

Carmen Belén Congregado Ruíz

Carmen Belén Congregado Ruíz, FEA

Objectives:

Apply 3D- printed biomodels in patients with renal cancer (RCa) and vascular involvement (VTT) to: (1) improve surgical planning, (2) upgrade surgical results, (3) facilitate communication with patients, (4) serve as a model for teaching residents and (5) shortening the learning curve in experienced urologists.

Methodology:

The design of the study is a randomized clinical trial, to determine the safety, precision, feasibility, predictability, efficacy and efficiency of a surgical strategy based on imaging tests and 3D models regarding the surgical planning in patients with RCa and VTT. This is a longitudinal, prospective, experimental and multicenter study on a cohort diagnosed of RCa and VTT from 2018 in the Virgen del Rocío University Hospital (HUVR) or in the Ramón y Cajal University Hospital (HURC). The study will last for 3 years and will be carried out jointly by the HUVR, the HURC and the IBIS, in a multidisciplinary team made up of urologists, radiologists and engineers.

Phase 1, obtaining the 3D printed biomodel and study of feasibility.

Distribution of tasks: Conducted jointly by:

* Radiology team of the HUVR: Segmentation and 3D virtual reconstruction of the image tests. Compare measurements with image tests.
* IBIS / HUVR engineering team. Design and development of specific segmentation algorithm for the tissue selection of interest. Modeling of image and printing of the 3D model.
* Urology team of the HUVR. Identification of anatomical structures and taking measurements in the 3D model. Simulation of surgery following the surgical guide.
* Production center: It will be carried out entirely in the HUVR.
* Process: custom and manufacture 3D models to perform a surgical simulation using imaging tests of operated patients, with different characteristics until achieving an optimum prototype. Different anatomical structures will be measured and compared in the model and in the image (Collection sheet of data). Later, we will check if it is possible to perform a surgical simulation on the model reproducing in it each of the steps necessary to perform the surgery (surgical guide, annex 3).

Phase 2, precision and predictability study:

Distribution of tasks: Conducted jointly by:

* HUVR radiology team and HURC radiology team. Segmentation and 3D virtual reconstruction of the image tests. Taking measurements in image tests.
* IBIS / HUVR engineering team. 3D model printing.
* HUVR urology team and urology team HURC. Taking measurements in the 3D model. Surgical planning with imaging tests or with imaging tests and 3D model (simulation following the surgical guide).

Real surgery and taking measurements in real surgery.

* Production center: 3D printing in the HUVR, precision and predictability study, HUVR and HURC.
* Process: all patients diagnosed with CaR and TTV in the HUVR and HURC will be recruited between the years 2018 and 2021 and will be randomized into two groups. In the control group the surgical planning will be based exclusively on image tests. In the intervention group we will carry out a surgical planning based on imaging tests and the 3D model (on which we will perform a surgical simulation following the guide surgical). Subsequently, the surgery will be carried out, and in each of the groups it will be compared (Gold Standard) with the pre-surgical planning performed.
* precision study Anatomical measurements will be taken before the surgical intervention in the image models, in the 3D model and subsequently in vivo during surgery
* predictability study A prediction will be made of the type of surgery to be performed, the complications, and the necessary human and material resources.

Phase 3, efficacy and efficiency study:

* HUVR urology team and urology team HURC. Data Collect.
* Process: We will check if a surgical planning with image tests and 3D model makes the surgery more effective and efficient than the one based exclusively on imaging tests. Efficacy, will be defined as the ability to achieve a good surgical result. Efficiency will be defined as the ability to obtain good results with the minimum possible costs and in the minimum possible time.

Phase 4, study of satisfaction level with surgical planning based on 3D model and learning curve of urologists:

* HUVR Urology team and HURC urology team: Delivery of satisfaction surveys and data collection.
* HUVR urology team: Comparison of learning curves.

Final phase, analysis of the results and dissemination plan.

- All researchers: the results of the different tasks carried out in the project will be evaluated and scientific publications and communications in national and international congresses will be made.

Study model: Longitudinal, prospective, experimental, multi centric on a cohort of patients diagnosed of Renal Cell Carcinoma with Vascular Involvement from 2018 in either the HUVR or the HURC

3D-biomodels for Surgical Planning in Patients With Renal Cancer and Vascular Involvement

All IPD that underlie results in a publication will be shared, as well as the study protocol, the Statistical Analysis Plan, the Informed Consent Form and the Clinical Study Report

The grade of concordance between the CT and 3D model will be assessed firstly identifying all the anatomical structures in the 3D model: Kidneys, tumor, arteries and veins.Then some measures will be taken both in the CT and the model to compare them. That will be repeated in 20 cases and the grade of concordance will be assessed by using the Kappa and the intraclass correlation coefficient.

The grade of concordance between the CT and/or 3D model and the "vivo" will be assessed firstly identifying all the anatomical structures in the CT or 3D and the vivo when the surgery is performed: Kidneys, tumor, arteries and veins.Then some measures will be taken both in the CT and or 3D and the vivo during the surgery to compare them. The grade of concordance will be assessed by using the Kappa and the intraclass correlation coefficient.

A pre-surgery planning will be made to predict the kind of surgery, the potential complications and the human and material necessary resources for the surgery. Both predictions (the one made only with images, and the one made with images and 3D) will be compared with the reality (the surgery). The grade of concordance between the prediction and the reality will be assessed using the Kappa and the intraclass correlation coefficient.

We will compare the surgery outcomes between the surgery pre-planned with images and the one pre-planned with 3D and images. That will be assessed in terms of blood transfusion (number of blood transfusiones needed)

We will compare the surgery outcomes between the surgery pre-planned with images and the one pre-planned with 3D and images. That will be assessed in terms of number and grade of complications following the Clavien's scale.

We will compare the surgery outcomes between the surgery pre-planned with images and the one pre-planned with 3D and images. That will be assessed in terms of free surgery margins according to the histopathology analysis of the specimen (yes/no)

We will compare the surgery outcomes between the surgery pre-planned with images and the one pre-planned with 3D and images. That will be assessed in terms of number of hospitalisation days

We will compare the surgery outcomes between the surgery pre-planned with images and the one pre-planned with 3D and images. That will be assessed in terms of necessity of stay in the Intensive Care Unit (yes/no)

Cost-effectiveness analysis, comparing the cost of the surgery with the 3D planning (sum of the impression, the surgery and the postoperative time) and the surgery performed with an image planning.

We will compare the learning curve of the surgeon that starts its training practicing in a 3D model and the one of a surgeon that did the learning curve without training in the 3D model

A questionnaire will be given to each patient in the consult after the explanation of the surgery with the 3D model (2 questionnaire published in DOI 10.1007/s00345-015-1632-2) In addition, at the end of the study, another satisfaction questionnaire will be given to all the urologists that participated in the study using a questionnaire already used (https://doi.org/10.1007/s00345-017-2126-1)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Behaviors and Mental Disorders

Behavior, Addictive

All Drugs and Chemicals

Nicotine

Subjects will receive messages including FDA-proposed LCC warnings and Images in 30% size. Participants will be contacted each day to invite them to complete the survey for that day of the study protocol.

Subjects will receive text messages including FDA-proposed LCC warnings. Participants will be contacted each day to invite them to complete the survey for that day of the study protocol.

Participants will be contacted each day to invite them to complete the survey for that day of the study protocol.

For six subsequent days (days 2-7) participants will be contacted and asked to complete a daily survey.

Survey

Participants will receive messages including FDA-proposed LCC warnings.

FDA-proposed Text messages

Participants will receive messages including images in 30% size.

Participants will receive messages including Surgeon General Text-only Warnings.

Surgeon General Text messages

Kristen Jarman

Leah Ranney, PhD, MA

This study explores the effect of the little cigars and cigarillos (LCC) warnings on youth who currently use, have ever used, or are susceptible to using LCCs, especially Black/African American youth. This study will inform the Food and Drug Administration (FDA) implementation of LCC warnings, which can reduce LCC use and lessen tobacco health disparities among youth.

Cigar use exposes youth to the addictive effects of nicotine during a critical developmental period and increases the risk of multiple cancers and premature death. Recent data indicate that cigars are the second most commonly used tobacco product by youth and that past 30-day cigar use is 7.6%, which translates into 1.1 million high school students. Of the three major types of cigars-large cigars, little cigars, and cigarillos-little cigars and cigarillos (LCCs) are the most commonly used in the US, particularly among younger people. LCC use also contributes to tobacco health disparities, as Black or African American youth use cigars more frequently than other youth. In 2016, the Food and Drug Administration (FDA) deemed LCCs subject to FDA regulation, requiring six rotating text-only warning statements to be on LCC packaging. Previous research has examined the effectiveness of LCC warnings in reducing youth willingness to use LCCs.

Research from studies of cigarette warnings suggests that effective LCC warnings should employ images that illustrate negative health effects associated with use and a larger warning label prominently displayed on the pack. Among youth, health warnings on cigarette packs that contain both text statements and images are more effective and engaging than text-only warnings. However, evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for three reasons: 1) there is no evidence on the effectiveness of the FDA-mandated text-only LCC warnings on behavioral intentions or other outcomes among youth 2)courts have ruled that effective tobacco warnings on one type of tobacco product cannot be used to justify warnings on other types of tobacco, and 3) LCC users have different demographic and consumption profiles than cigarette users include more Black/African Americans and use LCCs on fewer days per month.

At the beginning of the baseline survey (day 1), participants will first consent to participate in the study and then complete a questionnaire about their LCC use and susceptibility, exposure to cigar advertising and warnings, and demographic characteristics, in addition to other measures. At the end of the baseline questionnaire, survey software will randomly assign participants to one of the 3 study conditions.

Little Cigar and Cigarillo Warnings for Youth

Strengthening Little Cigar and Cigarillo Warnings to Prevent Adolescent Use

The average willingness to use score will be measured by the average of the responses to the 2 survey questions scores. Question Scoring is on a scale of 1 to 5, where 1 indicates low willingness to use LCCs, and 5 indicates a willingness to use LCCs score.

Past 7 days little cigar use will be measured with separate items for cigarillo and little cigar use by the survey.

Past 7 days cigarillos use will be measured with separate items for cigarillo and little cigar use by survey.

little cigar cigarillo (LCC) susceptibility will be measured with 3 items by survey.

Cognitive elaboration about dangers will be measured by the survey.

Cigar appeal will be measured by the survey.

Warning relevance will be measured by the survey.

Warning negative affect/worry will be measured by the survey.

Past 7 day little cigar cigarillos (LCCs) use will be measured by the survey.

Knowledge of LCC harms will be measured by 13 items the survey.

Beliefs about little cigar cigarillo (LCC) harms will be measured with 10 items by survey.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
3D-biomodels for Surgical Planning in Patients With Renal Cancer and Vascular Involvement	NCT03738488	Renal Cell Carc... Three-Dimension... Venous Thrombos...	3D printing + i... Images	14 Years -	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Little Cigar and Cigarillo Warnings for Youth	NCT06413797	Little Cigars a...	Survey FDA-proposed Te... Images Surgeon General...	15 Years - 20 Years	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for images

Every month we try and update this database with for images cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for images

Every month we try and update this database with for images cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for images cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.