Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients screened positive for cardiopulmonary disease and having a medical (pulmonary and/or cardiology) visit preoperatively, but randomized to standard follow-up

Patients screened positive for cardiopulmonary disease and having a medical (pulmonary and/or cardiology) visit preoperatively, but randomized to structured medical follow-up after operation

Patients in the intervention arm are seen by a physician on the 4th or 5th postoperative day before discharge to pick up and manage any medical problems, and are furthermore seen in the cardiology clinic 1 month after operation, and in the pulmonary medicine clinic 1 and 3 months after operation

Structured medical follow-up after operation

Hans B Rahr, MD DMSc

More than one third of patients with colorectal cancer (CRC) suffer from comorbidity such as heart and lung diseases. This comorbidity markedly impairs survival after surgical treatment owing to increased mortality within the first weeks to months after surgery. Since the operation itself constitutes a severe challenge to the patient's cardiopulmonary system, this study aims to elucidate whether a more systematic perioperative management and follow-up of colorectal cancer patients with cardiopulmonary comorbidity may improve their outcome as measured by complications, hospitalisation times, and survival.

Background and overview

More than one third of patients with colorectal cancer (CRC) suffer from comorbidity such as heart and lung diseases. This comorbidity markedly impairs survival after surgical treatment owing to increased mortality within the first weeks to months after surgery, and this increased mortality is related to medical complications such as heart and lung complications. Since the operation itself constitutes a severe challenge to the patient's cardiopulmonary system, this study aims to elucidate whether a more systematic perioperative management and follow-up of colorectal cancer patients with cardiopulmonary comorbidity may improve their outcome as measured by complications, hospitalisation times, and survival within the first year.

All patients scheduled for elective surgical treatment of colorectal cancer at Vejle Hospital are screened by a study nurse for cardiopulmonary comorbidity to determine their eligibility for inclusion. If they fulfil inclusion criteria, they are seen preoperatively by a cardiologist and/or a pulmonary physician and undergo echocardiography and/or spirometry.

Included patients are randomized postoperatively to either standard follow-up alone ("standard" group) or standard follow-up supplemented with structured medical management and follow-up ("intervention" group). Patients in the intervention group are examined on the 4th or 5th postoperative day by an experienced physician from the Department of Internal Medicine. Furthermore, the intervention group is followed up at outpatient visits 1 and 3 months postoperatively. The 1-month visit includes a cardiology visit with echocardiography and ECG, and a pulmonary medicine visit with spirometry. The 3-month visit includes only a pulmonary medicine visit with spirometry.

Mortality, cardiopulmonary complications, hospitalisation time and treatment changes induced by the structured follow-up will be recorded as outcome measures for the intervention.

Hypothesis

Patients with cardiopulmonary comorbidity who have their standard follow-up extended to include a structured medical management and follow-up after surgery for colorectal cancer obtain a better outcome as measured by less cardiopulmonary morbidity and better survival within the first year.

Aim

To test a study design with systematic preoperative screening for cardiopulmonary comorbidity and postoperative randomization of eligible patients to either standard followup alone or standard follow-up supplemented with structured medical management and follow-up after operation for colorectal cancer.

Design

A randomized feasibility study. Based on older data, it will require approximately 400 patients in each arm to demonstrate a 10 % reduction in the expected mortality. This study aims to test the design and acquire more reliable mortality data in each arm in order to establish the basis for a larger multicentre study.

Screening and Systematic Follow-up for Cardiopulmonary Comorbidity in Patients Having Surgery for Colorectal Cancer

Incidence of intercurrent or present medical complications as described in Outcome 3. Judgement whether the complication was 1. already identified and optimally managed by others, 2. identified but not optimally managed, or 3. was undisclosed until the medical visit. Any interventions by the visiting physician graded (no intervention, change in medication, unplanned outpatient visit, admission to hospital as inpatient)

Incidence of postoperative medical complications as classified in the Danish national bowel cancer database (stroke, ACS, aspiration, pneumonia, heart failure, arrhythmia, pulmonary embolism, lung failure, renal failure, sepsis, deep vein thrombosis, arterial embolism, other) and graded according to Clavien. Particular focus on cardiopulmonary complications

Vejle Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Chia-Lin Hsu

Chien-Tai Hsu

Kuan-Yu Chen, PHD

Kuan-Yu Chen, PhD

The investigators hypothesize that the age-adjusted telomere length in lung cancer patients before chemotherapy may be correlated to comorbidity status and predict outcome. The change of telomere length shortening after chemotherapy may relate to treatment side effect and treatment response.

Except chemotherapy, telomere shortening were also related to a variety of cellular stress, including hydrogen peroxide, UV, and x-irradiation, transforming growth factor-beta, overexpression of oncogenes such as Ha-Ras. The cellular stress induced telomere shortening and/or telomere dysfunction and promote accelerated senescence in normal and malignant cells. Oxidative stress, which presented in several chronic inflammatory diseases, such as atherosclerosis, coronary artery disease, and chronic obstructive airway disease, was also found to be correlated with telomere shortening.

The Roles of Age, Comorbidity, and Telomere Length in Lung Cancer Treatment and Prognosis

The clinical data, including age, gender, clinical presentation, performance status, disease stage at diagnosis, initial treatment modality, progression-free survival of initial treatment, and survival duration will be recorded. Blood sample collection, quality of life, and cognitive function assessment will be performed before chemotherapy, one and four weeks after initial chemotherapy for telomere length measurement. Telomere length is measured by quantitative polymerase chain reaction(qPCR). Patients' characteristics are compared with chi-square test. Progression-free survival and survival time are analyzed by Kaplan-Meier with log rank test.

National Taiwan University Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Patient with (Group A) any Grade 3 (and over) Clavien-Dindo grading complication rate (30dC and 90dC)

Patient without (Group B) any Grade 3 (and over) Clavien-Dindo grading complication rate (30dC and 90dC)

Fabien SAINT, Pr

fabien saint, Pr

Clinician and the multidisciplinary team meeting in oncologic urology (MMO) play a key-role in the decision making. An unexplained surgeon attributable variance, probably linked to the subjective "eyeball test" effect, was identified as a strongest factor underlying non-compliance with guide line recommendations in the management of bladder cancer. So high-quality studies that identify barriers and modulators (such as comorbidities) of provider-level adoption of guidelines and how comorbidities are associated in making therapeutic choice and their impact in bladder cancer specific survival and overall survival, are crucial. To identify patients at high risk of early death, and to improve specific guideline for treatment might be decisive.

In order to assess survival, where mortality events compete, it will be more appropriate to compute a Cumulative Incidence Function (namely CIF). The investigators will compare outcomes across patient populations to obtain information to improve clinical decision-making. Such learning will be done through the use of neural networks or by applying population-based approaches, such as Genetic Algorithms (GA), Ant Colony Systems (ACS) and Particle Swarm Optimization (PSO), using as a four-stage based approach.

First, the investigators propose a "pretopology space" in order to study a dynamic phenomenon. Second, the investigators recall that the K-means approach remains one of the most used approaches for classifying a set of elements (patients / persons / others) into K (disjunctive) clusters. Third, the investigators propose a learning pretopology space for enhancing the clustering. Such an approach can be assimilated in spirit to one applied with high success on deep learning. Fourth and last, the investigators propose a reactive method that is able to include some new elements or remove some contained elements

Impact of COMORBIDities After Radical Cystectomy Using a Predictive Method With Artificial Intelligence

Evaluation of the Impact of COMORBIDities on Morbidity and Mortality After Radical Cystectomy for Cancer Using a Predictive Method With Artificial Intelligence

After retrieving associated comorbidities, any Grade 3, and over, Clavien-Dindo grading system complication rate (30dC and 90dC), information on primary treatment for bladder cancer (urothelial type and pT1 to pT4), outcome, time and cause of death, by our technician (from medical files of specific support centers), the primary objectives will be to model incorporation of comorbidities in making therapeutic choice, to improve care for patients with bladder cancer and specific guideline for treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Screening and Systematic Follow-up for Cardiopulmonary Comorbidity in Patients Having Surgery for Colorectal Cancer	NCT02328365	Colorectal Canc...	Structured medi...	18 Years -	Vejle Hospital
The Roles of Age, Comorbidity, and Telomere Length in Lung Cancer Treatment and Prognosis	NCT01963533	Lung Cancer		20 Years -	National Taiwan University Hospital
Impact of COMORBIDities After Radical Cystectomy Using a Predictive Method With Artificial Intelligence	NCT05204186	Bladder Cancer Comorbidity Deep Learning		18 Years -	Centre Hospitalier Universitaire, Amiens
The Roles of Age, Comorbidity, and Telomere Length in Lung Cancer Treatment and Prognosis	NCT01963533	Lung Cancer		20 Years -	National Taiwan University Hospital

Spots Global Cancer Trial Database for comorbidity

Every month we try and update this database with for comorbidity 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 comorbidity

Every month we try and update this database with for comorbidity 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 comorbidity 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.