Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Optional

In pre-training:

Biopsy performed during the digestive surgery procedure

Final evaluation (minimum 1 day and maximum 7 days after the last training session): biopsy performed in the digestive surgery department.

Muscle biopsies

3 sessions per week for 18 weeks. Duration: 1 hour Training on different strength training machines for the main muscle groups of the lower and upper limbs. The training load will be gradually increased over the sessions.

Muscle Strengthening

fasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls

Blood and urine samples

3 sessions per week for 18 weeks. Duration: 1 hour Training on a "classic" pedal bicycle (called an ergocycle). The intensity and duration of the training will be gradually increased over the sessions and according to the patient's abilities.

Aerobic Training

Carried out at least 15 days before surgery

1. st visit:

   * Nutritional assessment
   * Body composition
   * Psychometric tests of quality of life + IPAQ Test
   * VO2pic
2. nd visit:

   * Neuromuscular tests
   * Functional tests

Evaluation 1 pre-surgery

1. st visit:

   * Body composition
   * Nutritional assessment
   * Psychometric tests of quality of life
2. nd visit:

   * neuromuscular tests
   * Functional tests
   * Familiarization with training equipment if patient participates in re-training

Evaluation 2 post-surgery

performed 9 weeks after the beginning of training Identical tests to evaluation 1 + TM6

Intermediate Evaluation 3

Final post-training evaluation 4

Anaïs GOUTERON

Vanessa COTTET

Colon cancer is a real public health problem with more than 46,000 new cases diagnosed per year in France and about 650 cases in Burgundy. Muscle deconditioning (MD), which is characterized by a loss of muscle mass and function, is a frequent consequence in cancer patients and conditions the prognosis. Therefore, it is essential to understand its complex etiology in oncology in order to address the real need for therapeutic countermeasures in clinical practice. DM is a multifactorial process that is exacerbated by therapies. It induces neurogenic and muscular alterations that can profoundly affect patients' quality of life.

Currently, analyses of this phenomenon in oncology have been limited essentially to a global evaluation of physical performance, neglecting the muscular and nervous nature of the adaptations responsible for it.

Most studies analyzing the therapeutic effects of physical activity (PA) have shown numerous physiological and psychological benefits of aerobic exercise. However, this form of PA is still not very effective in preserving muscle mass.

Only muscle strengthening can have an anabolic effect by accelerating the rate of protein synthesis.

Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: an APA Muscle Rendorcement Program

Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: A Pilot Study of an APA Muscle Rendorcement Program

Tolerance in terms of level of effort and pain will be tested at each session and will condition the continuation or not of the sessions and therefore acceptability

Centre Hospitalier Universitaire Dijon

Symptoms and General Pathology

Liver Cirrhosis

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Liver Diseases

Hematinics

Liver Extracts

All 3000 patients recruited to the Pearl study

The samples will be used to identify a range of tests (including genetic, protein and other biomarkers), which along with the clinical data will hopefully identify those most at risk of developing HCC, and to identify HCC at the earliest possible time points.

Blood and Urine samples

Study Coordinator

Eleanor Barnes, Prof

Ellie Barnes

This study aims to recruit 3000 people with liver cirrhosis into a Prospective cohort for early detection of Liver cancer - the Pearl cohort. The study team believe that using a combination of novel tests may improve the detection of early Hepatocellular Carcinoma (HCC).

During a four-year follow-up period, around 100 Pearl patients are expected to be diagnosed with HCC. Blood, urine, clinical and imaging data will be collected over the follow up period. The samples will be used to identify a range of tests (including genetic, protein and other biomarkers), which along with the clinical data will hopefully identify those most at risk of developing HCC, and to identify HCC at the earliest possible time points.

Prospective Cohort for Early Detection of Liver Cancer

Diagnostic approaches to be tested will include:

1. detection of epigenetic (e.g. methylation profiling) and genetic mutations, and copy number variations in circulating tumour DNA;
2. multiparametric MRI liver imaging including MR biomarkers of inflammation, fibrosis, fat and iron content;
3. host genetic makeup (relevant variants identified through Genome Wide Association Studies);
4. detection of autoantibodies to tumour associated antigens;
5. epitope mapping of circulating antibody repertoire using random peptide libraries;
6. protein biomarkers including the L3 isoform of alphafetoprotein, and des-gammacarboxy- prothrombin;
7. proteomic and metabolomic profiling, including steroid metabolic signatures in urine.

The Harrell's Concordance Index (C-index) will be calculated for each biomarker/model of interest. The minimum and maximum C-index scores are 0 and 1, respectively, where the higher the score the better the biomarker/model is at identifying HCC risk. C-index values indicate the degree to which individuals who develop HCC have a higher risk score than those who do not. C-index values will be adapted to incorporate non-HCC mortality as a competing risk. The C-index value will be used to identify the biomarkers/models with the best discriminative ability.

Cumulative incidence of HCC according to cirrhosis aetiology

Cancer Research UK

Roche Diagnostic Ltd.

OncImmune Ltd

Perspectum

University of Nottingham

Glasgow Caledonian University

University of Oxford

Nervous System Diseases

Gland and Hormone Related Diseases

Brain Neoplasms

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Hypothalamic Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Patients will be i.v. injected with approximately 5 mCi (\~3.4-6.7 nanomoles) of 89Zr-DFO-cRGDY-PEG-Cy5-C' dots (specific activity range 750.0 - 1450 mCi/ µmol) and undergo the microdosing study for purposes of collecting particle tracer kinetic and dosimetry data. The patient's PET/CT Brain scans may be acquired prior to surgery. All non-surgical and some surgical patients (at the discretion of the physician) will undergo PET brain imaging.

Before the patient's PET Brain scans patients will be i.v. injected with approximately 5 mCi (\~3.4-6.7 nanomoles) of 89Zr-DFO-cRGDY-PEG-Cy5-C' dots (specific activity range 750.0 - 1450 mCi/ µmol) and undergo the microdosing study for purposes of collecting particle tracer kinetic and dosimetry data. All non-surgical and some surgical patients (at the discretion of the physician) will undergo PET brain imaging

A low dose spiral CT is performed first per the standard procedure. These images will be used for both attenuation correction and registration of the serial image set. The initial PET brain scan will be acquired up to about 24 hours post injection. Based upon the discretion of the physician, non-surgical patients have the possibility of a second scan and third up to about 48 hours post injection. The times per bed position may be adjusted after the first patient is imaged, and his/her scans evaluated. Additional low dose CT scans will be performed at the image session for attenuation correction and image registration. PET study may be done on a PET-MR scanner for ease.

89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging

Venous blood and urine samples will be obtained at approximately 0.5 hours post injection at the end of each scan

Nelson Moss, MD

The purpose of this study is to test if PET scans using 89Zr-DFO-cRGDY-PEG-Cy5-C' dot particles, can be used to take pictures of brain tumors. The investigators want to understand how the particles are distributed and removed from the body, which may help others be treated in the future. This will be the first time that 89Zr-DFO-cRGDY-PEG-Cy5-C' dot particles are being used in people. The amount of particles given in this study is very small compared to the amount that was used in mice animal studies.

This is a two-year microdosing study that will enroll up to 10 surgical or non-surgical patients harboring pituitary adenomas, high grade gliomas or metastatic brain tumors.

Two expert PET scan readers, who are board-certified in Nuclear Medicine, will be designated to read and evaluate PET-CT scans. Volumetric region-of-interest analysis and extraction of the mean and maximum standard uptake values (SUVs) will be provided. Both readers will initially be blinded to the patient's clinical information for scan interpretation. A second interpretation will then be performed after both readers are provided with clinical information about the primary tumor site.

A First in Human Study Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers for Malignant Brain Tumors

Imaging of Patients With Malignant Brain Tumors Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers: A Phase 1 Microdosing Study

using serial PET imaging and/or correlative histologyFollowing tumor biopsy or surgical resection, histologic assessments will be performed using autoradiography to visualize the distribution of this agent within tumor tissue specimens.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: an APA Muscle Rendorcement Program	NCT05099211	Colon Cancer Muscle Strength...	Muscle biopsies Muscle Strength... Blood and urine... Aerobic Trainin... Evaluation 1 pr... Evaluation 2 po... Intermediate Ev... Final post-trai...	18 Years - 80 Years	Centre Hospitalier Universitaire Dijon
Prospective Cohort for Early Detection of Liver Cancer	NCT05541601	Cirrhosis Hepatocellular ...	Blood and Urine...	18 Years - 100 Years	University of Oxford
Prospective Cohort for Early Detection of Liver Cancer	NCT05541601	Cirrhosis Hepatocellular ...	Blood and Urine...	18 Years - 100 Years	University of Oxford
A First in Human Study Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers for Malignant Brain Tumors	NCT03465618	Brain Cancer Pituitary Adeno...	89Zr-DFO-cRGDY-... Blood and Urine...	18 Years -	Memorial Sloan Kettering Cancer Center
Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: an APA Muscle Rendorcement Program	NCT05099211	Colon Cancer Muscle Strength...	Muscle biopsies Muscle Strength... Blood and urine... Aerobic Trainin... Evaluation 1 pr... Evaluation 2 po... Intermediate Ev... Final post-trai...	18 Years - 80 Years	Centre Hospitalier Universitaire Dijon
Prospective Cohort for Early Detection of Liver Cancer	NCT05541601	Cirrhosis Hepatocellular ...	Blood and Urine...	18 Years - 100 Years	University of Oxford

Spots Global Cancer Trial Database for blood and urine samples