14 patient with right-sided colon cancer receive intervention before the hemicolectomi.
both arms of this study use the same intervention.

14 patient with right-sided colon adenoma receive intervention before the endoscopic mucosa resection.
both arms of this study use the same intervention.

Right-sided Colon Cancer

Right-sided Colon Adenoma

therapeutic endoscopy where the two drugs: metronidazole and fosfomycin disodium are sprayed through out the right colon section (from caecum to right colon flexure). This intervention is going to be performed on patients in both track 1 and track 2a.

therapeutic endoscopy with metronidazole and fosfomycin disodium

Department of Surgery, Herlev Hospital

Department of Surgery, Zealand University Hospital

Preoperative Endoscopic Treatment With Fosfomycin and Metronidazole in Patients With Right-sided Colon Cancer and Colon Adenoma (MEFO-trial)

Preoperative Endoscopic Treatment With Fosfomycin and Metronidazole in Patients With Right-sided Colon Cancer and Colon Adenoma: a Clinical Proof-of-concept Intervention Study MEFO Trial

A quantitative change in the bacterial biofilm adherent to the colonic epithelium of the resected colon adjusted for baseline level found before the intervention through fluorescence in situ (FISH) technique. The specific measurement variable is biofilm depth in μm. The method of aggregation will be means.

A quantitative change in the bacterial biomass adherent to the colonic epithelium of the resected colon adjusted for baseline level found before the intervention through fluorescence in situ (FISH) technique. The specific measurement variable is biofilm mass in ng/cm^2. The method of aggregation will be means.

- The determination of differences in translational markers present in the resected tumor tissue adjusted for the level seen at the baseline (the therapeutic colonoscopy) through a principal component analysis (PCA). The translational markers of interest are tumor markers, markers of the microenvironment and the immune response. The analyses will be performed using the PanCancer IO 360TM Gene Expression Panel (nanoString).

- The determination of a change in the bacterial composition adjusted for the bacteria found at baseline before the intervention through fluorescence in situ (FISH) technique and sequencing with Metagenome.

Differences in the presence of known bacterial drivers such as Fusobacterium nucleatum, Enterococcus faecalis, Bacteroides Fragilis, Escherischia coli, and Porphyromonas in the tumor samples from preoperative biopsies and the resected colon.

Differences in gene expression in the normal mucosa from preoperative biopsies and the resected colon using the PanCancer IO 360TM Gene Expression Panel (nanoString).

Differences in gene expression in the preoperative and operative blood samples determined by the nCounter® PanCancer Immune Profiling Panel (nanoString).

Assessment of the immunological response using immunoscore. A binary outcome of either high or low immunoscore

The pathological assessment of tumor: tumor type, grade of dysplasia, TNVM-stage, MSI- status.

A microbiological assessment of the biofilm present on the tumor in track 1. This will be reported as a binary outcome.

The pathological assessment of the normal mucosa of the right hemicolon: presence of biofilm, dysplasia and inflammation.

Safety assessment of the spraying of the right hemicolon with fosfomycin/metronidazole gel. This will be assessed through adverse events reported at least 19 days after the intervention (postoperative day 14).

Differences in gene expression in the normal mucosa from preoperative biopsies and the operative biopsies using the PanCancer IO 360TM Gene Expression Panel (nanoString).

Differences in gene expression in the tumor tissue from the mucosal resection compared with archived FFPE tumor tissue from patients with colon adenoma using the PanCancer IO 360TM Gene Expression Panel (nanoString).

Differences in gene expression in the preoperative blood samples and the blood samples taken on the operation day using the nCounter® PanCancer Immune Profiling Panel (nanoString).

The pathological assessment of polyp using the Paris Classification and the Lateral Spreading Tumor Classification to determine tumor type.

The pathological assessment of polyp: size

an assessment of the immunological response via immunoscore

The microbiological assessment of polyp: an assessment of the biofilm present on the polyp. This will be reported as a binary outcome.

Assessment of the spraying of the right hemicolon with fosfomycin/metronidazole gel. By collecting reported adverse events at least 19 days after the intervention (postoperative day 14).

Zealand University Hospital

Costerton Biofilm Center

Reponex Pharmaceuticals A/S

Region Zealand

The same intervention will apply to both arms of this study, the only difference is the patient group which receives the treatment.
In Clinical Trial, Track 1 and Track 2a will be registered as two different arms, but the results from each arm later on is going to be reported in separate publications.

Colorectal Adenoma

Colorectal Neoplasm

Colorectal Cancer

Obesity

Metabolic Syndrome

Non-Alcoholic Fatty Liver Disease

Liver Fibrosis

All patients would undergo colonoscopy as part of standard care. Patients recruited for this study would have their past medical history, family history, medication history, as well as waist circumference, BMI and blood pressure recorded. All patients would also have blood tests (described earlier) and a subset will undergo Fibroscan.

Colonoscopy

South Tyneside NHS Foundation Trust

County Durham and Darlington NHS Foundation Trust

Kettering General Hospitals NHS Foundation Trust

The Leeds Teaching Hospitals NHS Trust

South Tees Hospitals NHS Foundation Trust

Northumbria Healthcare NHS Foundation Trust

Newcastle Upon Tyne NHS Foundation Trust

North Tees and Hartlepool NHS Foundation Trust

CIty Hospitals Sunderland NHS Foundation Trust

ObeSity Related Colorectal Adenoma Risk

Development of a risk model for colorectal adenoma or CRC based upon risk factors identified

Number of patients with colorectal adenomas or CRC who have abnormal liver enzymes

Number of patients with colorectal adenomas or CRC who are obese, as measured by BMI or waist circumference

Number of patients with colorectal adenomas or CRC who have abnormal FIB4 score

Number of patients with colorectal adenomas or CRC who have abnormal Fibroscan readings

Number of patients with colorectal adenomas or CRC who are smokers or have high alcohol intake

South Tyneside and Sunderland NHS Foundation Trust

Newcastle-upon-Tyne Hospitals NHS Trust

City Hospitals Sunderland NHS Foundation Trust

Kettering General Hospital NHS Foundation Trust

Patients with resistant hypertension and chronic kidney disease (GFR between 15 and 60) will receive Renal Denervation as a treatment

Chronic Kidney Disease

The Symplicity Renal Denervation System is indicated for the delivery of low-level radiofrequency energy through the wall of the renal artery to denervate the kidney and reduce blood pressure in adult patients with refractory hypertension. The Symplicity Generator delivers controlled relatively low power radiofrequency energy (approximately 8 watts for 2 minutes). The Symplicity System selectively denervates the kidney by delivering radiofrequency from the generator via the electrode of the catheter through the renal artery wall from the intra-luminal side to ablate the renal sympathetic efferent and afferent nerves and reduce overall sympathetic nervous system activity.

Renal Denervation

Regina Qu'Appelle Health Region

Renal Denervation in Patients With Chronic Kidney Disease

Prairie Renal Denervation Study

measured using ATCOR machine: Augmentation index (%) Augmentation pressure (mm Hg) Central pulse pressure (mm Hg) Central systolic pressure (mm Hg) Central diastolic pressure (mm Hg) Pulse pressure amplification (mm Hg) Time to reflection (Tr) in ms Pulse Wave Velocity

Using an echocardiogram, the following cardiac measures will be taken:
Left ventricle volume Left ventricle hypertrophy Left ventricle function Left atrial mass E-wave velocity E-prime velocity

systolic and diastolic blood pressure (mm Hg) measured using BP-Tru machine.

systolic and diastolic blood pressure (mm Hg) measured using BP-Tru machine

For 24-hour blood pressure, we will record the following:
12-hour daytime Systolic Pressure (mm Hg) 12-hour daytime Diastolic Pressure (mm Hg) 12-hour nighttime Systolic Pressure (mm Hg) 12-hour nighttime Diastolic Pressure (mm Hg)

Saskatchewan Health Authority - Regina Area

~10 normocalcemic euthyroid patients (control tissue)

Parathyroid Adenoma and normal parathyroid gland

Primary Hyperparathyroidism (PHPT)

PGIMER

Regulation of Vitamin D Receptor (VDR),Calcium Sensing Receptor (CaSR), Cyclin D1,Ki67 and Proliferating Cell Nuclear Antigen (PCNA) in Primary Hyperparathyroidism

Transcriptional and Translational Regulation of Vitamin D Receptor (VDR) and Calcium Sensing Receptor (CaSR) in Patients With Sporadic Primary Hyperparathyroidism

adenoma/albumin

Preoperative Endoscopic Treatment With Fosfomycin and Metronidazole in Patients With Right-sided Colon Cancer and Colon Adenoma (MEFO-trial)

ObeSity Related Colorectal Adenoma Risk

Renal Denervation in Patients With Chronic Kidney Disease

Regulation of Vitamin D Receptor (VDR),Calcium Sensing Receptor (CaSR), Cyclin D1,Ki67 and Proliferating Cell Nuclear Antigen (PCNA) in Primary Hyperparathyroidism

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