Digestive System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Intestinal Diseases

Adenoma

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

FIT and urine VOC samples followed by colonoscopy

Stool sample (FIT) analysed for blood in faeces and urine sample (VOC) analysed for the presence of volatile organic compounds

FIT and VOC

Chris J Bradley, MSc

Ramesh Arasaradnam, PhD

Chris Bradley, MSc

Helena Cox

Said Din, PhD

Nicola Lunt

Chris Smart

Diane Scalletta

Ravi Madhotra, PhD

Investigating people with bowel symptoms uses a test that detects traces of blood in the stools, the FIT test. There are many possible reasons for positive tests. A few people have cancer. However, most participants with symptoms don't have any serious bowel disease but have benign problems such as piles or irritable bowel syndrome (IBS). It is very difficult to diagnose on symptoms alone, those participants who have serious bowel disease and those who do not.

After a positive test, people are invited for colonoscopy - a sort of articulated tube that is passed up the bowel. Most people invited for colonoscopy don't have cancer. Only about 5% of those with positive FIT tests have cancer. About 25% have other bowel diseases, but most have nothing serious wrong at all. So they have the inconvenience and discomfort of colonoscopy but don't get any benefit from it.

The investigators want to try adding another test, the volatile organic compound (VOC) test, to see if the investigators can separate those with positive FIT tests who do have something wrong, from those who don't. The VOC test uses a urine sample. Using both tests might also be better for detecting cancer. FIT alone misses about 20%.

So the investigators think that using both tests might not only be better for detecting cancer, but also might mean that a lot of people will avoid having to have colonoscopy.

This study will recruit 1,819 participants with bowel symptoms from NHS trusts in the UK. They will provide stool samples for FIT and urine for VOC analysis. They will have colonoscopy to get a definite diagnosis. Then the investigators will look at their FIT and VOC test results to see if in future, people with both tests negative.

There is currently disparity between demand and available resources for colonoscopy. At present around 300,000 participants (and rising) are being referred annually to NHS trusts suspected of colorectal cancer (CRC). These participants are offered invasive colonic examinations (colonoscopy or CT colonography) but only 30% will have significant bowel disease. Significant bowel disease includes neoplasia (cancer and benign tumours) and significant treatable benign conditions such as inflammatory bowel disease and microscopic colitis. Of the remaining 70%, 40% have completely normal colonic investigations and 30% have functional bowel conditions such as irritable bowel syndrome or diverticular disease.

Set against this there is and will remain for the foreseeable future a capacity shortfall for colonoscopy. This limits the ability of the NHS to extend colorectal cancer detection within the Bowel Cancer Screening Programme (BCSP) or to target those participants that present for the first time through the Emergency Department (25% of all colorectal cancer diagnoses).

The increasing demand, limited capacity and lack of a triage tests have left NHS trusts with a conundrum of how best to stratify those with symptoms and at risk of SBD including CRC. The National Institute for Health and Care Excellence (NICE) has recommended a stool test (faecal immunochemical testing for haemoglobin, known as FIT) in the assessment of those suspected of CRC. NICE have recommended 10 μgHb/g faeces as the cut off for investigation of people with low risk symptoms who, account for only 10% of those referred with suspected CRC. When applied to high risk symptom groups, FIT will miss a significant number of participants with CRC (\~10%) if used on its own at the threshold recommended by NICE (10 μgHb/g faeces). FIT will also miss a large number of significant potentially pre-cancerous polyps (\~40%). Early detection and removal of such polyps will reduce risk of CRC.

The Bowel Cancer Screening Programme (BCSP) has set a FIT cut off of \>120 μgHb/g faeces, compared to the NICE threshold of 10 μgHb/g faeces, but even at the lower threshold recommended by NICE some SBDs will be missed. Whilst a lower threshold might improve detection of SBD, it will increase the number of colonoscopies that find no abnormality. Consequently, the investigators have been investigating a urine test (in addition to FIT) to improve detection of participants with SBD with a view to reducing unnecessary colonoscopies. The urine test analyses volatile organic compounds (VOCs) that originate from the body and provides a chemical 'fingerprint' that is disease specific. Stool FIT and urine VOCs identify different biological characteristics of SBD - haemoglobin (as a marker of excess blood loss) versus metabolic response to inflammation. In a preliminary study of 562 participants, stool FIT on its own (at a threshold determined from the data) detected 80% of those with colorectal cancer. However, the addition of urine chemical testing improved this to 97%. The number of CRC cases missed by combined FIT and urine chemical testing is similar to that of colonoscopy, the current gold standard.

Reducing Colonoscopies in Patients Without Significant Bowel Disease

Sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of stool FIT plus urine VOC in detection of SBD, using colonoscopy histology findings.

Receiver operating characteristic (ROC) curve of stool FIT plus urine VOC in detection of SBD to optimise the detection threshold.

Calculation of potential number of colonoscopies avoided in those without SBD.

Cost calculation, Quality of life (EQ-5D-5L) and quality adjusted life years (QALY) associated with utility of each diagnostic strategy (stool FIT and urine VOC) will be assessed to create a model that will employ a multi-part structure, consisting of a decision tree to evaluate short-term cost and consequences accruing at the diagnosis stage followed by a state-transition model to capture the long-term (lifetime) outcomes associated with the diagnosed condition.

University of Warwick

University of Leeds

University of Manchester

University Hospitals Coventry and Warwickshire NHS Trust

Recurrence

Shenbai Granules: Hedyotis diffusa 10g, Sophorae flavescentis radix 4.5g, Codonopsis radix 7.5g, Atractylodis macrocephalae rhizoma 6g, Mume fructus 4.5g, Coptidis rhizoma 1.5g, Zingiberis rhizome praeparatum 3g, Coicis semen 10g.

Orally, 1 sachet once, diluted in 150-200 ml of boiling water, 2 times a day.

It contains 5% SBG content, and the remaining ingredients are flavoring agents, starch and coloring agents. It is the same with SBG in appearance, smell and dosage form.

Orally, 1 sachet once, diluted in 150-200 ml of boiling water, 2 times a day.

In the first year, the trial granules will be started after enrollment for 3 months; In the second year, the trial granules will be started in the first 3 months; Each participant should have completed 6 months of trial granules.

Shenbai Granules

Chen Yugen, PhD

This study evaluates Shenbai Granules in Prevention of Colorectal Adenomatous Polyp Recurrence After Colonoscopy.Half of participants will receive Shenbai Granules,while the other half will receive a placebo.

There is no internationally recognized standard treatment for the prevention of recurrence of colorectal adenomatous polyps.

Based on TCM,previous studies have found that Shenbai Granules can significantly reduce the recurrence and deterioration rate of colorectal adenomatous polyps,reduce the proliferation of tumor cells and promote apoptosis of tumor cells.

colorectal adenomatous polyp patients after colonoscopy under colonoscopy

A double-blind design is used in this study for the investigators and subjects. The blinding codes are separately sealed and stored by the independent third-party organization. Trial granules are randomly coded as subject unique identification codes, and used by each clinical site according to the assigned drug numbers and in the order of case enrollment. Clinical monitors and investigators must be blinded at all times.

A Randomized Clinical Trial of Shenbai Granules in Reducing Recurrence of Colorectal Adenoma

Clinical Evidence-based Evaluation of the Efficacy of Shenbai Granules in Preventing Recurrent Colorectal Adenomas After Polypectomy and Its Therapeutic Mechanism

The data supporting the findings of this study are restricted in availability due to patient confidentiality reasons.

The ratio of the number of patients with new adenoma detected by colonoscopy to the total number of cases in this group during follow-up.

The ratio of the number of patients with any polypoid lesions detected by colonoscopy to the total number of cases in this group during follow-up.

The ratio of the number of patients with high-risk adenomas detected by colonoscopy to the total number of cases in this group during follow-up.

The ratio of the number of patients with sessile serrated lesions detected by colonoscopy to the total number of cases in this group during follow-up.

Nanjing University of Chinese Medicine

Guangdong Provincial Hospital of Traditional Chinese Medicine

Shanghai University of Traditional Chinese Medicine

ShuGuang Hospital

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Changhai Hospital

Beijing Friendship Hospital

The First Affiliated Hospital with Nanjing Medical University

West China Hospital

Jiangsu Famous Medical Technology Co., Ltd.

Standard of care includes a written paper sheet that summarizes information about the colonoscopy procedure and bowel preparation.

The video call will be performed at a designated time with a GE educated nurse. The purpose of the video call is (i) to clarify the patient in person about the colonoscopy procedure (ii) efficiently prepare the patient for bowel preparation by; asking the patient about her/his medical condition, the indication for colonoscopy, medical history, current medical status and medications currently taken. The patient will be inquired, whether she/he went through colonoscopy in the past, what preparation methods were undertaken and what the outcome of the examination was. Based on the information collected during the conversation, the designated nurse performing the interview will tailor the method of bowel preparation for the patient in terms of kind of relaxant, adjustment of medication intake and dietary adjustments before the examination.

The video film will explain the colonoscopy procedure and the bowel preparation procedure, in layman's terms and in the patient's preferred language (Hebrew or Arabic).

A written hand out containing all information required for bowel preparation

Standard of care

Standard of care and in addition a video call with a professional nurse conducted via digital devices and a free software (Zoom video communication or What's app application)

Standard of care + Video call

Standard of care and in addition to a video call, an explanatory short video on bowel preparation (video film), streamed to the patient's mobile device or computer

Standard of care + Video call + Educational video film

Toni Ashqar, Dr.

Neta Tuvia, Dr.

This is a single blinded randomized controlled study. The main question of this study is whether better preparation by making full use of digital tools can increase patient compliance with the preparation methods for colonoscopy, and as a result improve bowel preparation quality and colonoscopy outcomes in a cost-effective manner.

Participants will randomly assigned to one of three colonoscopy preparation groups (i) a written hand out containing all information required for bowel preparation (standard care) (ii) standard care and in addition a video call with a professional nurse conducted via digital devices and a free software (Zoom video communication or What's app application) (iii) standard care and in addition to a video call as described above using an explanatory short video on bowel preparation (video film), streamed to the patient's mobile device or computer.

Adequate bowel preparation is crucial for a successful and effective colonoscopy examination. Nevertheless, poor bowel preparation in patients is common and may lead to a lower quality of the examination that means a reduction in the rate of cecum intubation and lower detection rate of early and advanced adenoma. Finally, poor bowel preparation can lead to an abruption of the examination.

Digital advancement has been made in the context of colonoscopy bowel preparation, however high quality studies are still needed Ziv Medical Centre (ZMC) is a 300 bed governmental hospital located in Safed, Northern Israel that serves a diverse population. The gastroenterology department carries out approximately 1300 colonoscopies per year. A rapid audit has shown that approximately 15% of colonoscopies are stopped and up to 40% are incomplete, partly as a result of sub-optimal preparation.

The aim of this study is to determine whether better preparation by making full use of digital tools can increase patient compliance with the preparation methods for colonoscopy, and as a result improve bowel preparation quality and colonoscopy outcomes in a cost-effective manner.

This single blinded randomized controlled trial compares the effectiveness of bowel preparation in participants randomly assigned to one of three colonoscopy preparation groups (i) a written hand out containing all information required for bowel preparation (standard care) (ii) standard care and in addition a video call with a professional nurse conducted via digital devices and a free software (Zoom video communication or What's app application) (iii) standard care and in addition to a video call as described above using an explanatory short video on bowel preparation (video film), streamed to the patient's mobile device or computer.

All patients included in the trial will receive standard care 10 days before the examination. Patients randomized to the groups with a video call or a video call + video film will be contacted by a nurse to determine an appointment to the 10th day before examination. Patients randomized to the study arm including an educational video film will be sent a link to the video film after the video call. On the day of the exam, during the examination, the medical doctor records an OBPS score as described. After the exam, the medical doctor will register whether the exam was complete, incomplete, stopped and whether hospitalization was needed. After the examination and recovery, all patients will receive a short satisfaction questionnaire.

Impact of Digital Tools on the Quality of Bowel Preparation for Colonoscopy

A standard method used to assess a patient's bowel preparation for colonoscopies. The bowel preparation score is a sum of a segmental score (right-colon, mid-colon and rectosigmoid-colon) and a fluid quantity score. The segmental score is quantified on a scale of 0 to 4, with; 0 indicating perfect cleansing, 1 indicating good cleansing, 2 indicating Fair cleansing, 3 indicating poor cleansing and 4 indicating inadequate cleansing. Overall fluid quantity is quantified on a scale of 0 to 2, with; 0 indicating no fluid in the colon and 2 indicating a large amount of fluid in the colon. Both the colon score and fluid score result in an overall score ranging from 0 to 14, with; 0 an Excellent cleansing quality and 14 indicates the worst cleansing quality. Estimations of the scores are made by the medical doctors during the exam and are fed into a commercial software that calculates the overall OBPS score.

Patients will be asked about various aspects of the preparation using likert scales- the scores for each question will be compared across groups. The questionaires will include several questions about demographic background such as education level and occupation.

The proportion of successfully completed colonoscopies will be quantified.

The proportional change in the annual cost of running the service will be calculated, taking into account costs (research nurse, cost of developing the video etc.) and saving (averted complications, failed colonoscopies requiring re-booking etc.)

Ziv Hospital

Dr. Toni Ashqar, Senior gastroenterologist

Liver Diseases

Liver Cirrhosis

Liver Neoplasms

Hepatic Insufficiency

Liver Failure

Gastrointestinal Diseases

Fibrosis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Anti-Infective Agents

Everolimus

Tacrolimus

Liver Extracts

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Standard immunosuppression protocol with Tacrolimus, maintaining trough levels between 6 and 12 ng/ml in the first month, in association with steroids (20 mg/day with subsequent weaning within 3 months after transplantation).

Administration of Everolimus in association with Tacrolimus and steroids.

Administration of Everolimus within 24 hours from the time of randomization (7 days from the time of transplantation) in association with Tacrolimus and steroids. The first dose level of the trough will be performed at day 7 after initiation of therapy. After the reaching an Everolimus trough level of \>5ng/ml (final target 6-12 ng/ml), there will be a gradual weaning of tacrolimus (bringing Tacrolimus blood levels \<5 ng/ml) with discontinuation of Tacrolimus within 30 days after transplantation when possible.

Umberto Cillo, MD

Laura Saracino, MSc

Michele Colledan, MD

Vittorio Corno, MD

Giorgio Rossi, MD

Paolo Reggiani, MD

Luciano De Carlis, MD

Jacopo Mangoni, MD

Laura Saracino, MBS

Giacomo Zanus, MD

Daniele Neri, MD

Patrizia Boccagni, MD

Francesco D'Amico, MD

Enrico Gringeri, MD

Alessandro Vitale, MD

Pasquale Bonsignore, MD

Paolo Feltracco, MD

Dino Sgarabotto, MD

Roberto Marchini, MD

Angelica Magrofuoco, CCTC

Salvatore Agnes, MD

Erida Nure, MD

Mauro Salizzoni, MD

Francesco Lupo, MD

Fabio Bresàdola, MD

Umberto Baccarani, MD

Safety and Efficacy of Everolimus in adult de novo liver transplant recipients.

This prospective study was designed to evaluate the feasibility and effectiveness of the use of Everolimus in the minimization and possible suspension of calcineurin inhibitors in adult liver transplant patients. The study will take into account a control group (standard immunosuppression with tacrolimus and steroids) after induction with anti-IL2 Antibodies.

Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study

Terapia Con Everolimus Nel Trapianto de Novo di Fegato: Uno Studio Multicentrico Randomizzato

Patients not requiring calcineurin inhibitors (CNI)

Impact of therapy on renal function, evaluated by creatinine clearance according to the Modification of Diet in Renal Disease (MDRD) Study.

Evaluation of common post Liver Transplantation Adverse Events:

wound healing, bone marrow depression, hyperlipidemia, proteinuria, diabetes mellitus, diagnosed hypertension, infections, levels of HCV.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reducing Colonoscopies in Patients Without Significant Bowel Disease	NCT04516785	Colorectal Canc... Colorectal Diso... Colorectal Aden... Colorectal Poly...	FIT and VOC	18 Years - 90 Years	University Hospitals Coventry and Warwickshire NHS Trust
A Randomized Clinical Trial of Shenbai Granules in Reducing Recurrence of Colorectal Adenoma	NCT03616444	Gastroenterolog...	Shenbai Granule...	18 Years - 70 Years	Jiangsu Famous Medical Technology Co., Ltd.
Impact of Digital Tools on the Quality of Bowel Preparation for Colonoscopy	NCT05734079	Colonoscopy	Standard of car... Standard of car... Standard of car...	18 Years -	Ziv Hospital
Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study	NCT01423708	Liver Failure Liver Diseases Liver Cirrhosis Liver Neoplasms	Everolimus	18 Years - 70 Years	Azienda Ospedaliera di Padova
Reducing Colonoscopies in Patients Without Significant Bowel Disease	NCT04516785	Colorectal Canc... Colorectal Diso... Colorectal Aden... Colorectal Poly...	FIT and VOC	18 Years - 90 Years	University Hospitals Coventry and Warwickshire NHS Trust
Impact of Digital Tools on the Quality of Bowel Preparation for Colonoscopy	NCT05734079	Colonoscopy	Standard of car... Standard of car... Standard of car...	18 Years -	Ziv Hospital
A Randomized Clinical Trial of Shenbai Granules in Reducing Recurrence of Colorectal Adenoma	NCT03616444	Gastroenterolog...	Shenbai Granule...	18 Years - 70 Years	Jiangsu Famous Medical Technology Co., Ltd.
Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study	NCT01423708	Liver Failure Liver Diseases Liver Cirrhosis Liver Neoplasms	Everolimus	18 Years - 70 Years	Azienda Ospedaliera di Padova
Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study	NCT01423708	Liver Failure Liver Diseases Liver Cirrhosis Liver Neoplasms	Everolimus	18 Years - 70 Years	Azienda Ospedaliera di Padova

Spots Global Cancer Trial Database for gastroenterology