Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Adenoma

Colonic Diseases

Colonic Polyps

Polyps

Gastrointestinal Diseases

Intestinal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Herbal and Botanical

All Drugs and Chemicals

Cola

Cancer of the colon and rectum is second only to lung cancer as the leading cause of cancer-related deaths in the United States.Each year, about 1.23 million new cases of bowel cancer are diagnosed worldwide, 333,000 in Europe alone. Colorectal cancer almost always starts in a benign growth called a polyp. Polyps originate in the inner lining of the colon, where they may be visible in a screening test known as colonoscopy. Recent research has shown that appropriate screening and treatment can alleviate much of the suffering associated with colorectal cancer and reduce the number of deaths caused by this malignancy

colonoscopy system (PeerScope B System™)

Ian Gralnek, Prof.

The PeerScope B System™ by PeerMedical Ltd. is intended to provide visualization (via a video monitor) and therapeutic access to the lower intestinal tract. The lower intestinal tract includes, but is not restricted to the organs, tissues and subsystems: large bowel and cecum. The device is introduced rectally, as with any standard colonoscope when indications consistent with the need for the procedure are observed in the adult patient population.

The purpose of this prospective clinical study is to establish the usability of the PeerScope B System™ when used during standard colonoscopy procedure.

The study population is comprised of patients indicated for colonoscopy.

The primary endpoint is reaching the cecum of the colon with PeerScope B System™.Secondary endpoints:

1. The first secondary endpoint is the incidence of complications using the PeerMedical colonoscope.
2. The second secondary endpoint is successful therapeutic interventions as biopsies, polypectomies, APC etc.
3. The third secondary endpoint is the procedure time.
4. The fourth secondary endpoint is the subjective evaluation of the additional view angle by the physician.
5. The fifth secondary endpoint is patient satisfactory.

Founded in 2009, PeerMedical develops colonoscopes capable of wide view angle at the press of the button. The PeerScope B System™ is an endoscopic platform that enables the physician to get a wide angle view while maintaining all of the features commonly used during Gastrointestinal (GI) procedures with very limited learning curve and in service process. The current standard devices have viewing limitations. By adding this viewing functionality, PeerMedical will potentially empower physicians to improve polyps detection and cancers within the colon.

PeerScope B System™ Clinical Protocol

a Prospective Clinical Study to Establish the Usability of the PeerScope B System™ When Used During Standard Colonoscopy Procedure

a full colonoscopy procedure is characterized by reaching an anatomical mark (cecum)at the end of the insertion phase and then the physician start the withdrawal screening phase

PeerMedical Ltd.

Recurrence

Disease Attributes

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Aspirin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Stanislas CHAUSSADE, MD

Experimental and epidemiologic studies have suggested that aspirin intake reduces the risk for colorectal cancer. In the APACC study we randomly assigned 291 patients to daily Aspirin or Placebo for 4 years. However, the available data are not sufficient to serve as the basis for firm recommendations

The APACC Study is a prospected, randomized, double-blind, placebo-controlled multicentre clinical trial design to test the efficacy of regular low-dose aspirin administration in reducing the recurrence rate of colorectal adenomatous polyps. The study involved 49 gastroenterology centers from various parts of France. Patients were eligible if they had either at least 3 adenomas irrespective of size, or at least one measuring 6mm in diameter or more histologically confirmed colorectal adenomatous polyp by the local pathologist, and 2 independent pathologists, underwent a complete colonoscopy with polypectomy and were then confirmed free of polyps, were aged between 18 and 75 years at recruitment, and were be able to conform to the protocol during the study period. During a 4-week run-in period before enrolment, all subjects took 300 mg aspirin per day to test tolerance and compliance with the treatment. They were then randomized to either of the following three groups: placebo, aspirin as acetylsalicylate of lysine 160 mg/day or aspirin as acetylsalicylate of lysine 300 mg/day. Information on compliance, tolerance of the treatment and concomitant disease is obtained at regular clinical visits every 4 months. Informations on factors such as smocking habits, previous medical history was recorded at enrollment. The primary outcomes were defined as the proportion of subjects in whom at least one new adenoma was detected, and the adenomatous polyp burden calculated as the sum of the diameters of these adenomas at the follow-up colonoscopy 1 and 4 years after enrollment.

APACC Study:Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence

Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence

Société Nationale Française de Gastroentérologie

Ministry of Health, France

Sanofi-Synthelabo

Assistance Publique - Hôpitaux de Paris

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Pathological Conditions, Anatomical

Intestinal Polyps

Glenn D Braunstein, MD

When the DNA inside of human cells undergoes certain alterations (mutations), the cells may develop into a cancer. The cancer cells may shed this DNA into the blood stream. This circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory tests. Measurement of ctDNA has been shown to be useful for following patients with known cancer. It has also been found in the circulation of some patients with early stage cancer. The purpose of this study is to examine blood specimens for the presence of ctDNA in individuals without known cancer who are scheduled to undergo a screening or diagnostic colonoscopy in order to see if the ctDNA test can detect a cancer or precancerous condition at a very early stage before the patient becomes symptomatic. The results of this study should help define the role of ctDNA in the detection of early stage colon cancer and to define how sensitive it is (i.e. how well it picks up cancer when it is present) and how specific it is (i.e. how often is ctDNA found in patients with benign diseases or no abnormalities).

After the participants have undergone the informed consent process, they will have 30 milliliters (approximately two tablespoons) of blood drawn. This will be done prior to their scheduled screening or diagnostic colonoscopy. If the patient has indicated a desire to receive the results of their test, they will receive a written description, as will their primary care physician. The patients will be contacted yearly for up to 5 years by the study staff to learn whether they have been found to have a diagnosis of colon or other cancer.

Blood is drawn and DNA is purified from the plasma. The DNA is analyzed for circulating tumor DNA. The DNA will be stored for up to 10 years.

Plasma ctDNA in Patients Undergoing Diagnostic Colonoscopy

Determination of the Utility of Plasma Circulating Tumor DNA (ctDNA) Measurements for the Detection of Colon Cancer in Patients Undergoing Diagnostic Colonoscopy

Data will be shared with the participants and their primary care physician

Correlation between plasma ctDNA results and any pathology found at time of diagnostic colonoscopy. Determination of true positive, false positive and predictive values for using ctDNA measurements to detect colon cancer and precancerous conditions.

Subjects will be contacted yearly to obtain follow-up information regarding the development of colon or other cancer in order to see if the initial ctDNA measurement detected the cancer before it became clinically apparent.

Pathway Genomics

ALP will receive supervised exercise sessions twice per week for three months and once per week for the following three months. Participants will also take part in biweekly physical activity workshops for the period of the intervention. Each session consists of a warm-up (5-10min), aerobic (20-30min) and resistance exercises (15-20), and cool-down (5-10)stretches lasting in total 60min. The intensity of exercises will be at 65-85% of maximum heart rate as determined by maximal fitness test. Exercise will take place in small groups of two to five people. Behaviour change workshops to aid the uptake and maintenance of physical activity will be delivered every fortnight throughout the whole intervention period totalling 12 workshops. Workshops will also take place in small groups.

The standard care group will not be offered the intervention until the end of the study at 12 months. Participants in this group will be encouraged to continue with their usual lifestyle.

Active Lifestyle Programme

John M Saxton, PhD

The present study will use a randomised controlled trial design to investigate whether moderate to vigorous intensity physical activity (MVPA) will affect the physiological risk markers associated with the development of bowel cancer in individuals previously diagnosed with a bowel polyp. The study will also investigate the effects of the programme on long-term exercise behaviour and changes in psychological variables. A selected sample will also be part of individual interviews at baseline and 12 months to gauge narrative accounts of personal, psychological and sociological beliefs surrounding participation in physical activity. The findings of this study might inform better practices for the prevention of bowel cancer in high risk populations.

After a screening colonoscopy, eligible participants will be randomised to either an active lifestyle programme (ALP) or a standard care group (SC). Participants in ALP will be offered supervised exercise sessions and motivational interviewing for 6 months. Intervention components will cease after 6 months, but participants will be followed-up at 12 months to investigate maintenance to physical activity over the long-term. The SC will not be offered the intervention until the end of the study. Participants in both groups will be invited for assessments at baseline, 3, 6, 9, and 12 months. These include measurements of body composition, cardiopulmonary fitness, physical activity behaviour, and psycho-social variables.

Purpose: A strong body of evidence suggests that lifestyle factors influence cancer risk, and there is now convincing evidence that a physically activity lifestyle is associated with reduced risk of developing colon cancer. However, low self-reported physical activity levels in elderly populations demonstrate the need for physical activity interventions for this patient group that evoke meaningful changes in physical activity behaviour for improvements in CC risk profile to occur.

The purpose of this study is to investigate the effects of a 6 month physical activity intervention on physical activity behaviour and biological markers of CC risk in individuals classified as being at elevated risk of developing the disease following surveillance colonoscopy. The physical activity intervention will be underpinned by Self Determination Theory to create an autonomy-supportive environment, an approach that was recently shown to evoke greater physical activity levels and weight loss than general health education in overweight women. Secondary outcomes will explore the impact of the intervention on aerobic fitness, health-related quality of life and psychological variables (self-efficacy, motivational regulation). In addition, interviews and focus groups will be used to obtain narrative accounts of patient experiences, their perceived health benefits from participating in the intervention and the barriers and facilitators influencing adherence.

Design The proposed study is a randomised controlled trial, with participants stratified for risk status (determined by number and size of polyps identified by colonoscopy). Participants will be randomly allocated to either the physical activity intervention (Active Lifestyle Programme: ALP) or the usual care control group (SC). Outcomes will be assessed at baseline, and after 3, 6, 9 and 12 months. Participants allocated to the ALP group will attend supervised exercise sessions at a facility at the University of East Anglia. These will take place twice per week for 3 months and once per week for an additional 3 months. These will be supplemented by home based exercise to achieve a total of 300 minutes of physical activity each week. Supervised exercise sessions will take place in small groups of maximum 7 participants, and last approximately 60 minutes. The exercise sessions will include a 5-10min warm-up period, followed by 20-30 min aerobic exercise, and 15-20 min resistance exercises. The target intensity of the exercises will be 65-85% of the maximum heart rate as determined by the cardiopulmonary fitness test. Intensity will be monitored with heart rate monitors and the rate of perceived exhaustion (Borg Scale). A short cool-down period will conclude the exercise sessions. In addition, participants will be offered physical activity counselling workshops which will be led in groups, and in a motivational interviewing style. All components of the intervention will be undermined by Self-determination Theory, that is to facilitate feelings of autonomy, competence and relatedness.

To further facilitate behaviour change, participants in the ALP group will be provided with pedometers and an educational workbook, which contains information about the benefits of physical activity in general and in regards to bowel cancer, aids to set personalised goals, and other information relevant to physical activity.

There will also be a purposefully selected sample chosen based on prior consent and demographic variables to take part in face to face interviews at 1 and 12 months. Furthermore 3 focus groups containing, participants from the EX and UC group will take place alongside a focus group with Health professionals after the intervention has taken place.

Recruitment and Consenting Potential participants will either hear about the study via posters and flyers at the Big C Cancer Charity at NNUH or they will be approached by a specialist nurse during a consultation appointment before their colonoscopy. However, the recruitment procedure will be the same for each path from the point of their pre-colonoscopy consultation appointment.On the day of the consultation, a nurse will inform the potential participants about the study and give them an invitation letter, and a participant information sheet. At this meeting, the nurse will also provide the patient with a consent form, asking for their agreement to be contacted by a researcher. If the patient gives consent to be contacted, a researcher will call the patient prior to their screening colonoscopy to provide further information about the study, and arrange an appointment to obtain consent for biopsies to be taken during their colonoscopy. If the patient is diagnosed with polyps during the screening colonoscopy, the researcher will arrange another appointment post-colonoscopy to carry out baseline assessments and obtain full study consent.

Baseline assessments will include a maximal fitness test, assessment of current physical activity using accelerometers and self-report, questionnaires assessing quality of life and psycho-social variables, and body composition.

After the completion of all baseline assessments, participants will be randomised to one of the two study arms. This will be carried out by a person not directly involved in the research. The person undertaking the maximal fitness test will be blinded to group allocation throughout the whole duration of the study. The person carrying out the intervention will not be blinded to group allocation.

Physical Activity Intervention With People at Increased Risk of Developing Colon Cancer

A Randomised Controlled Trial Investigating the Effect of a 12 Month Active Lifestyle Programme on Physiological Risk Markers and Physical Activity Behaviour in Those Diagnosed With Intermediate or High Risk for Colon Cancer

Physical activity diary used to assess compliance

Body weight and body height will be used to calculate BMI

Assessed with a maximal cardiopulmonary exercise test on a bicycle ergometer

Assessed with Barriers to Exercise questionnaire

Waist and hip circumference will be used to calculate the waist-to-hip ratio

University of East Anglia

Standard colonoscopy - no distal colonoscope attachment will be used in this arm

The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure

The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure

Olympus transparent cap

Medivators Endocuff

Control

The goal of this study is to compare two FDA approved distal colonoscope attachment devices, in order to identify which device can increase adenoma detection rate the most without increasing procedure time or risk.

Although mortality from colon cancer is decreasing, it remains the second leading cause of cancer related death in the United States. There are multiple factors contributing to this decrease, such as increased awareness, improving screening techniques, etc.

Of the available modalities approved for colon cancer screening in the United States, colonoscopy is considered the gold standard. Colonoscopy has the advantage of being both diagnostic and therapeutic, allowing the removal of pre-cancerous polyps, before the polyps can transform into cancer. Colonic polyps can occur at any location from the rectum to the cecum. Colonoscopy has been shown to be more effective in decreasing incidence of cancer in the left colon but remains limited in the detection of right sided polyps /lesions 2. This difference based on location is thought to be due to several reasons. Typically the right side of the colon is less clean than the left side during colonoscopy, thereby impairing visualization of polyps. This problem has been overcome by incorporating a "split bowel preparation", which has not become standard of care. However, the problem of not being able to visualize polyps behind folds seen in the colon persists despite improvements in the quality of cleansing of the colon. Various endoscopic technologies have been introduced with the goal of assisting with the manipulation of such colonic folds, and thereby reducing chances of missing polyps behind fold. Two such colonoscope assisted devices including the distal transparent cap and the Endocuff endoscopic overtube.

The Endocuff overtube is a small device with flexible arms arranged in 2 rows. Each row has 8 short, soft arms projecting away from the device. These arms are used to peel back the colonic folds without causing physical damage to enable visualization behind colonic folds. The use of Endocuff overtube has shown promising results in terms of cecal intubation rate and time as well as adenoma detection rates 3.

The transparent cap attachment is a clear plastic device that fits at the end of the colonoscope and extends a short distance past the tip of the colonoscope. It aids in the manipulation of folds and in maintaining a suitable distance from the mucosa, with the goal of improving visualization. Although some studies comparing cap fitted colonoscopy to standard (non- attachment) colonoscopies have shown improved adenoma detection 4, others have shown no significant benefit 5.

Although, these devices have been compared with conventional colonoscopies (i.e without any distal attachment), to the investigator's knowledge, there are currently no studies that have compared these two distal colonoscope attachment devices head-to-head, and none has specifically evaluated effects on detection of right sided adenomas. Also, here at UCDavis, these devices are being used specifically in diagnostic colonoscopies for removal of large polyps and the choice of which specific device is used depends on level of comfort of the advanced endoscopist. The endoscopists participating in the investigators' study do not currently use these devices as part of their routine colonoscopies, thus it is important to provide head to head comparison of these devices to help guide management practice.

Therefore, the investigators' goal is to compare the Endocuff overtube assisted, transparent cap fitted, and non-cap fitted (standard) colonoscopy in patients presenting to UC Davis Medical Center for screening colonoscopies.

In addition, 2 of the 3 investigators will employ the water exchange method during for all arms of the trial, while the other investigator will employ the conventional air method of colonoscopy.

Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments

The investigators will compare adenoma detection rate at completion of study across the 3 arms

The investigators will compare proximal adenoma detection rate at completion of study across the 3 arms

The investigators will compare cecal intubation rate at completion of study across the 3 arms

The investigators will compare colonoscopy withdrawal time rate at completion of study across the 3 arms

University of California, Davis

Standard colonoscopy - no distal colonoscope attachment will be used in this arm

Control: No distal colonoscope attachments

The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure

Olympus transparent cap: distal colonoscope attachment

Olympus Transparent Cap

The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure

Medivators Endocuff: distal colonoscope attachment

No distal colonoscope attachment will be used in this arm

Control: No distal colonoscope attachments

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PeerScope B System™ Clinical Protocol	NCT01483040	Colon Cancer Colon Diseases Colon Polyps Colon Adenomas	colonoscopy sys...	18 Years - 70 Years	PeerMedical Ltd.
APACC Study:Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence	NCT00224679	Colon Adenomas	Aspirin	18 Years - 75 Years	Assistance Publique - Hôpitaux de Paris
Plasma ctDNA in Patients Undergoing Diagnostic Colonoscopy	NCT02665299	Colon Cancer Colon Adenomas Colon Polyps		18 Years -	Pathway Genomics
PeerScope B System™ Clinical Protocol	NCT01483040	Colon Cancer Colon Diseases Colon Polyps Colon Adenomas	colonoscopy sys...	18 Years - 70 Years	PeerMedical Ltd.
Physical Activity Intervention With People at Increased Risk of Developing Colon Cancer	NCT02724306	Colon Polyps Colon Adenomas	Active Lifestyl...	60 Years -	University of East Anglia
Physical Activity Intervention With People at Increased Risk of Developing Colon Cancer	NCT02724306	Colon Polyps Colon Adenomas	Active Lifestyl...	60 Years -	University of East Anglia
Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments	NCT02665741	Colon Cancer Sc... Colon Polyps Colon Adenomas Water Exchange ...	Olympus transpa... Medivators Endo... Control	50 Years -	University of California, Davis

Spots Global Cancer Trial Database for colon adenomas