Symptoms and General Pathology

All Conditions

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasms

Digestive System Diseases

Colonic Polyps

Respiratory Tract Infections

Polyps

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

The removal of small colorectal polyps up to 8 mm is performed using cold snare polypectomy.

cold polypectomy

The removal of small colorectal polyps up to 8 mm is performed using conventional polypectomy.

conventional polypectomy

The aim of this study is to compare cold snare polypectomy and conventional polypectomy for the removal and retrieval of small colorectal polyps.

Cold snare polypectomy for colorectal polyps up to 8 mm is expected to be more effective than conventional polypectomy.

Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy

Showa Inan General Hospital

Digestive Disease Center

The cultivation of "Yellowstone" carrots will be conducted by DanRoots A/S.DanRoots, Organic Vegetables, Bjerringbro, Denmark.Juice is produced and taste corrected by Orskov Food, Denmark in collaboration with Naturfrisk, Ørbæk.

Analysis of carrot juice for falcarinol and falcarindiol content will be done at random from 10 samples leaving the factory and 10 samples collected after 30 days storage at participant's homes for each batch.

Placebo juice is produced from natural flavours and taste corrected by Orskov Food, Denmark in collaboration with Naturfrisk, Ørbæk. The taste is corrected to prevent enabling differentiation between carrot juice and placebo.

Consumption of 100 ml of carrot juice daily for 1 year

Carrot juice from Yellowstone carrots cultivars

Consumption of 100 ml of placebo juice daily for 1 year

Placebo juice

Gunnar Baatrup, Professor

Alexandra D Agache, Postdoc

The goal of this prospective randomized double-blinded bi-national study is to test the prophylactic effect of polyacetylenes from carrots on the population of patients who had a resection of high-risk adenomas of the large bowel.

The main question it aims to answer is: Will carrot juice rich in polyacetylenes inhibit neoplastic transformation and growth in high-risk humans?

Participants will have to drink 100 ml of juice daily after the adenoma resection for 1 year and keep a simple diary/calendar.

Researchers will compare the group with ingestion of FaOH/FaDOH rich carrot juice versus the group consuming placebo juice, to see if the polyacetylenes significantly reduces neoplastic transformation and growth in high-risk patients.

The study is a prospective double-blinded randomized controlled trial carried out in four centers: one Danish (Department of Surgery, Odense University Hospital - OUH) and three Swedish (Södersykehuset, Stockholm - KUH; University Hospital, Uppsala - UUH; Sahlgrenska Goteborg - SUH).

The investigators will organize two parallel arms of 400 patients: an intervention arm (consumption of 100 ml active carrot juice daily) and a control arm (consumption of 100 ml placebo juice daily) in a 1:1 randomized allocation ratio for 1 year. The project is structured in 2 working packages (WP):

1. The clinical trial (including cultivation and quality control of carrots and juice production; quantification of FaOH and FaDOH in the carrot and the placebo juice and the randomized trial)
2. The assessment of patient compliance and ways to improve it (Umeå Institute of Design, Umeå University - UMU).

The investigators hypothesize that the difference between the active arm (carrot juice) and the control arm (placebo juice) measured by a combined endpoint of total number of recurrent adenomas multiplied with mean size of recurrent adenomas will mediate a 20% reduction or larger in both size and number.

Outcomes will be investigated through standard colonoscopy report, questionnaires, calendars and diares.

The randomization is stratified by inclusion center, each having its own block of 50/50 distribution between active and placebo arm.

The patients will collect 8 L of juice, the diary, calendar and a questionnaire every 2 months. At this meeting the patients will also have a follow-up discussion with the project nurse.

All patients will undergo colonoscopy after one year from the resection and in addition, for the piecemeal resections there will also be a local follow up colonoscopy after 3 months. Information about recurrence, the number of polyps, polyp size and characterization will be registered in the database. Full compliance is defined as consumption of \> 75% of the juice delivered. Consumption data for all patients will be kept for compliance analysis.

Data will be analyzed using exact methods for binomial data. The combined endpoint will be the total number of recurrent adenomas multiplied with mean size of recurrent adenomas in the relevant treatment group.

Participation is voluntary with no economic compensation, and the patients are informed orally and in writing according to the information accepted by the ethics committee.

Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps

Polyp Prophylactic Properties of Polyacetylenes in Patients With Previous Polypectomy

The combined endpoint (number x size of polyps) after 1 year of treatment.

A covariate analysis of carrot consumption (concentration of polyacetylenes expoure)measured through diaries, calendar and questionnaires and the findings at the 1 year colonoscopy

Assesment of compliance rate through diary, calendar marks and questionnaire

Assesment of side effects through questionnaire

Assesment of acceptance and ways to improve carrot products through diary and questionnaire

Karolinska Institutet

Umeå University

Uppsala University Hospital

Sahlgrenska University Hospital, Sweden

Svendborg Hospital

Odense University Hospital

Syndrome

Colonic Neoplasms

There is no intervention with this arm. Completion of the website is part of enrollment.

The intervention consists of participants receiving the services of a patient navigator to address individual barriers to adhering to the "personal prescription" for colon and rectal cancer screening.

There is no intervention in this arm. Patients diagnosed as positive for Lynch Syndrome use genetic counseling to discuss medical and family history and genetic risk of CRC, including genetic factors such as DNA mismatch repair genes, autosomal dominant inheritance, cancer risks associated with LS, screening recommendations, and genetic testing. There is no intervention. This is standard care.

Participants diagnosed positive for Lynch syndrome use genetic counseling as in Arm 3 and in addition receive the services of a patient navigator to address individual barriers to adhering to the CRC screening recommendations.

Patients are randomized to receive the assistance of a patient navigator to understand, obtain assistance with following the screening recommendations of the personal prescription given to them by the website survey.

Patient Navigator

Electra Paskett

This randomized clinical trial studies website access or genetic counseling with or without patient navigators on adherence to colorectal cancer screening recommendations in patients with newly diagnosed colorectal cancer and their first degree relatives. Websites for colorectal cancer prevention and genetic counseling may be effective methods to help people learn about cancer screening. Patient navigators may improve adherence to colorectal cancer screening recommendations. It is not yet known whether website access or genetic counseling is more effective with or without patient navigators.

PRIMARY OBJECTIVES:

I. Test the comparative-effectiveness of the interventions (i.e., website +/- navigator or genetic counseling +/- navigator) in a randomized controlled trial, using colorectal cancer (CRC) cases as the unit of randomization/analysis on adherence to individualized CRC screening recommendations.

SECONDARY OBJECTIVES:

I. Examine the cost effectiveness of the interventions, assessing the effect of the interventions on subgroups (i.e., Lynch syndrome positive vs. Lynch syndrome negative; probands vs. relatives; older vs. younger patients, etc), and barriers to adherence, as well as how the navigators resolve barriers.

II. Overscreening will be explored.

OUTLINE: Participants are assigned to 1 of 2 study components based on LS status. Within each component, participants are randomized to 1 of 2 arms.

COMPONENT #1 (Lynch Negative Proband and their first degree relatives (FDRs):

ARM I: Participants access a website to deliver a "personalized prescription for CRC prevention" based on age, Lynch Syndrome status, cancer history, age of 1st degree relative with CRC, and personal CRC screening history.

ARM II: Participants access a website as in Arm I and receive the services of a patient navigator to address individual barriers to adhering to the "personal prescription" within 1 month.

COMPONENT #2 (Lynch Positive Proband and their FDRs):

ARM III (Lynch positive proband): Participants use genetic counseling to discuss medical and family history and genetic risk of CRC, including genetic factors such as deoxyribonucleic acid (DNA) mismatch repair genes, autosomal dominant inheritance, cancer risks associated with LS, screening recommendations, and genetic testing.

ARM IV (Lynch positive proband): Participants use genetic counseling as in Arm III and receive the services of a patient navigator to address individual barriers to adhering to the CRC screening recommendations within 1 month.

After completion of study treatment, patients are followed up at 12-14 months.

Adherence to Colon Cancer Screening (ACCS)

Ohio Colorectal Cancer Prevention Initiative: Adherence to Colon Cancer Screening (ACCS) Project:Your Personal Prescription For Colorectal Cancer Screening.

For participants who are within the recommended guidelines, success would be defined as receiving no further screening. For those outside of the recommended guidelines, success would entail receiving a screening test. The outcome will combine medical record review and self-report by using medical record review when available and self-report otherwise. Evaluations will use a generalized estimating equations (GEE) approach with empirical sandwich variance estimators.

Analysis will consist of a cost analysis of the intervention incorporating project expenditures and both financial and non-financial costs incurred by the project participants. Financial benefits from the project will be incorporated into the cost analysis to produce a net cost of the interventions. These financial benefits will include expenditures for unnecessary or "overscreening" prevented by the interventions. The results of the net cost analysis will be combined with the outcome measures for screening interventions to establish the cost per guideline concordant screening.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Nutritional and Metabolic Diseases

Obesity

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Participants follow their normal diet (not including beans for 8 weeks)

Regular Diet

Participants add 1/2 cup of canned beans per day to their diets for the first 2 weeks. This is increased to 1 cup per day for the following 6 weeks of the study.

Navy Beans (Canned)

Carrie Daniel-MacDougall, PHD

You are being asked to take part in this study because either you are a survivor who has a previous history of colorectal cancer or an MD Anderson patient who had a precancerous colorectal polyp or you have a previous history of colorectal cancer, and you have a current adult body mass index (BMI) score of 25 or higher.

The BMI score is used as an indicator of the level of body fat, based on height and weight.

The goal of this clinical research study is to learn if eating canned, pre-cooked beans can help improve the levels of healthy bacteria in the digestive system and reduce the effects of obesity on cancer risk.

This is an investigational study.

Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.

Study Groups:

If you are found to be eligible, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups (intervention or control). This is done because no one knows if one study group is better, the same, or worse than the other group. Both groups will be given a diet to follow for 8 weeks.

Intervention group participants will add canned beans into their diets beginning at ½ cup per day. This will be increased to 1 cup per day during the first 2 weeks, and then will continue at 1 cup per day for the following 6 weeks of the study. You will be asked to keep a log of your bean consumption during this time.

Control group participants will be instructed to follow their normal diet (not including beans) for 8 weeks.

Length of Study:

Your active participation on the study will last a total of 20 weeks. Your participation on the study will be over after the follow-up period.

Long-Term Follow-Up:

Up to 2 times each year for up to 5 years, a member of the study staff will contact you and ask about how you are doing. You will be contacted by phone, email, or standard mail. These calls will last 15-20 minutes each.

At 6 months and 1 year after your last visit, you will complete the same questionnaires you completed at screening.

Study Visits:

At each visit, your waist measurements and weight will be collected.

Every 4 weeks (Visits 2, 3, 4, 5, and 6), blood (about 3 tablespoons) will be drawn for routine tests. You will be asked to bring a stool sample to each visit and mail a stool sample at the end of week 1 during the intervention. You will be provided with a container and instructions to collect each stool sample. You may send your stool sample back to the study staff by mail. If you choose to send it by mail, you will be given a pre-paid envelope for this.

At Visit 4, your study group assignment will be switched, and you will be assigned to the opposite group and diet from your first assignment (meaning intervention group members will be switched to the control group as well as the other way around). You will follow this new diet for the remaining 8 weeks.

The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial

The primary outcome measures will be intra- and inter-individual changes in stool 16S rRNA gene profiles at baseline, week 4 and week 8 for each cross-over period.

The primary outcome measures will be intra- and inter-individual changes in blood makers and metabolites at baseline, week 8 for each cross-over period.

M.D. Anderson Cancer Center

1. st sub-grouup : Low risk to develop a CRC
2. nd sub-group : Moderate risk to develop a CRC
3. rd sub-group : High risk to develop a CRC

* remote support in physical activity and nutrition via digital media
* monthly collective physical activity sessions
* logbook

Low risk

* remote support in physical activity and nutrition via digital media
* monthly collective physical activity sessions
* one collective health education session
* logbook

Moderate risk

* remote support in physical activity and nutrition via digital media
* monthly collective physical activity sessions
* one collective health education session
* 3 individual sessions of motivational coaching
* connected watch
* logbook

High risk

Anne CATTEY-JAVOUHEY, MD, PhD

It has been estimated that 19,000 Colorectal Cancers (CRC) could be prevented each year in France by changing individual risk behaviours (sedentary lifestyle, overweight, diet, alcohol). The cancer screening appears to be an opportune moment for health promotion and to inform about CRC risk factors.

The PRECÔTION study proposes an innovative scheme based on informative, motivational and community-based approaches. The objectives are to take advantage of patients' visits for colonoscopy to raise awareness and initiate individual prevention actions according to their own risk in order to modify individual risk behaviour.

Patients who come for a colonoscopy at the Centre Léon Bérard and who are negative (80% of cases) will benefit from an evaluation to identify their individual risk factors, determine their level of risk level for CRC and their motivation to change their behaviour.

Participants with a low level of risk will receive remote support in physical activity and nutrition via digital media based on a motivational approach. Participants will be proposed a monthly collective physical activity session, which will allow them to interact with each other and develop a community approach. Participants with an intermediate level of risk will be offered a collective health education session, in addition to the the support offered to participants with a low level of risk. Participants with a high level of risk will receive, in addition to the the support offered to participants with an intermediate level of risk, an individual motivational coaching and a connected watch. A logbook will also be given to all participants to accompany them on the different tools, especially for monitoring their goals.

The PRECÔTION study aims to evaluate these tools as innovative means of prevention before evaluate their effectiveness on a larger scale.

Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches

Pilot Study to Improve Primary Prevention of Colorectal Cancer by Motivational and Community-based Approaches, According to Individual Risk Level, in People Undergoing Colonoscopy

Participation rate at each modality of the programme

Participation rate to the study (number of participants/number of eligible persons)

Satisfaction, assessed by a Likert scale on a self-administered questionnaire

Evaluate the observance to the whole programme, for each subgroup

World Cancer Research Fund international questionnaire Score : from 0 (worse score) to 7 (better score)

Evaluate the effects on physical activity level using the IPAQ

Self-administered questionnaire (questionnaire specially designed for the study, no titlle) Score : from 0 (worse score) to 9 (better score)

Centre Leon Berard

Adenocarcinoma

Rectal Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Dean E Brenner, M.D.

The investigators are undertaking a multi-center, 13000 subject validation study of several biomarkers for early detection of colon cancer. There are stool based biomarkers and blood based biomarkers being validated in this study. The biomarkers will be compared with colonoscopy and with FIT (fecal immunohistochemistry) tests which are the current standards for colon cancer screening. This is an NCI-early Detection Research Network funded project. The population targeted for this study are those persons undergoing colonoscopy for screening. Prior to colonoscopy or even prepping for colonoscopy, subjects will provide blood and stool samples as well as specific data regarding their GI and general medical history and concomitant medications. If subjects are interested in participating, arrangements will be made to see them. The informed consent process will take place, blood will be obtained, data will be obtained, and the stool kit described and given to the subject to take home. Stool samples will be sent back to the University of Michigan using prepaid mailing labels.

The goal of this trial is to estimate the sensitivity and specificity of stool vimentin methylation, serum galectin-3 ligand, and fecal immunochemical testing for colorectal adenocarcinoma, or 2) screen relevant neoplasms (high-grade dysplasia or adenoma with ≥25% villous histologic features or adenoma measuring ≥1 cm in the greatest dimension or sessile serrated polyps measuring 1 cm or more in diameter) as single markers and in combination. Asymptomatic subjects undergoing a colonoscopic procedure for screening for colorectal cancer are eligible. Patients who have a first or second positive fecal immunochemical test, a positive stool guaiac test or a positive Cologuard test are eligible. Up to 2,500 stool blood or Cologuard positive subjects will be recruited on this protocol. Up to an additional 1,000 subjects who have not had previous FIT tests will be recruited. Subjects with a negative stool blood or Cologuard test are not eligible for enrollment. Subjects will meet with research staff prior to initiation of any colonoscopic preparative procedure. After completing informed consent, they will complete Early Detection Research Network (EDRN) data element forms. Blood and urine will be obtained following EDRN standard operating procedures (SOPs). Subjects will be provided with kits to collect stool samples for fecal immunochemical test (FIT) and processing for stool based biomarkers. The collected samples will be shipped to the Central Laboratory at the University of Michigan or German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ), Heidelberg, Germany where the stool will be homogenized, aliquoted, and stored at the Umiversity of Michigan CLASS laboratories . The FIT tests will be sent to the Central Laboratory at the University of Michigan or to DKFZ for quantitative analysis following standard operating procedures provided by Eiken Chemical Company. Data from the screening colonoscopy will be obtained. One year after colonoscopy, subjects will be contacted to determine if they have had a neoplastic colorectal diagnosis or other neoplastic events. Data management and protocol coordination will be performed by the Data Management and Coordinating Center (DMCC) of the EDRN along with the GLNE Prevention Research Base at the University of Michigan and will include a Web-based front end and relational database backend, with biosample tracking (VSIMS). Biosamples will be managed in a high quality repository facility at the University of Michigan.

We will estimate sensitivities and specificities and the corresponding confidence intervals of the stool DNA tests and serum/plasma tests for detection of invasive colorectal neoplasms and for screen relevant neoplasias (Aim 1). We will then test the primary hypothesis to confirm the clinical accuracy of a particular biomarker test or panel (Aim 2). The specific primary hypothesis will be defined prior to data analysis based on state of the art information available at that time about candidate biomarkers and tests. Several specific examples of potential primary hypotheses are given to justify study sample size. Finally, several alternative tests and multi-marker panels will be evaluated. (Aim 3). In secondary analysis, we will (a) provide measures of diagnostic accuracy standardized to the age and gender distribution of US population and (b) assess the effect of subject heterogeneity on the marker performance. A primary objective is to establish an archive of appropriately preserved stool, serum, plasma and DNA human biospecimens to be used by EDRN-approved investigators for future validation and biomarker discovery research (Aim 4).

Two 10 ml red top (serum) tubes Three 10 ml purple top (EDTA)tubes 25 ml of urine 2 Fecal Immunohistochemical Tests (FIT) Stool

Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma

Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma

Test the hypothesis that sensitivity of stool vimentin methylation and/ the blood based panel (serum galectin-3 ligand, CEA, methylated genes BCAT1/IKZF1, Hypomethylated LINE1 from circulating cell free DNA) when combined with fecal immunochemical testing (FIT) will significantly improve the sensitivity of FIT for the detection of colorectal adenocarcinoma, and maintain specificity greater than 0.80.

To test the hypothesis that blood based panel (for example, serum galectin-3 ligand, CEA, methylated genes BCAT1/IKZF1, Hypomethylated LINE1 from circulating cell free DNA), at the same sensitivity of that for fecal immunochemical testing (FIT) for the detection of colorectal adenocarcinoma, has a specificity greater than 0.55 with an anticipated specificity ≥ 0.70.

To test the hypothesis that stool vimentin methylation, the blood based panel (serum galectin-3 ligand, CEA, methylated genes BCAT1/IKZF1, Hypomethylated LINE1 from circulating cell free DNA), when combined will improve the detection of colorectal adenocarcinoma: at sensitivity ≥0.98 it will have a specificity significantly greater than 0.55.

Early Detection Research Network

University of Michigan

Professor Internal Medicine

Adenoma

Observational study on consecutive persons over the age of 55 years presenting for screening colonoscopy

Thomas Rösch, MD

Screening colonoscopy has been established as the most effective means of colorectal cancer prevention. This is based on the fact that colonoscopy detects and removes colonic polyps (adenomas) which are known to progress to cancer if left untreated. The present study examines the question whether case volume (i.e., the number of colonoscopies performed per year) correlates with colonoscopy quality, i.e., adenoma detection rate.

21 private practice gastroenterologist endoscopists from Berlin performed a prospective quality assessment study including at least 10.000 screening colonoscopies. After informed consent, patients data are included (age, sex, family history, colonoscopy performance parameters and findings, therapy performed, histology of biopsies and/or polypectomies, complications (immediate and late) and patient acceptance. The latter was retrieved by patient questionnaires returned after a minimum of 2 weeks. Data were centrally collected in an anonymized way

Primary outcome parameter:

* Correlation of adenoma detection rate with case volume and other confounding factors (e.g., withdrawal time)

Secondary outcome parameters:

* Complications and method of assessment (immediate recording versus later questionnaire enquiry)
* Quality of bowel preparation in relation to outcome Patient acceptance in relation to procedural factors (e.g., sedation)
* Quality of pathology reports and histologic outcome of polypectomy

Later follow-up (after 5-10 years) of the preventive effect of colonoscopy is planned and has been part of the protocol and patient consent form.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy	NCT00763425	Colorectal Canc...	cold polypectom... conventional po...	20 Years -	Showa Inan General Hospital
Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps	NCT06335420	Colorectal Canc...	Carrot juice fr... Placebo juice	18 Years -	Odense University Hospital
Adherence to Colon Cancer Screening (ACCS)	NCT02112747	Colon Cancer Rectal Cancer	Patient Navigat...	25 Years - 75 Years	Ohio State University Comprehensive Cancer Center
The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial	NCT02843425	Colorectal Canc...	Regular Diet Navy Beans (Can...	30 Years -	M.D. Anderson Cancer Center
Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches	NCT05568667	Colorectal Canc...	Low risk Moderate risk High risk	18 Years - 80 Years	Centre Leon Berard
Adherence to Colon Cancer Screening (ACCS)	NCT02112747	Colon Cancer Rectal Cancer	Patient Navigat...	25 Years - 75 Years	Ohio State University Comprehensive Cancer Center
Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma	NCT01511653	Colon Cancer Rectal Cancer		40 Years -	University of Michigan
Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy	NCT00763425	Colorectal Canc...	cold polypectom... conventional po...	20 Years -	Showa Inan General Hospital
The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial	NCT02843425	Colorectal Canc...	Regular Diet Navy Beans (Can...	30 Years -	M.D. Anderson Cancer Center
Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches	NCT05568667	Colorectal Canc...	Low risk Moderate risk High risk	18 Years - 80 Years	Centre Leon Berard
Case Volume and Adenoma Rate During Screening Colonoscopy	NCT00860665	Colorectal Canc...		55 Years - 85 Years	Charite University, Berlin, Germany

Spots Global Cancer Trial Database for colorectal cancer prevention