Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Antibodies

Immunomodulating Agents

Nivolumab

Atezolizumab

Ipilimumab

Immunoglobulins

Nitrofurazone

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

This cohort will consist of 1000 healthy volunteers from Poland.

This cohort will consist of 160 patients with melanoma.

Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).

Collection of stool samples

Anna Philips, PhD

Emilia Strycharz-Angrecka

Jan Majta

Knowledge about the correlations between the composition of the gut microbiome and a wide range of diseases has substantially increased in recent years. Nonetheless, there is no reference set of information about the microbiome in Poland. The development of such a reference will allow polish scientists conducting research in the field of interaction between gut flora components and such characteristics as lifestyle, certain diseases or patient's responses for treatment. Following the example of such countries as the United States, investigators propose to build a unique set of scientific processed information describing the variability of the polish population microbiome (Polish Microbiome Map). The investigators will provide a reliable dataset that will characterize the gut microbiomes and their diversity in the polish population. Additionally, thanks to the creation of the standard protocol for microbiome data collection the research conducted by the MMP users will be comparable with the information deposited in MMP.

Polish Microbiome Map

Microbial DNA - stool samples sequenced by next-generation sequencing platform.

It includes questions about healthy volunteers' and patients' eating habits that may relate to their health.

The Institute of Bioorganic Chemistry, Polish Academy of Sciences

National Center for Research and Development, Poland

Ardigen

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Digestive System Diseases

Obesity

Polyps

Colorectal Neoplasms

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Polish Microbiome Map	NCT04169867	Melanoma Healthy Volunte... Microbiome Metagenome Immunotherapy	Collection of s...	18 Years -	Ardigen
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
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

Spots Global Cancer Trial Database for stool samples