Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

The patients to be included in this group will be those with Stage I (initial tumor stage). The tumors classified in stage I will be tumors in which the invasion of the submucosa and / or the invasion of the muscularis propria occur. This group will include patients diagnosed preoperatively with tumor stage T1-T2 N0.

The patients to be included in this group will be those with Stages II and III, that is, advanced tumors at the time of preoperative diagnosis. Tumors included in this group invade the perirectal fat and / or the surface of the visceral peritoneum and / or invade or adhere to adjacent organs or structures. In addition, any tumor stage with lymph nodes without distant metastases will be included in this group.

The patients to be included in this group will be those with Stage IV (disseminated tumor stage) in the initial study of the disease. Patients with distant metastases in one organ or more than one organ will be included.

One stool sample will be taken at baseline for microbiota characterization

Stool sample

Characterization of tissue microbiota before and after surgery.

Rectal mucosa sample

Characterization of tissue microbiota and dysfunction

Mesorectal adipose tissue sample

Subcutaneous adipose tissue sample

Visceral adipose tissue sample

Dietary assessment will be taken at baseline

Dietary assessment

Antoni Codina Cazador, MD, PhD

Antoni Codina, MD, PhD

The equilibrium of intestinal microorganisms is essential for health an imbalance has been associated with an increased risk in the development of different pathologies; including colorectal cancer.

Rectal cancer is the third most common neoplasm worldwide and the complete excision of the mesorectum is a major prognostic factor.

The identification of microorganisms in the adipose tissue that surrounds the small intestine in inflammatory diseases, together with bacterial alterations found in colonic mucosa and feces in patients with rectal cancer in comparison with healthy individuals indicates that microbiome alteration plays an essential role in pathogenesis.

The mesorectal microbiome in rectal cancer patients stills unknown and given its importance in the prognostic of the disease the goal of this study is to identify microbial profiles that allow predicting rectal cancer patients with a poor prognosis.

The 5-year survival rate for patients with rectal cancer is 64%. Despite the development of personalized cancer treatments, the implantation of surgical approaches with more precise fields of vision and the current prognostic factors based on the quality of resection of the surgical specimen (intact margins and complete resection of the mesorectum), the long-term results for patients with rectal cancer remain grim.

Recently, it has been shown that dysfunctional fat tissue is characterized by tissue remodeling, grater lipids deposits and high adipokines secretion generates a pro inflammatory state, hypoxia and angiogenesis. These products generated by dysfunctional peritumoral adipose tissue create an ideal microenvironment for initiation and tumor progression.

The presence of microbiome in the mesentery of patients with colitis has confirmed the translocation of microorganisms from the intestine to adjacent tissues, together with the differences found in the bacterial composition in colonic mucosa and fecal samples between patients with rectal cancer and healthy individuals, and the prognosis value of the quality of mesorectum resection suggests that the microbiome present in lymph-fatty tissue in patients with rectal cancer may be a key element in mesorectum dysfunction, progression and dissemination of oncological disease.

Whole blood, faeces, rectal mucosa, mesorectal, subcutaneous and visceral adipose tissue

Mesorectal Microbiome as a Prognostic Factor in Patients With Rectal Cancer

Mesorectal Microbiome as a Prognostic Factor in Patients With Rectal Cancer and Analysis of it's Applicability in Neoadjuvant Treatment

Correlation between mesorectal microbial signatures and survival

Qualitative and quantitative analysis of the mesorectal microbiome in patients with rectal cancer

Analysis of mesorectal tissue inflammation, angiogenesis and hypoxia and its correlation with microbial dysbiosis

Correlation between mesorectal dysfunction and response to neoadjuvant treatment

Girona Biomedical Research Institute

University Hospital of Girona Dr.Josep Trueta

Principal Investigator

Nervous System Diseases

Symptoms and General Pathology

Syncope

residents of the state of New Mexico (NM) potentially exposed to radioactive fallout fromthe Trinity nuclear test conducted in 1945

Steven L Simon, Ph.D.

Background:

The first nuclear bomb test took place in New Mexico in July 1945. This was called the Trinity test. Researchers want to learn how it affected the health of people who lived in New Mexico at the time of the test. To do this, they want to learn about the diet and daily life of those people at that time. They want to study Native Americans, Hispanic/Latinos, and non-Hispanic/Latino whites.

Objective:

To learn about the health risks for people who may have been exposed to radiation from the Trinity nuclear test.

Eligibility:

People who:

* Are Native American, Hispanic/Latino, or non-Hispanic white
* Are age 70 and older
* Lived near the fallout region of the Trinity test and know about lifestyle and dietary patterns in New Mexico in the 1940s and 1950s

Design:

Participants will be screened with a questionnaire.

Participants will answer questions in an interview or a focus group. This will be at a place like an office, tribal or community center, or library. It will take up to 2 hours. The interview or group session will include:

* Questions about their and their family members activities and eating habits in the 1940s and 1950s
* A card-sorting exercise: There will be cards with pictures and names of certain foods. They will sort the cards into 2 piles: those that were consumed and those that were not.
* Filling out a chart of their family members and the foods they ate

If participants give permission, their interview or group session will be recorded.

...

Over the last four decades, assessments of health risks based on estimated radiation doses received by the public have been completed for all major U.S. nuclear testing sites and nuclear fuel cycle facilities in the U.S. except for the Trinity test. This research plan is for a radiationrelated cancer risk projection study for the residents of the state of New Mexico (NM) potentially exposed to radioactive fallout from the Trinity nuclear test conducted in 1945. Data to be collected on diet and lifestyle from the three main ethnic groups in NM (white, Hispanic, and Native American) via focus groups and key informant interviews will be used to derive means and ranges of exposure-related parameters for a dose assessment and risk projection. As preliminary work to this proposal, in 2014 we conducted a pilot study to obtain information from 9 key informants (maximum number allowed under OMB regulations prior to clearance) determined that the elders could recall the relevant time period and relevant lifestyle practices. This work established that it is possible to: 1) locate elderly representative of the ethnic groups, 2) assemble groups of members of tribal, a n d Hispanic/Latino communities in New Mexico who were alive in 1945 at the time of the test to participate in focus groups, and 3) obtain lifestyle and diet information to be used for refining focus group interviewing tools. Due to the successful completion of the pilot phase, here we are proposing a second phase to collect data, on a larger scale, via focus group and individual interviews, on lifestyle and diet from up to 150 Native American, Hispanic/Latino, and non-Hispanic white participants living in New Mexico who were alive at the time of the Trinity detonation (currently greater than or equal to 70 years old). The data collected in the proposed study will allows us to estimate exposure-related parameter values that can be used in fallout dose assessment models to estimate external and internal radiation doses to representative persons in all counties in New Mexico by ethnicity, gender, and age. Those doses will be used with published risk models and coupled with literature-derived parameters on risk/unit dose to project the excess cancers (per 1,000 persons within each strata) expected. Endpoints are leukemia, thyroid cancer, stomach cancer, and colon cancer.

Study to Estimate Radiation Doses and Cancer Risks From Radioactive Fallout From the Trinity Nuclear Test

prediction of number of excess cancers of: colon, lung, active bone marrow, stomach, and thyroid

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Mesorectal Microbiome as a Prognostic Factor in Patients With Rectal Cancer	NCT04804956	Rectal Cancer	Stool sample Rectal mucosa s... Mesorectal adip... Subcutaneous ad... Visceral adipos... Dietary assessm...	18 Years - 18 Years	University Hospital of Girona Dr.Josep Trueta
Study to Estimate Radiation Doses and Cancer Risks From Radioactive Fallout From the Trinity Nuclear Test	NCT02734303	Cancers		70 Years - 100 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for dietary assessment