Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Inflammation

Breast Neoplasms

Breast Diseases

Skin Diseases

Menopause

All Drugs and Chemicals

Hormones

Jenny Chang-Claude, Prof. Dr.

The MARIEplus study is a prospective cohort of breast cancer patients recruited into the MARIE (Mamma Carcinoma Risk factor InvEstigation) study, a population-based case-control study of breast cancer conducted in two German study regions, Hansestadt Hamburg and Rhine-Neckar-Karlsruhe (RNK) region. Participants were identified through participating clinics and the Hamburg cancer registry between January 1st, 2001 and September 30th, 2005 in Hamburg and between August 1st, 2002 and July 31st, 2005 in the RNK study region. Patients were aged 50-74 years at histologically confirmed primary invasive (stages I to IV) or in situ breast tumor (stage 0). Comprehensive information on demographic, socio-economic, and lifestyle factors was collected at multiple time points: at recruitment by a standardized face-to-face interview and at follow-up median 6 years as well as 11 years later using computer assisted telephone interview.

Vital status was assessed in 2009 and again in 2015 via the population registries and causes of death were obtained from death certificates and coded according to the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10).

Information on the clinical course was abstracted from medical records to verify clinical events either self-reported in follow-up interviews or reported by treating physicians.

The studies were approved by the ethics committee of the University of Heidelberg and the University of Hamburg and conducted in agreement with the Helsinki Declaration. Written informed consent was provided by all participants at baseline and during follow-up.

The primary objectives of this study are

* To assess the association of modifiable lifestyle factors and personal factors, including BMI, diet, physical activity, tobacco and alcohol use, menopausal hormone therapy, socioeconomic status, with breast cancer survival, overall and according to tumor type, after accounting for established prognostic factors.
* To examine the influence of genetic variants on breast cancer relapse and survival
* To assess the association of lifestyle factors and their changes in the course of survivorship on subsequent breast cancer prognosis.
* To assess the individual and combined association of inflammation/metabolic biomarkers as well as changes in their serum levels with subsequent breast cancer prognosis overall and according to tumor type.
* To assess whether and to what extent the associations between breast cancer prognosis and lifestyle factors and/or their changes are mediated by circulating biomarker levels.

Nonfasting serum or plasma samples provided at recruitment and follow-up by the patients are stored at -80°C.

Influence of Lifestyle, Inflammatory Biomarkers, and Genetic Factors on Long-term Breast Cancer Prognosis

The Influence of Lifestyle and Genetic Risk Factors, Circulating Inflammatory Biomarkers and Menopausal Hormone Therapy on Long-term Prognosis After Postmenopausal Breast Cancer

Risk of mortality (all-cause, breast cancer specific)

German Cancer Research Center

Nutritional and Metabolic Diseases

Rare Diseases

Obesity

Body Weight

Weight Gain

Chronic Disease

Disease Attributes

Body Weight Changes

Chronic Graft Versus Host Disease

Participants randomized to the Community Garden Intervention Group will receive the garden intervention. Participants will be assigned a plot for one season and will receive a standard package of services and amenities to support participation in the community garden, including seeds and transplants, tools, new garden classes and access to master community gardeners in Denver.

The non-gardening group will remain on the DUG wait lists and will not receive the garden intervention.

The investigators will recruit 30 prospective gardeners who have not been gardening for the past two years and who are listed on Denver Urban Gardens (DUG) wait lists. DUG randomly assigns people on each garden wait list to available plots, using a lottery. This creates a natural randomized experiment. Participants randomized to the garden intervention will receive a standardized garden resource package, which includes the following:

1. A garden plot in a Denver Urban Garden
2. Seeds and plant starts
3. Introductory gardening workshop
4. Social events including garden-specific events and garden mentoring.

The non-gardening group will remain on the DUG wait lists and will not receive these resources.

Duration of the intervention is 1 year.

Community Garden Intervention

Jill S Litt, PhD

An interdisciplinary team with extensive garden study experience conducted a pilot randomized controlled clinical trial to see whether gardening reduced risk factors for diseases like cancer and heart disease. The pilot trial will provide preliminary data on associations between human microbiome, diet, physical activity, and social interactions and the outcomes of weight status and key inflammatory biomarkers.

The pilot study will lead to development of a future, large randomized controlled clinical trial, by fulfilling the following aims:

Pilot Aim 1: Demonstrate feasibility of recruitment and ability to perform study procedures.

Pilot Aim 2: Demonstrate the ability to measure accurately chronic disease risk factors such as diet, physical activity, weight gain, microbiome characteristics and inflammatory biomarkers.

Pilot Aim 3: Provide preliminary results on the efficacy of gardens as a preventive intervention, and estimates for a detailed power analysis for the proposed subsequent larger trial.

Aim 3a: Demonstrate that compared to non-gardeners, gardeners have 1) greater intake of fruits and vegetables; 2) better Healthy Eating Index (HEI); 3) lower Diet Inflammatory Index (DII); 4) reduced sedentary time and increased moderate-to-vigorous physical activity (MVPA); and reduced age-associated weight gain.

Aim 3b: For gardeners and non-gardeners, sample garden soil, gut, skin, and oral microbiome at six time points from April through September to characterize and compare bacterial load, pathogenic taxa, taxonomic diversity, relative dominance, indicator taxa, and metabolomic results.

Aim 3c: Demonstrate that gardening reduces inflammatory biomarkers linked to heart disease and cancer, including CRP, IL1b, IL4, IL6, IL10, and TNFa, and that the effect of gardening is mediated by diet, weight gain, physical activity and characteristics of the microbiome.

Denver Garden Environment and Microbiome Study Disease

A Pilot Randomized Controlled Trial of Gardening as an Intervention to Reduce Risk of Cancer and Heart

6 24-hour diet recalls will be collected at random

Accelerometers will be adhered to thigh and collect data for 7 days

Microbiome data will be collected six time points using 1 gut, 2 skin, and 1 oral samples

Objective measurements of weight will be collected

Objective measurement of waist circumference

Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples

Samples include hs-CRP, TNF-alpha, IL1b, IL4, IL6, IL10

Including LDL, HDL, total cholesterol, triglycerides

University of Colorado, Boulder

Associate Professor, Environmental Studies

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Fistula

Pancreatic Fistula

Pathological Conditions, Anatomical

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Digestive System Fistula

Pancreatic Cancer

Surgical Drain Management

Particularly, pancreatic fistula is the most common and serious complication after pancreaticoduodenectomy (PD) and is reported in up to 40% of cases. The aim of this retrospective single-center study was to investigate the utility of the combination of preoperative inflammation biomarkers (PIBs) with postoperative day 1 drains amylase (POD1-d.a.) levels in predicting grade C Pancreatic Fistula (PF).

Data from a prospective collected database of 317 consecutive PDs performed at the University Campus Bio-Medico di Roma during the years 2005-2019, have been retrospectively analyzed. Local Ethical Committee approved the study.

Patients undergoing PD for periampullary neoplasms were included in the study. All patients underwent to PD with pancreaticojejunostomy reconstruction. Two surgical drains were always placed at the end of the surgery.

Data regarding PIBs, as full blood count including white blood cell (WBC) count, lymphocytes, neutrophils and platelets counts, neutrophil-to-lymphocyte ratio (NLR), derived neutrophil-to-lymphocyte ratio (d-NLR), platelet-to-lymphocyte ratio (PLR) and POD1-d.a. levels were collected and Positive Predictive Values (PPV) and Negative Predictive Values (NPV) were computed to investigate the probability to develop PF combining PIBs and drains amylase values.

Preoperative Inflammatory Biomarkers and Postoperative Day 1 Drain Amylase Value Predict Pancreatic Fistula After Pancreaticoduodenectomy

Preoperative Systemic Inflammatory Biomarkers and Postoperative Day 1 Drain Amylase Value Predict Grade C Pancreatic Fistula After Pancreaticoduodenectomy: a Retrospective Single Center Experience

Predictive Values (PPV) and Negative Predictive Values (NPV) were computed to investigate the probability to develop Pancreatic Fistula (PF) combining PIBs and Postoperative Day 1 Drain Amylase Value

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Influence of Lifestyle, Inflammatory Biomarkers, and Genetic Factors on Long-term Breast Cancer Prognosis	NCT03401034	Breast Cancer Breast Cancer M... Breast Cancer S... Postmenopausal ... Lifestyle Genetic Factors Inflammation Inflammatory Bi... Hormone Therapy Phytoestrogens		50 Years - 74 Years	German Cancer Research Center
Denver Garden Environment and Microbiome Study Disease	NCT03089151	Diet Modificati... Physical Activi... Weight Gain Chronic Disease Lifestyle, Sede... Health Behavior	Community Garde...	18 Years -	University of Colorado, Boulder
Preoperative Inflammatory Biomarkers and Postoperative Day 1 Drain Amylase Value Predict Pancreatic Fistula After Pancreaticoduodenectomy	NCT04361682	Pancreatic Fist... Pancreas Cancer Inflammatory Re...	Surgical Drain ...	18 Years - 80 Years	Campus Bio-Medico University

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