Breast Cancer Clinical Trial
Official title:
The Influence of Lifestyle and Genetic Risk Factors, Circulating Inflammatory Biomarkers and Menopausal Hormone Therapy on Long-term Prognosis After Postmenopausal Breast Cancer
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.
n/a
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