NCT03401034

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,813

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2002

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

12.9 years

First QC Date

January 8, 2018

Last Update Submit

January 15, 2018

Conditions

Breast CancerBreast Cancer MortalityBreast Cancer SurvivalPostmenopausal Breast CancerLifestyleGenetic FactorsInflammationInflammatory BiomarkersHormone TherapyPhytoestrogens

Outcome Measures

Primary Outcomes (1)

  • Mortality after breast cancer diagnosis

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

    Median follow-up time 6 and 11 years

Secondary Outcomes (1)

  • Risk of recurrence

    Median follow-up time 6 and 11 years

Eligibility Criteria

Age50 Years - 74 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with histologically confirmed primary invasive or in situ breast tumors aged 50-74 years at diagnosis recruited in the city and state of Hamburg or the Rhine-Neckar-Karlsruhe region

You may qualify if:

  • Histologically confirmed Primary invasive (ICD-10 C50) (stage I-IV) or in-situ (ICD-10 D05) breast cancer
  • to 74 years at diagnosis
  • Patients in the city and state of Hamburg in northern Germany and the Rhine-Neckar-Karlsruhe region in southern Germany
  • German-speaking
  • Physically and mentally ability to participate in a personal interview of about 90 minutes

You may not qualify if:

  • Previous diagnosis of breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Breast NeoplasmsInflammation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jenny Chang-Claude, Prof. Dr.

    German Cancer Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 17, 2018

Study Start

August 1, 2002

Primary Completion

June 30, 2015

Study Completion

June 30, 2015

Last Updated

January 17, 2018

Record last verified: 2018-01