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

January 15, 2018 updated by: German Cancer Research Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3813

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability 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

Description

Inclusion Criteria:

  • Histologically confirmed Primary invasive (ICD-10 C50) (stage I-IV) or in-situ (ICD-10 D05) breast cancer
  • 50 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

Exclusion Criteria:

  • Previous diagnosis of breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality after breast cancer diagnosis
Time Frame: Median follow-up time 6 and 11 years
Risk of mortality (all-cause, breast cancer specific)
Median follow-up time 6 and 11 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Risk of recurrence
Time Frame: Median follow-up time 6 and 11 years
Risk of recurrence
Median follow-up time 6 and 11 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
German Cancer Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jenny Chang-Claude, Prof. Dr., German Cancer Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GermanCRC_ID76

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings