Breast CancerNCT03401034
Influence of Lifestyle, Inflammatory Biomarkers, and Genetic Factors on Long-term Breast Cancer Prognosis
An observational study of Breast Cancer and Breast Cancer Mortality, run by German Cancer Research Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 years, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Mortality, Breast Cancer Survival
- How many people
- 3,813 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2002to 30 Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- Women only
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Previous diagnosis of breast cancer
About this study
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).
Read more
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.
- Conditions
- Breast Cancer, Breast Cancer Mortality, Breast Cancer Survival, Postmenopausal Breast Cancer, Lifestyle, Genetic Factors
- Medical subject headings
- Breast Neoplasms, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality after breast cancer diagnosis
Risk of mortality (all-cause, breast cancer specific)
Measured: Median follow-up time 6 and 11 years
Secondary outcomes (1)
Risk of recurrence
Risk of recurrence
Measured: Median follow-up time 6 and 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Aug 2002
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,813 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenny Chang-Claude, Prof. Dr., Principal investigator, German Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401034
- Sponsor's protocol ID
- GermanCRC_ID76
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03401034
- Acronym / sponsor ID
- GermanCRC_ID76
- Conditions
- Breast Cancer, Breast Cancer Mortality, Breast Cancer Survival, Postmenopausal Breast Cancer, Lifestyle, Genetic Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,813 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Study start
- 1 Aug 2002 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Previous diagnosis of breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality after breast cancer diagnosis
Time frame: Median follow-up time 6 and 11 years
Risk of mortality (all-cause, breast cancer specific)
1 secondary outcome
Risk of recurrence
Time frame: Median follow-up time 6 and 11 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Chang-Claude, Prof. Dr. principal investigator
German Cancer Research Center
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Cancer Mortality, run by German Cancer Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality after breast cancer diagnosis (time frame: Median follow-up time 6 and 11 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.