This study is currently not recruiting participants.

Influence of breast cancer and bone metastases on development of diabetes.

Investigating the Relationship Between Breast Cancer Treatments and Diabetes Development

Not Recruiting
40 years - 100 years
Female

Brief description of study.

Breast cancer is the most common invasive cancer in American women. Both bone metastases and medications used to treat breast cancer such as aromatase inhibitors may have adverse effects on bone health resulting in risk of fracture.  Bone released factors such as TGF beta contribute to muscle weakness, and impaired insulin secretion which could predispose to development of diabetes in these women. Type 2 diabetes is one of the most common chronic diseases and has been associated with higher incidence and aggressiveness of a variety of cancers, including breast cancer.   However it remains uncertain the frequency in which patients with new diagnosis of breast cancer with or without bone metastases develop new diagnosis of diabetes, and the influence of hormonal therapies for breast cancer, or of bone directed therapies (such as bisphosphonates) on development of new diabetes in this population.
We propose an electronic health records (EHR) and medical informatics approach to identifying the incidence of new diagnoses of diabetes among breast cancer patients and the influence of bone metastases, comorbidities, and various cancer and bone related medications on progression to diabetes, compared to controls. 
In particular this protocol will require the resources of the Regenstrief Institute Data Core, and the Indiana Network for Patient Care, along with the Indiana Department of Health State Cancer Registry to create a deidentified retrospective cohort of breast cancer patients and controls matching on age, race, and sex for the analysis.  Data from the Indiana Department of Health State Cancer Registry will enable us to classify with certainty breast cancer cases, which will then be analyzed based on data within INPC.
In summary, we will use EHR and Medical Informatics to phenotype breast cancer cases and controls using combinations of ICD codes, test records, medications, death records, and natural language processing (NLP; data extraction from text reports) and other information from the Indiana Network for Patient Care (INPC) encompassing a database from multiple clinical data sources in central Indiana organized and integrated by the Regenstrief Institute.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer, Diabetes, Healthy
  • Age: 40 years - 100 years
  • Gender: Female

Inclusion Criteria

•    Eligibility for Breast cancer cases: Women age 40 and older from the above time period, with a new diagnosis of breast cancer (ICD9, ICD10, having no prior breast cancer codes in the preceding 2 years), and without evidence of diabetes during the previous 2 years before index date (ICD9, ICD10, diabetes medications, hyperglycemia or HgbA1c>6.5%).  Breast cancer diagnosis will be checked against the Indiana State Department of Health Cancer Registry.
•    Controls: Women age 40 and older from the above time period, that are age and race matched women (randomly selected) from the same data sources, without a diagnosis of breast cancer ever, and without evidence of diabetes during the previous 2 years before index date (ICD9, ICD10, diabetes medications, hyperglycemia, or HgbA1c>6.5%)

Exclusion criteria
•    Men
•    Diagnosis of other cancers (except non-melanoma skin cancers)
•    Absence of available EHR data within the above data sources.

This study investigates the connection between breast cancer treatments and the development of diabetes. Breast cancer is the most common invasive cancer in women, and treatments like aromatase inhibitors can affect bone health. This can lead to issues like muscle weakness and insulin problems, which may increase the risk of diabetes. The study will explore how often women with new breast cancer diagnoses develop diabetes, particularly focusing on those with bone metastases and the effects of hormonal and bone-directed therapies.

Participants will have their medical records analyzed using electronic health records and medical informatics. This includes reviewing ICD codes, test results, and medication records to understand the progression to diabetes. The study will use data from the Indiana Network for Patient Care, which combines information from various clinical sources, to ensure a comprehensive analysis.

  • Who can participate: Women aged 40 and older with a new diagnosis of breast cancer and no prior diabetes in the last 2 years are eligible. Controls are similar women without a breast cancer diagnosis or diabetes history.
  • Study details: Participants' health records will be analyzed to identify diabetes development. The study will use electronic health records and data from various clinical sources to gather information.
Updated on 19 Feb 2024. Study ID: 1901010237

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