Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304941
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-03-17
Brief Title:
Insulin Resistance and Breast Cancer
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Breast Cancer and Insulin Resistance Implications for Preventive Counseling in Familial and Sporadic Cases
Status:
COMPLETED
Status Verified Date:
2010-09-17
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will characterize risk factors associated with breast cancer development in some patients In particular it will examine the role of insulin in breast cancer in patients with and without a family history of the disease
Women 30 to 70 years old who have been diagnosed with breast cancer and matched control healthy subjects with and without a family history of breast cancer may be eligible for this study
Participants undergo the following procedures
Cancer-genetic counseling session including family history risk assessment genetic testing for BRCA1 and BRCA2 if criteria is met interpretation of results and management options
Medical history including questions about symptoms or diseases reproductive history use of oral contraceptives body weight exercise lifestyle and demographic issues
Drawing of family tree
Examination of medical records
Blood drawing for genetic and other tests
CT scan of the abdomen approximate time 1 minute
Filling out questionnaires
Women 30 to 70 years old who have been diagnosed with breast cancer and matched control healthy subjects with and without a family history of breast cancer may be eligible for this study
Participants undergo the following procedures
Cancer-genetic counseling session including family history risk assessment genetic testing for BRCA1 and BRCA2 if criteria is met interpretation of results and management options
Medical history including questions about symptoms or diseases reproductive history use of oral contraceptives body weight exercise lifestyle and demographic issues
Drawing of family tree
Examination of medical records
Blood drawing for genetic and other tests
CT scan of the abdomen approximate time 1 minute
Filling out questionnaires
Detailed Description:
The etiology of breast cancer is still poorly understood with known risk factors explaining only a small proportion of cases Risk factors that modulate the development of breast cancer include age geographic location socioeconomic status reproductive events exogenous hormones lifestyle familial history of breast cancer mammographic density history of benign breast disease ionizing radiation and bone density
Several lines of evidence have demonstrated that insulin and the insulin receptor play a key role in the formation and progression of breast cancer Insulin has direct and indirect effects on breast cancer direct effects as a growth promoting factor and indirect effects through actions on other hormones involved in breast cancer In addition certain conditions associated with insulin resistance such as obesity and abdominal fat are known risk factors for breast cancer
Family history of breast cancer is also a well established major risk factor To date both genetic and non-genetic factors have been suggested to influence breast cancer risk in women with a positive family history of breast cancer including those with recognized mutations in the BRCA1 and BRCA2 genes Women with a family history of breast cancer inherit a susceptibility to the condition the development of the disease requires a series of promoting steps including lifestyle diet and environmental factors Several hormones involved in breast cancer such as IGF-1 testosterone and SHBG are affected by a positive family history of breast cancer Also women with a high Waist-to-Hip ratio WHR and a positive family history of breast cancer are at higher risk of developing breast cancer than those women with a high WHR without a positive family history The role of insulin and insulin-related factors in women with a family history of breast cancer has not been examined
There is growing recognition that insulin may be a potential mediator of breast cancer The above evidence suggests that actions of insulin may be involved in the promoting steps that predispose some women to breast cancer These findings provide the biological basis for insulin related factors to serve as potential targets for breast cancer prevention and risk assessment
The main goal of this proposal is to unravel the contributions of insulin and insulin-related actions eg insulin resistance abdominal fat on breast cancer risk The purpose of the present study is to characterize the role of insulin in newly diagnosed premenopausal and postmenopausal women with and without a family history of breast cancer The objective is to assess the relative strength of each risk factor associated with insulin actions and their individual impact on breast cancer This study will provide data that may serve as the basis for future studies on preventive strategies targeted at lowering insulin levels and increasing insulin sensitivity eg decrease glucose decrease abdominal fat decrease omega-6 fatty acidsincrease omega-3 fatty acids increase fiber intake increase exercise in a subset of patients
This protocol will recruit only female patients and will concentrate only on breast cancer risk Subjects will be asked to complete several questionnaires in the course of genetic counseling to provide information on medical and reproductive history demographics risk factors physical activity as well as other information needed to establish an appropriate sample for the study Genetic testing will be offered as part of the initial evaluation and to check for BRCA12 mutation status
Several lines of evidence have demonstrated that insulin and the insulin receptor play a key role in the formation and progression of breast cancer Insulin has direct and indirect effects on breast cancer direct effects as a growth promoting factor and indirect effects through actions on other hormones involved in breast cancer In addition certain conditions associated with insulin resistance such as obesity and abdominal fat are known risk factors for breast cancer
Family history of breast cancer is also a well established major risk factor To date both genetic and non-genetic factors have been suggested to influence breast cancer risk in women with a positive family history of breast cancer including those with recognized mutations in the BRCA1 and BRCA2 genes Women with a family history of breast cancer inherit a susceptibility to the condition the development of the disease requires a series of promoting steps including lifestyle diet and environmental factors Several hormones involved in breast cancer such as IGF-1 testosterone and SHBG are affected by a positive family history of breast cancer Also women with a high Waist-to-Hip ratio WHR and a positive family history of breast cancer are at higher risk of developing breast cancer than those women with a high WHR without a positive family history The role of insulin and insulin-related factors in women with a family history of breast cancer has not been examined
There is growing recognition that insulin may be a potential mediator of breast cancer The above evidence suggests that actions of insulin may be involved in the promoting steps that predispose some women to breast cancer These findings provide the biological basis for insulin related factors to serve as potential targets for breast cancer prevention and risk assessment
The main goal of this proposal is to unravel the contributions of insulin and insulin-related actions eg insulin resistance abdominal fat on breast cancer risk The purpose of the present study is to characterize the role of insulin in newly diagnosed premenopausal and postmenopausal women with and without a family history of breast cancer The objective is to assess the relative strength of each risk factor associated with insulin actions and their individual impact on breast cancer This study will provide data that may serve as the basis for future studies on preventive strategies targeted at lowering insulin levels and increasing insulin sensitivity eg decrease glucose decrease abdominal fat decrease omega-6 fatty acidsincrease omega-3 fatty acids increase fiber intake increase exercise in a subset of patients
This protocol will recruit only female patients and will concentrate only on breast cancer risk Subjects will be asked to complete several questionnaires in the course of genetic counseling to provide information on medical and reproductive history demographics risk factors physical activity as well as other information needed to establish an appropriate sample for the study Genetic testing will be offered as part of the initial evaluation and to check for BRCA12 mutation status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-CH-0119 | None | None | None |