MDACC Study Summary 2006-0139

Study Summary
No. 2006-0139:.......Breast......Janice Chilton......Health Disparities Research

Study Summary Title



Study Summary Number:	2006-0139

Study Title:	A Comparision of hormone levels and dietary habits among African American and West African Women in Houston, TX and West African Women in Ibadan, Nigeria

Physician

New Patient Referral



Name:	Janice Chilton	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Health Disparities Research	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2764 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Blood draws for this study will be done during regular clinic visits and will coincide with routine blood draws for patients. Blood draws (40 ml) will be collected at baseline <17 weeks) and near the time of birth of the child.

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this research study is to learn more about the hormone levels and dietary habits of African American women, West African women in Houston, Texas, and West African women in Ibadan, Africa. Researchers in the Texas-Nigeria Sisters Taking Action to Reduce Risk (TX-STARR) project want to learn if these factors may be linked to breast cancer risk in these groups of women.

Study Objectives / Outcomes

Primary Objective

To determine if there is a difference in mean serum levels of NPBE2 in women taken during the first trimester and 24 hours after birth between African Americans in Houston, West Africans living in Houston and West Africans living in Ibadan Nigeria.

Secondary Objectives

To determine if there is a difference in nutrient intake among pregnant African Americans in Houston, West Africans living in Houston, and West Africans living in Ibadan Nigeria (measured by food record).

To determine if there is a difference in mean serum levels of estrone, estradiol, and SHBG in women taken during the first trimester and 24 hours after birth between African Americans in Houston, West Africans living in Houston and West Africans living in Ibadan Nigeria.

To determine if there is a correlation between nutrient intake and mean serum levels of hormones during pregnancy overall or among the different cultural/geographic groups.

To determine if there is a correlation between nutrient intake and mean serum levels of hormones 24 hours after birth overall or among the different cultural/geographic groups.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	04/19/2006

Study Type:	Other

Recruitment Status:	Open

Projected Accrual:	370

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Women who are less than or equal to17 weeks pregnant at time of first clinic visit (study enrollment)

2) Women who have had less than or equal to 2 full term pregnancies resulting in a live birth

3) Women whose current pregnancy will result in a single birth

4) Women aged 16 to 37 at time of first clinic visit (study enrollment)

5) Women who are self-identified as African American or West African

Exclusion Criteria:

1) Women who took hormonal birth control at time of conception

2) Women currently taking medications that affect estrogen levels including certain thyroid, lipid lowering, or hypertensive medications

3) Women with any of the following health conditions: diabetes (overt or gestational), hypoglycemia, hepatitis, tuberculosis, meningitis, pneumonia, hypothyroidism or hyperthyroidism, rubella, celiac disease, pancreatitis, steatorrhea, prolonged diarrhea, Crohn's disease, idiopathic sprue, dumping syndrome-in active or recovery stages, heart disease, hypertension, hypotension, renal disease, liver disease, lupus erythematosus, sickle cell disease, malignancy, acquired immune deficiency syndrome (AIDS), mental retardation

Links

Registration Number: Not Applicable Clinical Trial