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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01643148
Other study ID # DCQ
Secondary ID
Status Completed
Phase N/A
First received July 16, 2012
Last updated July 17, 2012
Start date January 2011
Est. completion date July 2012

Study information

Verified date July 2012
Source Materno-Perinatal Hospital of the State of Mexico
Contact n/a
Is FDA regulated No
Health authority Mexico: Secretaria de Salud
Study type Observational

Clinical Trial Summary

Objective:

Evaluate body mass index (BMI), leptin, Leptin/adiponectin (L/A) ratio and cancer antigen (CA) 15-3 together as reliable biomarkers for breast cancer.

Patients:

Consecutive patients aged between 40 - 60 years, with breast disease and informed consent.

Interventions:

Patients' Anthropometric and laboratorial characteristics classified by BMI in the group of cancer and patients with benign breast disease as well as biochemical tests of leptin, adiponectin,CA 15-3, hemoglobin, glucose low-density lipoprotein cholesterol (LDLC), high-density lipoprotein cholesterol (HDLC) levels were obtained as well as a blood sample to analyze CA 15-3 levels with a electrochemiluminescence immunoassay.

Hypothesis:

Using together leptin, L/A ratio, CA 15-3 and BMI could offer a reliable approach to detect high risk women to develop breast cancer.


Description:

Serum levels of leptin, adiponectin and CA 15-3, as well as anthropometric and biochemical parameters were analyzed in 88 female patients attending mammography study. Predictive values of BMI, leptin, L/A ratio and CA 15-3 were determined with 95% confidence interval (CI).


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date July 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria:

- Female patients attending mammography, average age of the fourth and fifth decades.

Exclusion Criteria:

- Patients with hormonal therapy.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Materno-Perinatal Hospital of the State of Mexico Universidad Autonoma del Estado de Mexico
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