The Tetrad BMI, Leptin, Leptin/Adiponectin (L/A) Ratio and CA-15-3 is a Reliable Biomarker of Breast Cancer (leptin)

This study has been completed.
Sponsor:
Collaborator:
Universidad Autonoma del Estado de Mexico
Information provided by (Responsible Party):
Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico
ClinicalTrials.gov Identifier:
NCT01643148
First received: July 16, 2012
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

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.


Condition
Female Breast Carcinoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Phase 1. Collect Samples of Breast Biopsy Patients Treated at the Hospital Radiology Service Maternal Perinatal Monica Pretelini

Resource links provided by NLM:


Further study details as provided by Materno-Perinatal Hospital of the State of Mexico:

Biospecimen Retention:   None Retained

serum


Enrollment: 88
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
breast cancer patients (cases)
36 subjects
controls
36 subjects

Detailed 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).

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Cross-sectional prospective study conducted at the Maternal-Perinatal Hospital "Mónica Pretelini" (HMPMP), State of Mexico Health Institute (ISEM), Toluca, Mexico, from January to October 2011.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with hormonal therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643148

Sponsors and Collaborators
Materno-Perinatal Hospital of the State of Mexico
Universidad Autonoma del Estado de Mexico
Investigators
Principal Investigator: Jonnathan Guadalupe Santillán Benítez, MSc Autonomus University Of the State Of México
Study Director: Leobardo Manuel Gómez Oliván, PhD Universidad Autonoma del Estado de Mexico
Study Chair: Hugo Mendieta Zeron, PhD Autonomous University of the State of Mexico
  More Information

No publications provided by Materno-Perinatal Hospital of the State of Mexico

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hugo Mendieta Zeron, PhD, Materno-Perinatal Hospital of the State of Mexico
ClinicalTrials.gov Identifier: NCT01643148     History of Changes
Other Study ID Numbers: DCQ
Study First Received: July 16, 2012
Last Updated: July 17, 2012
Health Authority: Mexico: Secretaria de Salud

Keywords provided by Materno-Perinatal Hospital of the State of Mexico:
biomarker
BMI
breast cancer
CA-15-3
leptin

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 17, 2014