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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Breast Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014