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

Sponsor
Materno-Perinatal Hospital of the State of Mexico (Other)
Overall Status
Completed
CT.gov ID
NCT01643148
Collaborator
Universidad Autonoma del Estado de Mexico (Other)
88
Enrollment
18
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    88 participants
    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
    Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Oct 1, 2011
    Actual Study Completion Date :
    Jul 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    breast cancer patients (cases)

    36 subjects
    controls

    36 subjects

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      40 Years to 60 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Female patients attending mammography, average age of the fourth and fifth decades.
      Exclusion Criteria:
      • Patients with hormonal therapy.

      Contacts and Locations

      Locations

      No locations specified.

      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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Hugo Mendieta Zeron, PhD, Materno-Perinatal Hospital of the State of Mexico
      ClinicalTrials.gov Identifier:
      NCT01643148
      Other Study ID Numbers:
      • DCQ
      First Posted:
      Jul 18, 2012
      Last Update Posted:
      Jul 18, 2012
      Last Verified:
      Jul 1, 2012
      Keywords provided by Hugo Mendieta Zeron, PhD, Materno-Perinatal Hospital of the State of Mexico
      biomarker
      BMI
      breast cancer
      CA-15-3
      leptin
      Additional relevant MeSH terms:
      Breast Neoplasms

      Study Results

      No Results Posted as of Jul 18, 2012