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

NCT ID: NCT01643148

Last Updated: 2012-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Female Breast Carcinoma

Keywords

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biomarker BMI breast cancer CA-15-3 leptin

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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breast cancer patients (cases)

36 subjects

No interventions assigned to this group

controls

36 subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with hormonal therapy.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad Autonoma del Estado de Mexico

OTHER

Sponsor Role collaborator

Materno-Perinatal Hospital of the State of Mexico

OTHER

Sponsor Role lead

Responsible Party

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Hugo Mendieta Zeron

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonnathan Guadalupe Santillán Benítez, MSc

Role: PRINCIPAL_INVESTIGATOR

Autonomus University Of the State Of México

Leobardo Manuel Gómez Oliván, PhD

Role: STUDY_DIRECTOR

Universidad Autonoma del Estado de Mexico

Hugo Mendieta Zeron, PhD

Role: STUDY_CHAIR

Autonomous University of the State of Mexico

References

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Santillan-Benitez JG, Mendieta-Zeron H, Gomez-Olivan LM, Torres-Juarez JJ, Gonzalez-Banales JM, Hernandez-Pena LV, Ordonez-Quiroz A. The tetrad BMI, leptin, leptin/adiponectin (L/A) ratio and CA 15-3 are reliable biomarkers of breast cancer. J Clin Lab Anal. 2013 Jan;27(1):12-20. doi: 10.1002/jcla.21555. Epub 2013 Jan 4.

Reference Type DERIVED
PMID: 23292756 (View on PubMed)

Other Identifiers

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DCQ

Identifier Type: -

Identifier Source: org_study_id