NCT01643148

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

9 months

First QC Date

July 16, 2012

Last Update Submit

July 17, 2012

Conditions

Keywords

biomarkerBMIbreast cancerCA-15-3leptin

Study Arms (2)

breast cancer patients (cases)

36 subjects

controls

36 subjects

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Patients with hormonal therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Biospecimen

Retention: NONE RETAINED

serum

MeSH Terms

Conditions

Breast NeoplasmsMedullary cystic kidney disease 1

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jonnathan Guadalupe Santillán Benítez, MSc

    Autonomus University Of the State Of México

    PRINCIPAL INVESTIGATOR
  • Leobardo Manuel Gómez Oliván, PhD

    Universidad Autonoma del Estado de Mexico

    STUDY DIRECTOR
  • Hugo Mendieta Zeron, PhD

    Autonomous University of the State of Mexico

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 16, 2012

First Posted

July 18, 2012

Study Start

January 1, 2011

Primary Completion

October 1, 2011

Study Completion

July 1, 2012

Last Updated

July 18, 2012

Record last verified: 2012-07