The Tetrad BMI, Leptin, Leptin/Adiponectin (L/A) Ratio an... | NCT01643148

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

NCT01643148

Sponsor

Materno-Perinatal Hospital of the State of Mexico

Status

Completed

Last Update Posted

Jul 18, 2012Estimated

Enrollment

88Actual

Phase

Not provided

Conditions

Female Breast Carcinoma

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Jul 2012Actual

First Submitted Date

Jul 16, 2012

First Submission Date that Met QC Criteria

Jul 17, 2012

First Posted Date

Jul 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2012

Last Update Posted Date

Jul 18, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hugo Mendieta Zeron, PhD, Materno-Perinatal Hospital of the State of MexicoPrincipal Investigator

Lead Sponsor

Materno-Perinatal Hospital of the State of MexicoOTHER

Collaborators

Name	Class
Universidad Autonoma del Estado de Mexico	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
breast cancer patients (cases)		36 subjects
controls		36 subjects

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients with hormonal therapy.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 Years

Standard Ages

Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23292756	Derived	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.

ID	Term
D001943	Breast Neoplasms
C536137	Medullary cystic kidney disease 1

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases