Female Breast CarcinomaleptinNCT01643148
The Tetrad BMI, Leptin, Leptin/Adiponectin (L/A) Ratio and CA-15-3 is a Reliable Biomarker of Breast Cancer
An observational study of Female Breast Carcinoma, run by Materno-Perinatal Hospital of the State of Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Female Breast Carcinoma
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- 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.
Who may be able to join
- Female patients attending mammography, average age of the fourth and fifth decades.
Who cannot join
- Patients with hormonal therapy.
About this study
Official title: Phase 1. Collect Samples of Breast Biopsy Patients Treated at the Hospital Radiology Service Maternal Perinatal Monica Pretelini
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.
Read more
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.
Read the 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).
- Conditions
- Female Breast Carcinoma
- Keywords
- biomarker, BMI, breast cancer, CA-15-3, leptin
- Medical subject headings
- Breast Neoplasms, Medullary cystic kidney disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| breast cancer patients (cases) | 36 subjects | |
| controls | 36 subjects |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJan 2011
- Primary completionOct 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materno-Perinatal Hospital of the State of Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma del Estado de Mexico
- Responsible party
- Principal investigator, Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico
- Investigators
- Jonnathan Guadalupe Santillán Benítez, MSc, Principal investigator, Autonomus University Of the State Of MéxicoLeobardo Manuel Gómez Oliván, PhD, Study director, Universidad Autonoma del Estado de MexicoHugo Mendieta Zeron, PhD, Study chair, Autonomous University of the State of Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643148
- Sponsor's protocol ID
- DCQ
- Acronym
- leptin
- Status last verified
- Jul 2012
- First submitted
- 16 Jul 2012
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23292756
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1. Collect Samples of Breast Biopsy Patients Treated at the Hospital Radiology Service Maternal Perinatal Monica Pretelini
- ClinicalTrials.gov ID
- NCT01643148
- Acronym / sponsor ID
- leptin / DCQ
- Conditions
- Female Breast Carcinoma
- Keywords
- biomarker, BMI, breast cancer, CA-15-3, leptin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Materno-Perinatal Hospital of the State of MexicoUniversity, hospital or other
- Collaborators
- Universidad Autonoma del Estado de Mexico
- Study start
- Jan 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breast cancer patients (cases) | – | –36 subjects |
| controls | – | –36 subjects |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Female patients attending mammography, average age of the fourth and fifth decades.
Key exclusion criteria (1 listed)
- Patients with hormonal therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
- Derived from this study: PubMed 23292756Santillan-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.
Related trials for Female Breast Carcinoma
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonnathan Guadalupe Santillán Benítez, MSc principal investigator
Autonomus University Of the State Of México
Leobardo Manuel Gómez Oliván, PhD study director
Universidad Autonoma del Estado de Mexico
Hugo Mendieta Zeron, PhD study chair
Autonomous University of the State of Mexico
Questions about this trial
What is this clinical trial studying?
An observational study of Female Breast Carcinoma, run by Materno-Perinatal Hospital of the State of Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01643148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.