Relationship Between Body Composition, Food Consumption, and Micro and Macronutrients With Gene Expression in Breast Cancer

NCT ID: NCT04389424

Last Updated: 2020-05-15

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2022-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The protocol involves measurement of 25 hidroxy vitamin D, gene expression of cytochrome and vitamin D receptor , endoxifen, tamoxifen, exemestane, and other metobolites related to nutrition and endocrine metabolism.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Endocrine Therapy Endocrine Therapy Adverse Reaction Vitamin D Deficiency Nutrition Disorders Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anastrozole

Breast cancer women with anastrozole treatment

Anastrozole

Intervention Type DRUG

Use of anastrozole for breast cancer recurrence prevention

Tamoxifen

Breast cancer women with tamoxifen treatment

Tamoxifen

Intervention Type DRUG

Use of tamoxifen for breast cancer recurrence prevention

Exemestane

Breast cancer women with exemestane treatment

Exemestane

Intervention Type DRUG

Use of exemestane for breast cancer recurrence prevention

Basal

Breast cancer women luminal type without any endocrine treatment (at initial diagnosis)

Basal

Intervention Type DIAGNOSTIC_TEST

Initial diagnosis of breast cacner by biopsy or mastectomy

Recurrence

Breast cancer women luminal type with recurrence of disease during endocrine therapy

Tamoxifen

Intervention Type DRUG

Use of tamoxifen for breast cancer recurrence prevention

Anastrozole

Intervention Type DRUG

Use of anastrozole for breast cancer recurrence prevention

Recurrence

Intervention Type DIAGNOSTIC_TEST

Breast cancer recurrence under endocrine therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tamoxifen

Use of tamoxifen for breast cancer recurrence prevention

Intervention Type DRUG

Exemestane

Use of exemestane for breast cancer recurrence prevention

Intervention Type DRUG

Anastrozole

Use of anastrozole for breast cancer recurrence prevention

Intervention Type DRUG

Basal

Initial diagnosis of breast cacner by biopsy or mastectomy

Intervention Type DIAGNOSTIC_TEST

Recurrence

Breast cancer recurrence under endocrine therapy

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Breast cancer initial diagnosis Breast cancer recurrence under endoctine therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Breast cancer women under endocrine therapy or recurrence of disease after endocrine therapy
* Signed consent

Exclusion Criteria

* Mental retardation
Minimum Eligible Age

18 Years

Maximum Eligible Age

98 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Guadalajara

OTHER

Sponsor Role collaborator

Instituto Jalisciense de Cancerologia

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto Jalisciense de Cancerologia

Guadalajara, Jalisco, Mexico

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

JOSE ALFONSO CRUZ RAMOS, MD

Role: CONTACT

1523314886313

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

JOSE ALFONSO CRUZ RAMOS, MD

Role: primary

1523314886313

Related Links

Access external resources that provide additional context or updates about the study.

http://www.ijc.gob.mx/

Instituto Jalisciense de Cancerología

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1/15

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.