Prevalence of Lymphedema in Valle Del Cauca, Colombia.

NCT ID: NCT04987424

Last Updated: 2021-08-09

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

UNKNOWN

Total Enrollment

367 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-18

Study Completion Date

2021-12-31

Brief Summary

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This is an epidemiological cross-sectional study aiming to determine the prevalence of lymphedema and the incidence of risk factors in patients diagnosed with unilateral breast cancer in a cohort from 2008 to 2020 in a specialised oncology centre in Valle del Cauca, Colombia.

Detailed Description

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CONTEXT: Breast cancer-associated lymphedema is considered one of the most frequent side effects of breast cancer therapy. (1,2) Despite the abundant information available worldwide on epidemiology and risk factors, little is known about these data in Colombia and Latin America.

OBJECTIVE: To determine the actual prevalence and incidence of risk factors for the development of lymphedema associated with breast cancer in a specialised oncology centre in Valle del Cauca, Colombia.

DESIGN, SETTING, AND PATIENTS: Between 2008 and 2020 a sample of 367 patients with a diagnosis of unilateral breast cancer was established, with which a descriptive study was carried out, in which a series of anthropometric measurements were taken of the upper limbs in order to obtain the volume of both arms and determine the prevalence of lymphedema using the formula of truncated volumes of the Spanish society of lymphology, after which the medical records were reviewed in order to collect other data of interest. Patients were excluded if they had bilateral breast cancer or direct trauma to the upper limb.

INTERVENTIONS: A single intervention was carried out in which the patients were summoned for an interview and anthropometric measurements of the upper limbs, thus calculating the arm volume for a lymphedema primary diagnosis .

Conditions

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Unilateral Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Development and validation of Lymphedema levels diagnostic

A single intervention was carried out in which the patients were summoned for an interview and anthropometric measurements of the upper limbs, thus calculating the arm volume for a lymphedema primary diagnosis .

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Unilateral breast cancer, cancer diagnosis between 2008-2020 in the oncology institution Colombia

Exclusion Criteria

* Moving to a different institution for attention (other than Hemato-Oncólogos SA), unwillingness to become volunteer and death, bilateral breast cancer, congenital disease or trauma in the upper limb.
Minimum Eligible Age

18 Years

Maximum Eligible Age

98 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hematooncologos S.A.

UNKNOWN

Sponsor Role collaborator

Grupo de investigación C.E.R

OTHER

Sponsor Role lead

Responsible Party

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Maria Isabel Cadena

Cirujana Plástica Estética, Reconstructiva y Microcirugía

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hematoncologos S.A

Cali, Valle del Cauca Department, Colombia

Site Status

Countries

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Colombia

References

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Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

Reference Type BACKGROUND
PMID: 25220842 (View on PubMed)

Related Links

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https://hematooncologos.com/

Hematooncologos web page

Other Identifiers

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CER2021

Identifier Type: -

Identifier Source: org_study_id

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