- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04987424
Prevalence of Lymphedema in Valle Del Cauca, Colombia.
Prevalence Of Upper Limb Lymphedema In Patients Diagnosed With Breast Cancer In A Valle Del Cauca Oncology Institution In A 2008-2020 Cohort In Colombia.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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 .
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Valle Del Cauca
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Cali, Valle Del Cauca, Colombia, 760042
- Hematoncologos S.A
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Prevalence of lymphedema
Tidsramme: 2014-2020
|
Determining the prevalence of lymphedema in patients diagnosed with unilateral breast cancer
|
2014-2020
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk Factors
Tidsramme: 2014-2020
|
Determining risk factors for the development of lymphedema in patients diagnosed with unilateral breast cancer
|
2014-2020
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CER2021
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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