Unilateral Breast CancerNCT04987424
Prevalence of Lymphedema in Valle Del Cauca, Colombia.
An observational study of Unilateral Breast Cancer, run by Grupo de investigación C.E.R at 1 site in Colombia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 98 years
- Conditions the study is for
- Unilateral Breast Cancer
- What is being tested?
- Development and validation of Lymphedema levels diagnostic
- How many people
- 367 participants
- Where
- 1 siteColombia
- Study dates
- 18 Jan 2018to 31 Dec 2021
- 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 18 to 98 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Between 2008 and 2020 a sample of 367 patients with a diagnosis of unilateral breast cancer was established
Who may be able to join
- Unilateral breast cancer, cancer diagnosis between 2008-2020 in the oncology institution Colombia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the detailed description
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
- Unilateral Breast Cancer
- Being tested
- Development and validation of Lymphedema levels diagnostic
- Keywords
- Lymphedema, breast cancer, prevalence, risk factors, epidemiology
- Medical subject headings
- Unilateral Breast Neoplasms, Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Development and validation of Lymphedema levels diagnosticDiagnostic test
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 .
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of lymphedema
Determining the prevalence of lymphedema in patients diagnosed with unilateral breast cancer
Measured: 2014-2020
Secondary outcomes (1)
Risk Factors
Determining risk factors for the development of lymphedema in patients diagnosed with unilateral breast cancer
Measured: 2014-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start18 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2021 (estimated)
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 Unilateral Breast CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de investigación C.E.R
- Sponsor type
- University, hospital or other
- Collaborators
- Hematooncologos S.A.
- Responsible party
- Principal investigator, Maria Isabel Cadena, Grupo de investigación C.E.R
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987424
- Sponsor's protocol ID
- CER2021
- Status last verified
- Aug 2021
- First submitted
- 23 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25220842
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04987424
- Acronym / sponsor ID
- CER2021
- Conditions
- Unilateral Breast Cancer
- Keywords
- Lymphedema, breast cancer, prevalence, risk factors, epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Grupo de investigación C.E.RUniversity, hospital or other
- Collaborators
- Hematooncologos S.A.
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Aug 2021 (actual)
- 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.
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
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between 2008 and 2020 a sample of 367 patients with a diagnosis of unilateral breast cancer was established
Key inclusion criteria (1 listed)
- Unilateral breast cancer, cancer diagnosis between 2008-2020 in the oncology institution Colombia
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Development and validation of Lymphedema levels diagnosticA 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 . | Diagnostic test | – |
Primary outcome
Prevalence of lymphedema
Time frame: 2014-2020
Determining the prevalence of lymphedema in patients diagnosed with unilateral breast cancer
1 secondary outcome
Risk Factors
Time frame: 2014-2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Background: PubMed 25220842Ferlay 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.
- Hematooncologos web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unilateral Breast Cancer, run by Grupo de investigación C.E.R at 1 site in Colombia.
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: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Prevalence of lymphedema (time frame: 2014-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04987424, 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 9 Aug 2021.