Breast Cancer RecurrentR_ReLoCCNCT05406661
Registry of Local Recurrences After Breast-conserving Surgery
An observational study of Breast Cancer Recurrent, run by Universidade do Porto.
Trial summary
The ReLoCC project is a prospective, multicenter, clinical study to register cases of local recurrence after breast-conserving surgery, in centers dedicated to the treatment of breast cancer, in Portugal and Spain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Recurrent
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Adult, Older adult
Study population: Patients with local recurrence after breast-conserving surgery
Who may be able to join
- Female patients
- Age > 18 years
- Patients who have previously undergone breast-conserving surgery as part of the treatment of invasive or non-invasive (in situ) breast cancer
- and adjuvant breast RT: total (WBI) or partial (PBI)
- without adjuvant radiotherapy to the breast
- Recent histological diagnosis of homolateral, invasive or non-invasive (in situ) breast carcinoma
Who cannot join
- Male
- Age < 18 years
- Stage 4 at diagnosis
- Patients operated outside the participating Centers and for whom it is not possible to obtain complete information regarding the primary treatment
- History of other primary invasive malignant tumor (except non-melanoma skin carcinomas)
- Patients already treated for another local recurrence of breast carcinoma
- Absence of clinical follow-up and records in clinical process
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Registry of Local Recurrences After Breast-conserving Surgery in Portugal and Spain
The ReLoCC project is a prospective, multicenter, clinical study to register cases of local recurrence after breast-conserving surgery, in centers dedicated to the treatment of breast cancer, in Portugal and Spain.
The comparison of the results obtained will allow the optimization of the treatment, making it increasingly personalized.
- Conditions
- Breast Cancer Recurrent
- Keywords
- Breast cancer treatment, Local recurrences, Breast-conserving surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine prevalence of local recorrence of breast cancer after conserving surgery in Portugal and Spain
Number of cases per year
Measured: 2 years
Follow-up of recurrences up to 5 years after treatment of first recurrence
Number of cases per year
Measured: 5 years
Secondary outcomes (4)
Identification of risk factors for local recurrence
Frequency of risk factors
Measured: On inclusion time (2 years)
Identification of predictive and response factors
Frequency of predictive factors
Measured: On inclusion time (2 years)
Determination of surgical morbidity of relapse treatment in follow up
Identification of surgical morbidity
Measured: From date of treatment until 30 days after treatment
Assessment of patient quality of life
Validated questionnaire for quality of life by EORTC QLQ-C30-BR23
Measured: First and second year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Dec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer RecurrentStudies 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
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E.
- Responsible party
- Sponsor
- Investigators
- José Luis Fougo, MD, PhD, Study director, Centro de Mama - Centro Hospitalar Universitário de São João
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406661
- Sponsor's protocol ID
- R_ReLoCC
- Acronym
- R_ReLoCC
- Status last verified
- Oct 2023
- First submitted
- 1 Jun 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Local Recurrences After Breast-conserving Surgery in Portugal and Spain
- ClinicalTrials.gov ID
- NCT05406661
- Acronym / sponsor ID
- R_ReLoCC / R_ReLoCC
- Conditions
- Breast Cancer Recurrent
- Keywords
- Breast cancer treatment, Local recurrences, Breast-conserving surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E.
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jun 2022 (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.
The ReLoCC project is a prospective, multicenter, clinical study to register cases of local recurrence after breast-conserving surgery, in centers dedicated to the treatment of breast cancer, in Portugal and Spain.
The comparison of the results obtained will allow the optimization of the treatment, making it increasingly personalized.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with local recurrence after breast-conserving surgery
Key inclusion criteria (6 listed)
- Female patients
- Age > 18 years
- Patients who have previously undergone breast-conserving surgery as part of the treatment of invasive or non-invasive (in situ) breast cancer
- Recent histological diagnosis of homolateral, invasive or non-invasive (in situ) breast carcinoma
Key exclusion criteria (7 listed)
- Male
- Age < 18 years
- Stage 4 at diagnosis
- Patients operated outside the participating Centers and for whom it is not possible to obtain complete information regarding the primary treatment
- History of other primary invasive malignant tumor (except non-melanoma skin carcinomas)
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
Determine prevalence of local recorrence of breast cancer after conserving surgery in Portugal and Spain
Time frame: 2 years
Number of cases per year
Follow-up of recurrences up to 5 years after treatment of first recurrence
Time frame: 5 years
Number of cases per year
4 secondary outcomes
Identification of risk factors for local recurrence
Time frame: On inclusion time (2 years)
Identification of predictive and response factors
Time frame: On inclusion time (2 years)
Determination of surgical morbidity of relapse treatment in follow up
Time frame: From date of treatment until 30 days after treatment
Assessment of patient quality of life
Time frame: First and second year after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- 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.
José Luis Fougo, MD, PhD study director
Centro de Mama - Centro Hospitalar Universitário de São João
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Recurrent, run by Universidade do Porto.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 19 Oct 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Gonçalves, MD, PhDc ((+351) 913017481, diana.goncalves@chsj.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine prevalence of local recorrence of breast cancer after conserving surgery in Portugal and Spain (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2023.