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Not yet recruiting NCT05406661

Registry of Local Recurrences After Breast-conserving Surgery

Observational Breast Cancer Recurrent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Cancer Recurrent. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Registry of Local Recurrences After Breast-conserving Surgery in Portugal and Spain

Overview

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.

Primary outcome measures

  • Determine prevalence of local recorrence of breast cancer after conserving surgery in Portugal and Spain [Time frame: 2 years]
  • Follow-up of recurrences up to 5 years after treatment of first recurrence [Time frame: 5 years]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05406661 · R_ReLoCC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗