Registry of Local Recurrences After Breast-conserving Surgery

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05406661

Acronym

R_ReLoCC

Enrollment

3000

Registered

2022-06-06

Start date

2023-12-01

Completion date

2026-12-31

Last updated

2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Recurrent

Keywords

Breast cancer treatment, Local recurrences, Breast-conserving surgery

Brief 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. The comparison of the results obtained will allow the optimization of the treatment, making it increasingly personalized.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Inclusion criteria

1. Female patients 2. Age \> 18 years 3. Patients who have previously undergone breast-conserving surgery as part of the treatment of invasive or non-invasive (in situ) breast cancer 1. and adjuvant breast RT: total (WBI) or partial (PBI) 2. without adjuvant radiotherapy to the breast 4. Recent histological diagnosis of homolateral, invasive or non-invasive (in situ) breast carcinoma

Exclusion criteria

1. Male 2. Age \< 18 years 3. Stage 4 at diagnosis 4. Patients operated outside the participating Centers and for whom it is not possible to obtain complete information regarding the primary treatment 5. History of other primary invasive malignant tumor (except non-melanoma skin carcinomas) 6. Patients already treated for another local recurrence of breast carcinoma 7. Absence of clinical follow-up and records in clinical process

Design outcomes

Primary

Measure	Time frame	Description
Determine prevalence of local recorrence of breast cancer after conserving surgery in Portugal and Spain	2 years	Number of cases per year
Follow-up of recurrences up to 5 years after treatment of first recurrence	5 years	Number of cases per year

Secondary

Measure	Time frame	Description
Identification of risk factors for local recurrence	On inclusion time (2 years)	Frequency of risk factors
Identification of predictive and response factors	On inclusion time (2 years)	Frequency of predictive factors
Determination of surgical morbidity of relapse treatment in follow up	From date of treatment until 30 days after treatment	Identification of surgical morbidity
Assessment of patient quality of life	First and second year after treatment	Validated questionnaire for quality of life by EORTC QLQ-C30-BR23

Contacts

Primary ContactDiana Gonçalves, MD, PhDc

diana.goncalves@chsj.min-saude.pt(+351) 913017481

Backup ContactJanete Santos, PhD

investigaclinica@med.up.pt(+351) 225 513 600

Outcome results