Registry of Local Recurrences After Breast-conserving Surgery

Breast Cancer Recurrent Clinical Trial

— R_ReLoCC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05406661
• Other study ID #: R_ReLoCC
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Universidade do Porto
• Contact: Diana Gonçalves, MD, PhDc
• Phone: (+351) 913017481
• Email: diana.goncalves[@]chsj.min-saude.pt
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Recurrent
• Recurrence

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Universidade do Porto	Centro Hospitalar Universitário São João, EPE, Faculty of Medicine (FMUP)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine prevalence of local recorrence of breast cancer after conserving surgery in Portugal and Spain	Number of cases per year	2 years
Primary	Follow-up of recurrences up to 5 years after treatment of first recurrence	Number of cases per year	5 years
Secondary	Identification of risk factors for local recurrence	Frequency of risk factors	On inclusion time (2 years)
Secondary	Identification of predictive and response factors	Frequency of predictive factors	On inclusion time (2 years)
Secondary	Determination of surgical morbidity of relapse treatment in follow up	Identification of surgical morbidity	From date of treatment until 30 days after treatment
Secondary	Assessment of patient quality of life	Validated questionnaire for quality of life by EORTC QLQ-C30-BR23	First and second year after treatment