Registry of Local Recurrences After Breast-conserving Surgery

Not yet recruiting

• Conditions: Breast Cancer Recurrent

• Registration Number: NCT05406661
• Lead Sponsor: Universidade do Porto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Study Start: 2023-12-01
• Primary Completion: 2024-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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