R_ReLoCC: Registry of Local Recurrences After Breast-conserving Surgery

Sponsor

Universidade do Porto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05406661

Collaborator

Centro Hospitalar De São João, E.P.E. (Other)

3,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Recurrent

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2026

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universidade do Porto
Centro Hospitalar De São João, E.P.E.

Investigators

Study Director: José Luis Fougo, MD, PhD, Centro de Mama - Centro Hospitalar Universitário de São João

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universidade do Porto

ClinicalTrials.gov Identifier:

NCT05406661

Other Study ID Numbers:

R_ReLoCC

First Posted:

Jun 6, 2022

Last Update Posted:

Jun 6, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Universidade do Porto

Breast cancer treatment

Local recurrences

Breast-conserving surgery

Additional relevant MeSH terms:

Recurrence

Study Results

No Results Posted as of Jun 6, 2022