Registry of Local Recurrences After Breast-conserving Surgery (R_ReLoCC)

October 18, 2023 updated by: Universidade do Porto

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with local recurrence after breast-conserving surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Collaborators

Centro Hospitalar Universitário São João, EPE
Faculty of Medicine (FMUP)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R_ReLoCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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