Registry of Local Recurrences After Breast-conserving Surgery

NCT05406661 | Not Yet Recruiting

• 1 other identifier: R_ReLoCC
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer Recurrent

Keywords

Breast cancer treatment; Local recurrences; Breast-conserving surgery

Outcome Measures

Primary Outcomes (2)

• Determine prevalence of local recorrence of breast cancer after conserving surgery in Portugal and Spain

  Number of cases per year

  2 years

• Follow-up of recurrences up to 5 years after treatment of first recurrence

  Number of cases per year

  5 years

Secondary Outcomes (4)

• Identification of risk factors for local recurrence

  On inclusion time (2 years)

• Identification of predictive and response factors

  On inclusion time (2 years)

• Determination of surgical morbidity of relapse treatment in follow up

  From date of treatment until 30 days after treatment

• Assessment of patient quality of life

  First and second year after treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female patients
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with local recurrence after breast-conserving surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Porto: lead
• Centro Hospitalar Universitário São João, EPE: collaborator

Study Officials

• José Luis Fougo, MD, PhD

  Centro de Mama - Centro Hospitalar Universitário de São João

  STUDY DIRECTOR

Central Study Contacts

Diana Gonçalves, MD, PhDc

CONTACT

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

Janete Santos, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share