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NCT Number: NCT05406661

Registry of Local Recurrences After Breast-conserving Surgery

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.

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Key information

Conditions

Breast Cancer Recurrent

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 5 years

    Number of cases per year

Secondary outcomes

  1. Identification of risk factors for local recurrence

    Time frame: On inclusion time (2 years)

    Frequency of risk factors

  2. Identification of predictive and response factors

    Time frame: On inclusion time (2 years)

    Frequency of predictive factors

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Gonçalves, MD, PhDc

CONTACT

[email protected]

(+351) 913017481

Janete Santos, PhD

CONTACT

[email protected]

(+351) 225 513 600

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

  • Centro Hospitalar De São João, E.P.E.

Registry information

Official study title

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

Acronym: R_ReLoCC

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jun 6, 2022
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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