Registry of Local Recurrences After Breast-conserving Sur... | NCT05406661

Studies
Registry of Local Recurrences After Breast-conserving Surgery

NCT05406661

Sponsor

Universidade do Porto

Status

Not yet recruiting

Last Update Posted

Oct 19, 2023Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Breast Cancer Recurrent

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Jun 1, 2022

First Submission Date that Met QC Criteria

Jun 1, 2022

First Posted Date

Jun 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2023

Last Update Posted Date

Oct 19, 2023Actual

Name	Class
Centro Hospitalar De São João, E.P.E.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Identification of risk factors for local recurrence	Frequency of risk factors	On inclusion time (2 years)
Identification of predictive and response factors	Frequency of predictive factors

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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
1. and adjuvant breast RT: total (WBI) or partial (PBI)
2. 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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female patients

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with local recurrence after breast-conserving surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

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

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided