NCT03669952

Brief Summary

A prospective observational longitudinal study of 464 patients was performed between 2010 and 2015. Patients with invasive ductal carcinoma (IDC) and ductal carcinoma in situ associated to invasive ductal carcinoma (DCIS +IDC) were included and analyzed.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
464

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

6 years

First QC Date

September 11, 2018

Last Update Submit

September 13, 2018

Conditions

Outcome of Breast Cancer

Keywords

Breast cancerDuctal carcinoma in situInvasive ductal carcinomaPrognosis factors

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Neoplasm metastasis, either local or distant recurrence of the invasive ductal carcinoma

    Patients included between 2010 and 2015 will be follow up til January of 2018 with a mean follow up of 51.43 months

Study Arms (1)

Invasive ductal carcinoma

Patients with Invasive ductal carcinoma

Other: None intervention

Interventions

None interventionOTHER

No interventions are realized, only observational study

Invasive ductal carcinoma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population included in the study was 464 patients. IDC was present in 221 patients (47.6%) and IDC + DCIS was present in 243 patients (52.4%).

You may qualify if:

  • Patients with invasive ductal carcinoma of the breast
  • Patients who received surgery for primary invasive breast cancer between 2010 and 2015

You may not qualify if:

  • Patients with metastasis at the diagnostic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
7 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialists in General Surgery

Study Record Dates

First Submitted

September 11, 2018

First Posted

September 13, 2018

Study Start

January 1, 2010

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

September 17, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share