NCT03580837

Brief Summary

The aim of this retrospective study is to evaluate the value of pre-treatment and post-treatment multimodality MRI study, including quantitative evaluation of background parenchymal enhancement, for response prediction and evaluation. This study will include 100 patients treated in a single institution between 2011 and 2016

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

July 9, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

January 3, 2018

Last Update Submit

June 25, 2018

Conditions

Breast Cancer

Keywords

Breast CancerNeoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Presence or absence of of pathologic enhancement of breast by MRI

    This work concerns 110 patients treated with neoadjuvant chemotherapy for breast cancer and having received a breast MRI in pre and post-chemiotherapy at the Hautepierre Hospital.

    1 hour after the realization of the MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with breast cancer treated with neoadjuvant chemotherapy

You may qualify if:

  • Adult patients
  • Patients with breast cancer treated with neoadjuvant chemotherapy
  • Patients with pre- and post-chemotherapy MRI
  • Patients who have given their agreement to use their data for research purposes.

You may not qualify if:

  • \- Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Imagerie 1

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sébastien MOLIERE, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien MOLIERE, MD

CONTACT

33 3 88 12 78 65sebastien.moliere@chru-strasbourg.fr

Marie-Noëlle ROEDLICH, MD

CONTACT

33 3 88 12 78 65marie-noelle.roedlich@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2018

First Posted

July 9, 2018

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

July 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)