NCT02926547

Brief Summary

  1. 1.Identify the tissue proteins associated with early breast cancer invasion phases without lymph node involvement .
  2. 2.Consider their role in the invasion and the risk of tumor spread .

Trial Health

100
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

4.8 years

First QC Date

September 9, 2016

Last Update Submit

September 17, 2019

Conditions

Breast Cancer

Keywords

proteomics

Outcome Measures

Primary Outcomes (1)

  • A list of the ten proteins most associated with early breast cancer invasion phases without lymph node involvement .

    The primary objective of this study is to Identify the tissue proteins associated with early breast cancer invasion phases without lymph node involvement. The outcome is a list of identified proteins.

    Day 0

Study Arms (2)

CCIS

invasive breast cancer

Eligibility Criteria

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

CCIS and invasive breats cancer in women

You may qualify if:

  • Breast cancer
  • CCIS
  • Invasive tumors
  • Breast cancer tissues available in the biobank

You may not qualify if:

  • non availability of cancer tissue specimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

This proteomic study is performed on biological samples originally as part of a diagnostic approach reclassified in the absence of opposition from patients, from the Biobank of Nîmes University hospital (Ministry of Higher Education and Research No. AC-2008-107; South Mediterranean CPP III No. COL2008.04.02). For validation part, the investigators will work on sections of TMA already made from samples drawn between 2000 and 2003.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

October 6, 2016

Study Start

March 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 18, 2019

Record last verified: 2019-09