NCT01867229

Brief Summary

Relation between chemotherapy and amennorhea

Trial Health

90
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
2 countries

6 active sites

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

October 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

2.2 years

First QC Date

May 29, 2013

Last Update Submit

April 8, 2019

Conditions

Breast Cancer

Keywords

pre-menauposalneo-adjuvant or adjuvant chemotherapyno metastases

Outcome Measures

Primary Outcomes (1)

  • incidence and duration of the amenorrhea induced by chemotherapy

    5 years

Study Arms (1)

FEC- TC

Fluorouracil- Epiadriamycine- Cyclophosphamide Taxotère-Cyclophosphamide

Other: observational

Interventions

observationalOTHER

standard of care fore patients with non metastatic breast cancer

FEC- TC

Eligibility Criteria

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

pre-menauposal breast cancer treated with chemotherapy

You may qualify if:

  • pre-menauposal breast cancer needed to be treat with chemotherapy -

You may not qualify if:

  • metastases menopausal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Clinique Saint Vincent

Rocourt, Liège, 4000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Centre Hospitalier Université de Liège

Liège, 4000, Belgium

Location

CHR Citadelle

Liège, 4000, Belgium

Location

Centre hospitalier Peltzer La Tourelle

Verviers, 4800, Belgium

Location

Institut Claudius Renaud

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • jean-Pascal Machiels

    UCL-Saint Luc

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 3, 2013

Study Start

October 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations

BE(5)FR(1)