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Breast Cancer and Chemo-amennorhea (chemo-ameno)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01867229
Recruitment Status : Completed
First Posted : June 3, 2013
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Tracking Information
First Submitted Date May 29, 2013
First Posted Date June 3, 2013
Last Update Posted Date April 10, 2019
Study Start Date October 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 31, 2013)
incidence and duration of the amenorrhea induced by chemotherapy [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Breast Cancer and Chemo-amennorhea
Official Title Etude Prospective Multicentrique de l'aménorrhée Chimio-induite et de sa réversibilité Dans le Cancer du Sein Chez Des Patientes préménopausées Recevant Une chimiothérapie Adjuvante ou néoadjuvante. Etude Améno-Chimio.
Brief Summary Relation between chemotherapy and amennorhea
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population pre-menauposal breast cancer treated with chemotherapy
Condition Breast Cancer
Intervention Other: observational
standard of care fore patients with non metastatic breast cancer
Study Groups/Cohorts FEC- TC
Fluorouracil- Epiadriamycine- Cyclophosphamide Taxotère-Cyclophosphamide
Intervention: Other: observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 8, 2019)
7
Original Estimated Enrollment
 (submitted: May 31, 2013)
500
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

metastases menopausal

-

Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01867229
Other Study ID Numbers UCL-gyneco-001
2009/07DEC/377 ( Other Identifier: CEHF )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators Not Provided
Investigators
Principal Investigator: jean-Pascal Machiels UCL-Saint Luc
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date April 2019