Overall Survival and Disease-free Survival in Breast Cancer Patients Under COS
Retrospective Cohort Study of Overall Survival and Disease-free Survival in Breast Cancer Patients Who Underwent Controlled Ovarian Stimulation (COS)
1 other identifier
observational
400
0 countries
N/A
Brief Summary
The main objective of the study is to evaluate the overall survival and disease-free survival in breast cancer patients under 40 years old. They underwent controlled ovarian stimulation (COS) for fertility preservation versus women of the same age, type and stage of breast cancer, who have not been subjected to COS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 13, 2016
CompletedFirst Posted
Study publicly available on registry
April 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedApril 20, 2016
April 1, 2016
1 year
April 13, 2016
April 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival rate
Up to 60 months
Study Arms (2)
Controlled ovarian stimulation
No drugs are administered. It is an observational study. Collect retrospectively the follow-up data
Non Controlled ovarian stimulation
No drugs are administered. It is an observational study. Collect retrospectively the follow-up data
Interventions
Collect retrospectively the follow-up data. Each patient is called in order to request data authorization, to complete and track information.
Eligibility Criteria
Age under 40 years ( at the time of diagnosis) TNM stage I- II Authorization of the fertility preservation multidisciplinary committee
You may qualify if:
- Age under 40 years ( at the time of diagnosis)
- TNM stage I- II
- Authorization of the fertility preservation multidisciplinary committee
You may not qualify if:
- Contraindications for pregnancy
- previous history of infertility
- Previous history of ovarian surgery
- Prior chemotherapy
- History of pelvic radiation
- Diabetes Mellitus
- Hypertension
- renal failure
- liver failure
- autoimmune disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IVI Vigolead
Related Publications (3)
Cobo A, Garcia-Velasco JA, Domingo J, Remohi J, Pellicer A. Is vitrification of oocytes useful for fertility preservation for age-related fertility decline and in cancer patients? Fertil Steril. 2013 May;99(6):1485-95. doi: 10.1016/j.fertnstert.2013.02.050. Epub 2013 Mar 29.
PMID: 23541405RESULTOktay K, Rodriguez-Wallberg K, Munster P. Ovarian protection during adjuvant chemotherapy. N Engl J Med. 2015 Jun 4;372(23):2268-9. doi: 10.1056/NEJMc1504241. No abstract available.
PMID: 26039611RESULTFrydman R, Grynberg M. Introduction: Female fertility preservation: innovations and questions. Fertil Steril. 2016 Jan;105(1):4-5. doi: 10.1016/j.fertnstert.2015.10.035. Epub 2015 Nov 21.
PMID: 26612064RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elkin Muñoz
IVI Vigo
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2016
First Posted
April 20, 2016
Study Start
March 1, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2018
Last Updated
April 20, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share