- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02745262
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)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Breast cancer is a disease where the tumor size, lymph node involvement and histological grade provide rich information about prognosis and enable to stage the disease. As in any other oncological pathology, stage of disease at diagnosis is the major determining factor for estimating survival. Ovarian stimulation for fertility preservation is performed in this study, in patients with stage I-II (TNM) after the neoplasia is treated (surgical removal of the tumor) prior to systemic therapy, when indicated.
Among young women there is a greater incidence of basal type tumors and HER2 (human epidermal growth factor receptor 2), which do not always express hormone receptors. In early stages of the disease, the controlled ovarian stimulation procedure, after removal of the tumor, has not revealed any worsening in the prognosis of the disease, in terms of overall survival and disease-free survival (absence of local or distant recurrence).
It is a study that aims to collect data retrospectively from 2008 to 31 December 2015. To this end, we will collect the follow-up data, up to 5 years for patients from 2008, 2009 and 2010. Four years for patients in 2011, 3 years for 2012, 2 years for 2013, one year for those included until 31 December 2014 and patients followed until 31 December 2015. Each patient is called in order to request data authorization, to complete and track information.
Type d'étude
Inscription (Réel)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Age under 40 years ( at the time of diagnosis)
- TNM stage I- II
- Authorization of the fertility preservation multidisciplinary committee
Exclusion Criteria:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Controlled ovarian stimulation
No drugs are administered.
It is an observational study.
Collect retrospectively the follow-up data
|
Collect retrospectively the follow-up data.
Each patient is called in order to request data authorization, to complete and track information.
|
|
Non Controlled ovarian stimulation
No drugs are administered.
It is an observational study.
Collect retrospectively the follow-up data
|
Collect retrospectively the follow-up data.
Each patient is called in order to request data authorization, to complete and track information.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Overall survival rate
Délai: Up to 60 months
|
Up to 60 months
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
- Oktay 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.
- Frydman 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1405-VIG-030-EM
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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