Spots Global Cancer Trial Database for Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET
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Trial Identification
Brief Title: Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET
Official Title: Three-monthly Dynamic Evaluation of CEA and CA 15.3 vs Usual Practice in the Follow-up of Early Breast Cancer Patients: a Randomized Study
Study ID: NCT02261389
Conditions
Interventions
Study Description
Brief Summary: The main purpose of follow-up in asymptomatic breast cancer patients during and after adjuvant treatment is to detect breast cancer recurrence and metastatic disease.The aim of this trial is to verify if, in asymptomatic patients, the serial measurement of serum CEA and CA 15.3, with diagnostic imaging procedures (18FDG-PET) performed only in case of a critical increase of serum CEA and CA 15.3 level, can anticipate the diagnosis of breast cancer local and distant recurrence compared to the usual follow-up practice.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Azienda Sanitaria dell'Alto Adige - Ospedale di Bressanone, Bressanone, Bolzano, Italy
Azienda Sanitaria dell'Alto Adige - Ospedale di Merano, Merano, Bolzano, Italy
ASL13 - Presidio Ospedaliero Mirano, U.O.C. Oncologia ed Ematologia Oncologica, Mirano, Venezia, Italy
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii, Bologna, , Italy
Azienda Sanitaria dell'Alto Adige - Ospedale Centrale di Bolzano, Bolzano, , Italy
Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, , Italy
IRCCS Azienda Ospedaliera S. Maria Nuova di Reggio Emilia, Reggio Emilia, , Italy
Contact Details
Name: Claudio Zamagni, MD
Affiliation: Azienda Ospedaliero-Universitaria di Bologna
Role: PRINCIPAL_INVESTIGATOR
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