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Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET

NCT02261389 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1507

Last updated 2022-12-29

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Arm B, tumor markers assessment

Tumor markers assessment every three months through the study or until disease recurrence

Sponsors & Collaborators

  • PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany

    collaborator UNKNOWN

  • Azienda ULSS 12 Veneziana

    collaborator OTHER

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    collaborator OTHER

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Claudio Zamagni, MD · Azienda Ospedaliero-Universitaria di Bologna

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2026-11-30
Completion
2030-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02261389 on ClinicalTrials.gov