Breast Cancer, Endometrial Cancer, Endometrial Hyperplasia With Atypia, TAM
Conditions
Brief summary
This is a prospective observational multicentric study. The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.
Detailed description
This is a prospective observational multicentric study. Patient with a history of breast cancer treated with adjuvant hormonal therapies or with no therapies, will be enrolled and followed once a year with physical exam and endovaginal ultrasound. Patients with suspected endometrial pathology will undergo hysteroscopy with endometrial biopsy or endometrial lesion resection. The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.
Interventions
DIAGNOSTIC_TESTHysteroscopy
Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.
Sponsors
University of Palermo
University of Padova
Universita di Verona
Federico II University
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
University of Messina
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Regina Elena Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Personal history of breast cancer
Exclusion criteria
* Personal history of other hormonal sensitive cancers * Assumption of hormones in the previous 5 years * Previous medical assisted reproduction technique * Lynch syndrome or BRCA 1/2 mutations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of endometrial cancer | One year | Evaluation of the incidence of endometrial cancer and atypical hyperplasya |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasonographic soft markers of endometrial pathology | One year | Identification of ultrasonographic soft markers of endometrial pathology |
Countries
Italy
Outcome results
None listed