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Trial Title:
Endometrial Changes in Breast Cancer Women.
NCT ID:
NCT05717634
Condition:
Endometrial Cancer
Endometrial Hyperplasia With Atypia
Breast Cancer
TAM
Conditions: Official terms:
Breast Neoplasms
Endometrial Neoplasms
Endometrial Hyperplasia
Hyperplasia
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Hysteroscopy
Description:
Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial
biopsy or endometrial lesion excision.
Arm group label:
Ais
Arm group label:
No Therapy
Arm group label:
TAM
Other name:
Endometrial biopsy
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.
Criteria for eligibility:
Study pop:
Breast cancer patients, divided in three groups: tamoxifen users, aromatase inhibitors
users and no therapies.
Sampling method:
Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
IRCCS "Regina Elena" National Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Start date:
January 26, 2023
Completion date:
January 26, 2024
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Collaborator:
Agency:
University of Palermo
Agency class:
Other
Collaborator:
Agency:
University of Padova
Agency class:
Other
Collaborator:
Agency:
Universita di Verona
Agency class:
Other
Collaborator:
Agency:
Federico II University
Agency class:
Other
Collaborator:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Collaborator:
Agency:
University of Messina
Agency class:
Other
Collaborator:
Agency:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05717634
