Ovarian Cancer
Conditions
Keywords
Ovarian cancer, pap-test
Brief summary
The aim of the project is to corroborate them on a large retrospective cohort of HGS-EOC and confirm the possibility of identify TP53 mutations in high grade endometrioid tumors. This will consequently allow to confirm the previous results and define with a greater precision the temporal windows in which it will be possible to detect, through the TP53 analysis, tumor material by vaginal swab sampling. The results of the study will be the first step of a multiphase prospective validation program for the development of a novel approach for early diagnosis of EOC.
Detailed description
All participating women will be identified through the ovarian cancer audit implemented by the Oncological Network of Piedmont and Valle d'Aosta and the Clinical Epidemiology Unit of CPO Piemonte between 2015 and 2020. Women with EOC, and the center where they have been treated for the tumor, will be identified by linking the databases of the Oncological Network of Piedmont and Valle d'Aosta with those of the Prevenzione Serena project. A few clinical information from EOC patients will be collected by clinical investigators at each center using an electronic case report form (e-CRF) developed at the Mario Negri Institute. These information will include age, date of diagnosis, histological subtype and grading, tumor stage according to FIGO 2014 classification2,3, previous gynecologic conditions and surgical operations, date of Pap Test collection, and Pap Test cytological reports. Participants' data will be identified by a unique patient code.
Interventions
DIAGNOSTIC_TESTPatients with Ovarian cancer and pap test available
Define the possibility to detect through the pap test the presence of ovarian cancer cells in vaginal smear in patients with no evidence of ginecological malignancies.
Sponsors
Humanitas Hospital, Italy
Azienda Ospedaliera San Giovanni Battista
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
age ≥18 years; * confirmed histologic diagnosis of HGS-EOC or high grade endometrioid tumor; * presence of one FFPE primary tumor biopsy with at least 40% of tumor cells based on Hematoxylin and Eosin staining, in the archive of the Pathology Departments of the hospital centers where they have been treated; * presence of one or more Pap Tests sampled up to eight years before EOC diagnosis during routine cervical cancer screening; * negative history for other gynecologic malignancies;
Exclusion criteria
* pap test not available in patients with ovarian cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate that clonal pathogenic TP53 variants of HGS-EOC can be detected in patient-matched PAP tests | We can estimate six month to obtain pathological sample from the different hospital involved in this protocol and in the mean time to set up the laboratory procedures in large scale. | To validate the preliminary data obtained by Paracchini 14, which found that the clonal pathogenic TP53 variants of HGS-EOC can be detected in PAP tests of patient tratted by ovarian cancer performed more than two years before the diagnosis of ovarian neoplasia. Within this aim, we will calculate the detection rate and define the temporal window up to which the detection of the TP53 variant is feasible and set up the optimal experimental conditions, such as DNA quality and quantity, that will be used in the downstream steps for the assay development. |
Countries
Italy
Contacts
Primary ContactMaria Elena Laudani, MD
Backup ContactMaurizio D'Incalci, MD/PhD
Outcome results
None listed