Exploiting Pathogenic Tp53 Mutation for Early Diagnosis of Ovarian Cancer by Mean of Papanicolau Test

NCT ID: NCT04812938

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 190 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2022-10-01

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.

Conditions

Ovarian Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Patients 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Humanitas Hospital, Italy

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera San Giovanni Battista

OTHER

Sponsor Role: lead

Responsible Party

Paolo Zola

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Zola, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgical Science University of Turin

Locations

Department of Biomedical Sciences - Humanitas University

Milan, , Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, , Italy

Countries

Italy

Central Contacts

Maria Elena Laudani, MD

Role: CONTACT

melaudani@gmail.com

+39 0113131523

Maurizio D'Incalci, MD/PhD

Role: CONTACT

maurizio.dincalci@humanitas.it

+39 3333292141

Facility Contacts

Maurizio D'Incalci, PhD/MD

Role: primary

maurizio.dincalci@hunimed.eu

Paolo Zola, PhD/MD

Role: primary

paolo.zola@unito.it

+390113131523

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Other Identifiers

PAPAudit

Identifier Type: -

Identifier Source: org_study_id