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

March 19, 2021 updated by: Paolo Zola, Azienda Ospedaliera San Giovanni Battista

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20089
      • Turin, Italy, 10100
        • Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
        • Contact:
        • Principal Investigator:
          • Giovannino Ciccone, PhD/MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The study population will be composed of about 190 women with a diagnosis of EOC, identified through the ovarian cancer audit conducted by the "Rete Oncologica Piemonte e Valle d'Aosta" between 2015 and 2020. In order to be eligible for the study, patients should respect the following inclusion criteria:

  • age ≥18 years;
  • confirmed histologic diagnosis of HGS-EOC or high grade endometroid 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;

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate that clonal pathogenic TP53 variants of HGS-EOC can be detected in patient-matched PAP tests
Time Frame: 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.
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.
Demonstrate that clonal pathogenic TP53 variants of HGS-EOC can be detected in patient-matched PAP tests
Time Frame: In the following six months the data obtained are processed. The final analisys is forecast within one year.
The second outcome is the evaluation of the percentage of pap test negative for cervical cancer and positive for genetic determination of ovarian neoplastic cells in pre clinic stage of ovarian neoplasia.
In the following six months the data obtained are processed. The final analisys is forecast within one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera San Giovanni Battista

Collaborators

Humanitas Hospital, Italy

Investigators

  • Principal Investigator: Paolo Zola, MD/PhD, Department of Surgical Science University of Turin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 12, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAPAudit

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study is part of a more complex and long-lasting project aimed to develop an innovative strategy for early diagnosis of EOC. It aims to detect TP53 variants in the DNA purified from PAP tests, as an early genetic biomarker of EOC tumorigenesis.

IPD Sharing Time Frame

12-18 months

IPD Sharing Access 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;
  • written informed consent for the participation to the study and the molecular analysis of biological samples.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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