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

NCT04812938 | Unknown

• 1 other identifier: PAPAudit
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 2

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.

Conditions

Ovarian Cancer

Keywords

Ovarian cancer; pap-test

Outcome Measures

Primary Outcomes (2)

• Demonstrate that clonal pathogenic TP53 variants of HGS-EOC can be detected in patient-matched PAP tests

  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

  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.

Interventions

Patients with Ovarian cancer and pap test available DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 110 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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;

You may qualify if:

• 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;

You may not qualify if:

• pap test not available in patients with ovarian cancer

Sponsors & Collaborators

• Azienda Ospedaliera San Giovanni Battista: lead
• Humanitas Hospital, Italy: collaborator

Study Sites (2)

Department of Biomedical Sciences - Humanitas University

Milan, 20089, Italy

Location

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, 10100, Italy

Location

Related Publications (18)

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Biospecimen

Retention: SAMPLES WITH DNA

For each EOC patient, one FFPE biopsy from primary tumor, possibly one FFPE biopsy from a synchronous metastatic lesion will be retrieved from the Laboratory of Pathological Anatomy at each hospital center. For each FFPE sample, a minimum tumor content of 40% will be guarantee by the pathologist of the hospital who performed the diagnosis of EOC and at least three to six slides (5 micron thick) will be prepared, with the representative area of tumor marked on each slide for DNA purification. Moreover, all available patient's Pap Test smears sampled up to eight years before EOC diagnosis will be collected. All samples will be shipped to and stored at the Laboratory of Cancer Pharmacology, IRCCS Humanitas Research Hospital at under the responsibility of Dr. Sergio Marchini.

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Paolo Zola, MD/PhD

  Department of Surgical Science University of Turin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Elena Laudani, MD

CONTACT

+39 0113131523; melaudani@gmail.com

Maurizio D'Incalci, MD/PhD

CONTACT

+39 3333292141; maurizio.dincalci@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 24, 2021
• Study Start: April 12, 2021
• Primary Completion: April 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12-18 months
• 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.

Locations

IT (2)