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NCT Number: NCT07556562

Early Diagnosis of High-grade Serous Epithelial Ovarian Cancer Through the Analysis of DNA Derived From Pap Test Smear.

Ovarian cancer is the leading cause of death among gynecological malignancies. No screening test is available for this tumor. Serous Tubal Intraepithelial Carcinoma (STIC) is the precursor lesion of the high grade serous ovarian cancer (HGSOC). Preliminary data suggest that tumor cells from STIC shed into the luminal space to reach the cervix and identical molecular alterations can be identified in the STIC and pap smears taken several years before the diagnosis. Early diagnosis could be achieved by detecting tumor components in cervical smears. This prospective/retrospective project plans to enroll high risk, germline mutated women submitted to risk reducing annessiectomy to compare the concordance of molecular alterations between tubal specimens and DNA from Pap test in order to validate a possible screening test with potential impact in reducing cancer mortality. Moreover, the evaluation of the influence of tumor micro environment in the progression from STIC to HGSOC will be studied.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, 00186, Italy

Location status: Recruiting

Location contact

NERO CAMILLA, MD

CONTACT

[email protected]

0630157971

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with germline mutations candidate to prophylactic surgery RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)
  • Able and willing to sign informed consent

Exclusion criteria

  • Germline mutated patients unwilling to join the trial and non-compliant with trial procedures

Treatment and study plan

RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)

Procedure

Patients with germline mutations underwent RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)

Primary outcomes

  1. NGS-Based Detection of Tubal Precancerous Lesions Using Pap Test DNA

    Time frame: 1 year

    To assess the concordance between the evidence of precancerous/cancerous tubal lesions and the results of NGS analysis in pDNA derived from Pap test smears longitudinally collected before prophylactic surgery.

    This aim would assess whether large genomic aberrations in pDNA are a predictive biomarker for the presence of STIC or tubal precancerous lesions and could be used for early detection of HGSOC.

Secondary outcomes

  1. Tumor Microenvironment in STIC-to-HGSOC Progression

    Time frame: 1 year

    To define the role of tumor microenvironment (TME) in patho-oncogenic process of the neoplastic transformations from STIC to HGSOC.

Study contacts

Contact information is provided by the study sponsor or research team.

NERO CAMILLA, MD

CONTACT

[email protected]

0630157971

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: EVATEST

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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