Germline MutationsEVATESTNCT07556562
Early Diagnosis of High-grade Serous Epithelial Ovarian Cancer Through the Analysis of DNA Derived From Pap Test Smear.
A study testing RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy) in people with Germline Mutations, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Germline Mutations
- What is being tested?
- RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteItaly
- Study dates
- 9 Sep 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Germline mutated patients unwilling to join the trial and non-compliant with trial procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Roma, Roma, 00186
NERO CAMILLA, MD, 0630157971, camilla.nero@policlinicogemelli.it
About this study
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.
- Conditions
- Germline Mutations
- Being tested
- RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)Procedure or surgery
Patients with germline mutations underwent RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)
| Study group | Role | What they receive |
|---|---|---|
| Risk-Reducing Salpingo-Oophorectomy or Salpingectomy in Patients with Germline Mutations | Other | Patients with germline mutations candidate to prophylactic surgery RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy) Receives: Procedure: RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
NGS-Based Detection of Tubal Precancerous Lesions Using Pap Test DNA
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.
Measured: 1 year
Secondary outcomes (1)
Tumor Microenvironment in STIC-to-HGSOC Progression
To define the role of tumor microenvironment (TME) in patho-oncogenic process of the neoplastic transformations from STIC to HGSOC.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start9 Sep 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germline MutationsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LORUSSO DOMENICA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556562
- Sponsor's protocol ID
- 6899
- Acronym
- EVATEST
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of High-grade Serous Epithelial Ovarian Cancer Through the Analysis of DNA Derived From Pap Test Smear.
- ClinicalTrials.gov ID
- NCT07556562
- Acronym / sponsor ID
- EVATEST / 6899
- Conditions
- Germline Mutations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risk-Reducing Salpingo-Oophorectomy or Salpingectomy in Patients with Germline Mutations | Other | Procedure: RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)Patients with germline mutations candidate to prophylactic surgery RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Germline mutated patients unwilling to join the trial and non-compliant with trial procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)Patients with germline mutations underwent RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy) | Procedure or surgery | Risk-Reducing Salpingo-Oophorectomy or Salpingectomy in Patients with Germline Mutations |
Primary outcome
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.
1 secondary outcome
Tumor Microenvironment in STIC-to-HGSOC Progression
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy) in people with Germline Mutations, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NERO CAMILLA, MD (0630157971, camilla.nero@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NGS-Based Detection of Tubal Precancerous Lesions Using Pap Test DNA (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.