Clinical trial · Observational
Exploiting Pathogenic Tp53 Mutation for Early Diagnosis of Ovarian Cancer by Mean of Papanicolau Test
NCT04812938CI-TRIAL-00050857PAPAuditunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patients with Ovarian cancer and pap test available | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Demonstrate that clonal pathogenic TP53 variants of HGS-EOC can be detected in patient-matched PAP tests
- timeFrame
- 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.
- description
- 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.
- measure
- Demonstrate that clonal pathogenic TP53 variants of HGS-EOC can be detected in patient-matched PAP tests
- timeFrame
- In the following six months the data obtained are processed. The final analisys is forecast within one year.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
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
References
Publications (18)
- RESULTBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
- RESULTReid BM, Permuth JB, Sellers TA. Epidemiology of ovarian cancer: a review. Cancer Biol Med. 2017 Feb;14(1):9-32. doi: 10.20892/j.issn.2095-3941.2016.0084. PMID 28443200
- RESULTBast RC Jr, Matulonis UA, Sood AK, Ahmed AA, Amobi AE, Balkwill FR, Wielgos-Bonvallet M, Bowtell DDL, Brenton JD, Brugge JS, Coleman RL, Draetta GF, Doberstein K, Drapkin RI, Eckert MA, Edwards RP, Elias KM, Ennis D, Futreal A, Gershenson DM, Greenberg RA, Huntsman DG, Ji JXY, Kohn EC, Iavarone C, Lengyel ER, Levine DA, Lord CJ, Lu Z, Mills GB, Modugno F, Nelson BH, Odunsi K, Pilsworth JA, Rottapel RK, Powell DJ Jr, Shen L, Shih IM, Spriggs DR, Walton J, Zhang K, Zhang R, Zou L. Critical questions in ovarian cancer research and treatment: Report of an American Association for Cancer Research Special Conference. Cancer. 2019 Jun 15;125(12):1963-1972. doi: 10.1002/cncr.32004. Epub 2019 Mar 5. PMID 30835824
- RESULTHenderson JT, Webber EM, Sawaya GF. Screening for Ovarian Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2018 Feb 13;319(6):595-606. doi: 10.1001/jama.2017.21421. PMID 29450530
- RESULTMenon U, Gentry-Maharaj A, Hallett R, Ryan A, Burnell M, Sharma A, Lewis S, Davies S, Philpott S, Lopes A, Godfrey K, Oram D, Herod J, Williamson K, Seif MW, Scott I, Mould T, Woolas R, Murdoch J, Dobbs S, Amso NN, Leeson S, Cruickshank D, McGuire A, Campbell S, Fallowfield L, Singh N, Dawnay A, Skates SJ, Parmar M, Jacobs I. Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Lancet Oncol. 2009 Apr;10(4):327-40. doi: 10.1016/S1470-2045(09)70026-9. Epub 2009 Mar 11.