Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05146505
Other study ID # 788/2021/Sper/AOUBo
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date October 1, 2023

Study information

Verified date December 2021
Source IRCCS Azienda Ospedaliero-Universitaria di Bologna
Contact Anna Myriam Perrone, MD
Phone +39 051 2144392
Email myriam.perrone@aosp.bo.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

High grade serous ovarian cancer represents the gynecological malignancy with the highest incidence of mortality. Decision-making tools are currently limited to the use of standard imaging modalities and analysis of serum biomarkers, such as CA 125, which often have low specificity and sensitivity. Recently, a growing research interest has been aimed at so-called circulating microRNAs (miRNAs). Indeed, it has been observed that miRNAs are abundantly present in all biological fluids and play the key role of messengers in intercellular communication. Cancer cells have a rapid turnover which results in a continuous release of nucleic acids and vesicles derived from the tumor itself, such as the tumor cells themselves that separate from the tumor mass to enter the bloodstream. Given their important role as modulators of gene expression, in order to preserve their integrity, miRNAs are encapsulated in specific vesicles, in order to prevent their degradation by the enzymes present in biological fluids. In this context, the chance of monitoring the expression levels of specific miRNAs represents a very interesting option both for an early diagnosis and for monitoring the clinical response to pharmacological treatment. Currently, there are no non-invasive approaches to monitor the clinical outcome in real time, while the identification of circulating biomarkers would allow prompt intervention, possibly modifying the pharmacological management in case of progression.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - age>18 - Histological diagnosis of epithelial ovarian cancer - Patients eligible for surgery - Patients followed in the clinical care pathway c / o oncological gynecology (surgery and follow up) - informed consent Exclusion Criteria: - Patients with HCV, HBV and HIV - Patients with other malignancies diagnosed less than 5 years prior to the diagnosis of ovarian malignancy - Ovarian metastases of primary neoplasms of other organs - Presence of ascites for non-neoplastic causes

Study Design


Locations

Country Name City State
Italy IRCCS- Azienda Ospedaliera-Universitaria di Bologna Bologna Bo

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Longitudinal miRNAs analysis over chemotherapy Evaluation of miRNA expression in longitudinal blood samples collected during every follow-up 2 years
Secondary Associaition miRNA-clinico-pathological data Correlation between miRNAs deregulation and clinico-pathological and molecular data 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT06136884 - A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors Phase 1
Completed NCT01853306 - A Study to Evaluate the Safety, Pharmacokinetics and Oral Bio Availability of Veliparib in Subjects With Solid Tumors Phase 1
Terminated NCT05329545 - Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT) Phase 3
Active, not recruiting NCT01883297 - "Re-Stimulated" TILs And IL-2 Therapy for Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Phase 1
Recruiting NCT05512208 - A Phase 2 Study of Avutometinib (VS-6766) Plus Defactinib Phase 2
Recruiting NCT06084195 - Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging N/A
Recruiting NCT04261465 - NUVOLA TRIAL Open-label Multicentre Study Phase 2
No longer available NCT03123211 - Expanded Access to Veliparib