UNDERSTANDING the RAREST GYNECOLOGICAL CANCERS: a MULTI -OMICS PLATFORM for IMPROVED PATIENTS MANAGEMENT (ROAR)

Rare gynecological cancers including uterine sarcomas, vulvar and non-epithelial ovarian cancers, are under-studied diseases and the absence of standardized diagnostic and therapeutic approaches or tailored clinical guidelines led to low survival rates and/or poor quality of life outcomes.

The ROAR project aims at increasing the molecular understanding of these diseases in a multidisciplinary, interinstitutional setting including gynecologic oncologists, medical oncologists, phase I researchers, pathologists, molecular pathologist, research nurses, genetists, bioinformatics, psychologists and patients' advocacy groups.

The project will pursue this aim through the following activities:

1. Harmonizing procedures and enabling safe and easy data sharing across all involved institutions; this will be achieved by reviewing the available clinical and molecular data (WP1), establishing an interinstitutional second-opinion board (WP2/Task1), developing a dedicated electronic customized research form (WP2/Task2) and deploying a genomics platform (WP2/Task3).
2. Performing comprehensive somatic and transcriptional profiling as well as immunological landscape assessments on high quality annotated samples stored in a biobank dedicated to rare gynecological cancers; this will require systematic and standardized clinical data and biological samples collection (WP3/WP4), standardization of pre-analytical and sequencing procedures (WP5/6). The board will tailor indications and modalities for genomics and liquid biopsy assessments based on clinical features.
3. Evaluating the clinical impact of the board on rare gynecological cancers management and, through the evidence gathered, implementing diagnostic and therapeutic strategies; this will include analyzing the activities of the board (WP7/Task 1.1), integrating -omics data in the board report (WP7/Task 1.2), evaluating liquid biopsy role in identifying minimal residual disease post-surgery, disease monitoring over time, capability of capturing tumor heterogeneity at baseline and identifying hot spot actionable molecular alterations. Finally, the evidence gathered from the ROAR project, will allow update of clinical guidelines or provide new recommendations for each rare gynecological cancer included. The results of ROAR will also be disseminated through direct access to the integrated platform developed.

Study Overview

• Status: Not yet recruiting
• Conditions: Uterine Sarcoma; Vulvar Cancer; Non Epithelial Ovarian Cancers (NEOC)

• Study Type: Observational
• Enrollment (Estimated): 190

Contacts and Locations

• Study Contact: Name: Giovanni Scambia; Phone Number: 0630151; Email: giovanni.scambia@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

30 patients with non-epithelial ovarian tumors, 40 with uterine sarcomas, and 120 with vulvar tumors

Description

Inclusion Criteria:

• >18 years old

Histological diagnosis of:

Non-epithelial ovarian tumors Uterine sarcomas Vulvar cancer

Exclusion Criteria:

• Active HIV, HBV, or HCV infection Synchronous neoplasms Non-rare histologies of gynecological malignancies

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To revise available data on RGCs, implement standards of care procedures for RGCs across all involved centers and establish the infrastructure to run the project.	6 months
Integration and implementation of high quality annotated samples storage, clinical data collection and multi-omics molecular data generation in a data-biobank dedicated to RGCs.	12 months
Impact of molecular data on clinical management of rare gynecological cancers patients.	12 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Vulvar Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vulvar Neoplasms
• Other Study ID Numbers: ID 6868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No