UNDERSTANDING the RAREST GYNECOLOGICAL CANCERS: a MULTI -OMICS PLATFORM for IMPROVED PATIENTS MANAGEMENT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DNA, RNA, ctDNA, metabolomics.
- Who it may be relevant to
- Registry conditions: Uterine Sarcoma, Vulvar Cancer, Non Epithelial Ovarian Cancers (NEOC). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Genetic DNA, RNA, ctDNA, metabolomics
The use of specific assays or global molecular profiling to identify novel biomarkers based on DNA, RNA, protein, lipids, or metabolites obtained from tumor tissue or body fluids
Primary outcome measures
- 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. [Time frame: 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. [Time frame: 12 months]
- Impact of molecular data on clinical management of rare gynecological cancers patients. [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Gemelli IRCCS — Rome
Identifiers
NCT: NCT06582108 · ID 6868