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

NCT06582108 | Not Yet Recruiting

• 1 other identifier: ID 6868
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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.

Conditions

Uterine Sarcoma; Vulvar Cancer; Non Epithelial Ovarian Cancers (NEOC)

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

DNA, RNA, ctDNA, metabolomics GENETIC

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \>18 years old
• Histological diagnosis of:
• Non-epithelial ovarian tumors Uterine sarcomas Vulvar cancer

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Rome, Italy

Location

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

DNA; RNA; Circulating Tumor DNA

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; Cell-Free Nucleic Acids; DNA, Neoplasm

Central Study Contacts

Giovanni Scambia

CONTACT

0630151; giovanni.scambia@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 3, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)