Uterine SarcomaROARNCT06582108
UNDERSTANDING the RAREST GYNECOLOGICAL CANCERS: a MULTI -OMICS PLATFORM for IMPROVED PATIENTS MANAGEMENT
An observational study of Uterine Sarcoma and Vulvar Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Sarcoma, Vulvar Cancer, Non Epithelial Ovarian Cancers (NEOC)
- What is being tested?
- DNA, RNA, ctDNA, metabolomics
- How many people
- 190 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients with non-epithelial ovarian tumors, 40 with uterine sarcomas, and 120 with vulvar tumors
Who may be able to join
- >18 years old
- Histological diagnosis of:
- Non-epithelial ovarian tumors Uterine sarcomas Vulvar cancer
Who cannot join
- Active HIV, HBV, or HCV infection Synchronous neoplasms Non-rare histologies of gynecological malignancies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Gemelli IRCCS
Rome
0630161
valentina Iacobelli, valentina.iacobelli@guest.policlinicogemelli.it
About this study
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.
Read more
The project will pursue this aim through the following activities:
- 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).
- 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.
- 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.
- Being tested
- DNA, RNA, ctDNA, metabolomics
- Medical subject headings
- Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA, RNA, ctDNA, metabolomicsGenetic
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Impact of molecular data on clinical management of rare gynecological cancers patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine SarcomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SCAMBIA GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582108
- Sponsor's protocol ID
- ID 6868
- Acronym
- ROAR
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UNDERSTANDING the RAREST GYNECOLOGICAL CANCERS: a MULTI -OMICS PLATFORM for IMPROVED PATIENTS MANAGEMENT
- ClinicalTrials.gov ID
- NCT06582108
- Acronym / sponsor ID
- ROAR / ID 6868
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients with non-epithelial ovarian tumors, 40 with uterine sarcomas, and 120 with vulvar tumors
Key inclusion criteria (3 listed)
- >18 years old
- Non-epithelial ovarian tumors Uterine sarcomas Vulvar cancer
Key exclusion criteria (1 listed)
- Active HIV, HBV, or HCV infection Synchronous neoplasms Non-rare histologies of gynecological malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA, RNA, ctDNA, metabolomicsThe 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 | Genetic | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Sarcoma and Vulvar Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Scambia (0630151, giovanni.scambia@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.