Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582108
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
UNDERSTANDING the RAREST GYNECOLOGICAL CANCERS a MULTI -OMICS PLATFORM for IMPROVED PATIENTS MANAGEMENT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
UNDERSTANDING the RAREST GYNECOLOGICAL CANCERS a MULTI -OMICS PLATFORM for IMPROVED PATIENTS MANAGEMENT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROAR
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 andor 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 WP2Task1 developing a dedicated electronic customized research form WP2Task2 and deploying a genomics platform WP2Task3
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 WP3WP4 standardization of pre-analytical and sequencing procedures WP56 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 WP7Task 11 integrating -omics data in the board report WP7Task 12 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
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 WP2Task1 developing a dedicated electronic customized research form WP2Task2 and deploying a genomics platform WP2Task3
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 WP3WP4 standardization of pre-analytical and sequencing procedures WP56 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 WP7Task 11 integrating -omics data in the board report WP7Task 12 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None