Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594471
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Comprehensive Assessment of Clinical Characteristics and Outcomes of Gemelli Adolescents and Young Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comprehensive Assessment of Characteristics and Outcomes of Gemelli Adolescents and Young Adults Diagnosed With Gynecological Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
G-AYA
Brief Summary:
The Adolescent and Young Adults cancer population encompass patients diagnosed with oncological disease at the age of 15-39 years Although 86 of these patients become long-term cancer survivors studies have shown that these survival rates lag behind to those of younger and older patients The underlying reason for this discrepancy is however yet poorly understood Furthermore these patients may be more often confronted with late effects due to their disease andor anticancer treatment Knowledge on Adolescent and Young Adults diagnosed with gynecological cancer at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS hospital in Rome Italy is currently lacking and is needed to deliver these patients the best possible care tailored to their disease characteristics and specific needs
The primary objective of this monocenter observational study is to determine the number of Gemelli Adolescent and Young Adults diagnosed with gynecological cancer and their clinical characteristics Secondary objectives will be to determine their oncological late-term physical effects sexual and reproductive health psychological and social outcomes Tertiary outcomes will be to compare the clinical characteristics and oncological outcomes of Gemelli Adolescents and Young Adults to patients beyond this age-specific cohort who have been treated during the same study period
The primary objective of this monocenter observational study is to determine the number of Gemelli Adolescent and Young Adults diagnosed with gynecological cancer and their clinical characteristics Secondary objectives will be to determine their oncological late-term physical effects sexual and reproductive health psychological and social outcomes Tertiary outcomes will be to compare the clinical characteristics and oncological outcomes of Gemelli Adolescents and Young Adults to patients beyond this age-specific cohort who have been treated during the same study period
Detailed Description:
Clinical diagnosis and treatment characteristics will be determined In addition oncological eg disease-free and overall survival late-term physical eg cardiovascular second primary tumor sexual and reproductive health eg body image sexual functioning fertility preservation pregnancy rate premature ovarian insufficiency psychological eg anxiety and depression and social eg unemployment financial toxicity outcomes will be determined
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