Clinical trial NCT06594471: Comprehensive Assessment of Clinical Characteristics and Outcomes of Gemelli Adolescents and Young Adults
Official title: Comprehensive Assessment of Characteristics and Outcomes of Gemelli Adolescents and Young Adults Diagnosed With Gynecological Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gynecologic Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 500
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be included who are diagnosed with gynecological cancer of any tumor type at the age of 15-39 years and have been treated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS hospital in Rome, Italy.

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 and/or 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.

Detailed description: Clinical, diagnosis and treatment characteristics will be determined. In addition, oncological (e.g., disease-free and overall survival), late-term physical (e.g., cardiovascular, second primary tumor), sexual and reproductive health (e.g., body image, sexual functioning, fertility preservation, pregnancy rate, premature ovarian insufficiency), psychological (e.g., anxiety and depression) and social (e.g. (un)employment, financial toxicity) outcomes will be determined.

Eligibility criteria: Inclusion Criteria:

Gynecological cancer types include but are not limited to the following:

* Ovarian cancer - borderline tumors with invasive peritoneal implants, epithelial carcinoma (endometrioid, clear cell, high-grade serous, low-grade serous, mucinous, undifferentiated), germ cell tumor (dysgerminoma, immature teratomas, yolk sac tumors, embryonal carcinomas, carcinoid tumors), sex cord stromal tumor (gynandroblastoma, granulosa cell tumor, Sertoli-Leydig cell tumor, steroid cell tumor)
* Cervical cancer - squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, carcinoma in situ with stromal microinvasion (to be considered as microinvasive carcinoma), other
* Endometrial cancer - endometrioid, papillary serous, clear cell, carcinosarcoma
* Sarcoma - uterine sarcoma (incl. leiomyosarcoma, endometrial stromal sarcoma, adenosarcoma)
* Gestational trophoblastic neoplasms - invasive mole, choriosarcoma, placental site trophoblastic tumor, epithelioid trophoblastic tumor, other
* Vulvar-vaginal cancer - squamous cell carcinoma, M. Paget, other

Exclusion Criteria:

1. Mentally disabled or patients with significantly altered mental status that would prohibit understanding and giving informed consent
2. Patients who do not provide informed consent on data collection and storage for scientific purposes

Primary outcomes:
measure: Clinical outcomes
timeFrame: 10 years
Secondary outcomes:
measure: Survival outcomes
timeFrame: 10 years
measure: Late-term physical effects - neurocognitive disorders
timeFrame: 10 years
measure: Late-term physical effects - auditory disorders
timeFrame: 10 years
measure: Late-term physical effects - ocular disorders
timeFrame: 10 years
measure: Late-term physical effects - oral/dental disorders
timeFrame: 10 years
measure: Late-term physical effects - dermatological disorders
timeFrame: 10 years
measure: Late-term physical effects - cardiovascular disorders
timeFrame: 10 years
measure: Late-term physical effects - pulmonary disorders
timeFrame: 10 years
measure: Late-term physical effects - gastro-intestinal disorders
timeFrame: 10 years
measure: Late-term physical effects - urinary tract disorders
timeFrame: 10 years
measure: Late-term physical effects - genital disorders
timeFrame: 10 years
measure: Late-term physical effects - endocrine/metabolic disorders
timeFrame: 10 years
measure: Late-term physical effects - musculoskeletal disorders
timeFrame: 10 years
measure: Late-term physical effects - neurological disorders
timeFrame: 10 years
measure: Late-term physical effects - immune disorders
timeFrame: 10 years
measure: Late-term physical effects - subsequent malignant neoplasms
timeFrame: 10 years
measure: Sexual outcomes - Body Appreciation Scale-2
timeFrame: 10 years
measure: Sexual outcomes - Sexual Adjustment and Body Image Scale in Gynecological cancer (SABIS-G)
timeFrame: 10 years
measure: Sexual outcomes - Female Sexual Function Index (FSFI)
timeFrame: 10 years
measure: Sexual outcomes - EORTC Sexual Health (SH-22) questionnaire
timeFrame: 10 years
measure: Reproductive outcomes - fertility preservation
timeFrame: 10 years
measure: Reproductive outcomes - Decision Regret Scale (DRS)
timeFrame: 10 years
measure: Reproductive outcomes - Reproductive Concerns After Cancer (RCAC) scale
timeFrame: 10 years
measure: Reproductive outcomes - Iatrogenic menopause
timeFrame: 10 years
measure: Reproductive outcomes - Menopause Quality of Life (MenQoL) questionnaire
timeFrame: 10 years
measure: Psychological outcomes - EORTC-C30 general quality of life questionnaire
timeFrame: 10 years
measure: Psychological outcomes - Clinical outcomes in Routine Evaluation (CORE-OM)
timeFrame: 10 years
measure: Psychological outcomes - Ten Item Personality Inventory (TIPI)
timeFrame: 10 years
measure: Psychological outcomes - Hospital Anxiety and Depression Scale (HADS)
timeFrame: 10 years
measure: Psychological outcomes - Distress thermometer
timeFrame: 10 years
measure: Psychological outcomes - General Self-Efficacy (GSE) Scale
timeFrame: 10 years
measure: Psychological outcomes - Mini-Mental Adjustment to Cancer (Mini-MAC)
timeFrame: 10 years
measure: Psychological outcomes - Cancer Worry Scale (CWS)
timeFrame: 10 years
measure: Psychological outcomes - Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 10 years
measure: Psychological outcomes - Patient Health Engagement scale
timeFrame: 10 years
measure: Psychological outcomes - Supportive Care Needs Survey-Short Form (SCNS-SF34)
timeFrame: 10 years
measure: Social outcomes - Medical Consumption Questionnaire (iMCQ)
timeFrame: 10 years
measure: Social outcomes - Productivity Cost Questionnaire (iPCQ)
timeFrame: 10 years
measure: Social outcomes - Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) tool
timeFrame: 10 years
Other outcomes:
measure: Comparison of clinical characteristics with patients beyond this age-specific cohort
timeFrame: 10 years
measure: Comparison of oncological outcomes with patients beyond this age-specific cohort
timeFrame: 10 years
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC GINECOLOGIA ONCOLOGICA
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Giovanni Scambia
role: PRINCIPAL_INVESTIGATOR
References: