Comprehensive Assessment of Characteristics and Outcomes of Gemelli Adolescents and Young Adults Diagnosed With Gynecological Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Clinical outcomes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Mentally disabled or patients with significantly altered mental status that would prohibit understanding and giving informed consent
- •Patients who do not provide informed consent on data collection and storage for scientific purposes
结局指标
主要结局
Clinical outcomes
时间窗: 10 years
The number of Adolescents and Young Adults diagnosed with gynecological cancer who receive treatment at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS hospital during a five-year period and their clinical characteristics, i.e., demographics, diagnosis, imaging, treatment and clinical trial participation.
次要结局
- Survival outcomes(10 years)
- Late-term physical effects - neurocognitive disorders(10 years)
- Late-term physical effects - auditory disorders(10 years)
- Late-term physical effects - ocular disorders(10 years)
- Late-term physical effects - oral/dental disorders(10 years)
- Late-term physical effects - dermatological disorders(10 years)
- Late-term physical effects - cardiovascular disorders(10 years)
- Late-term physical effects - pulmonary disorders(10 years)
- Late-term physical effects - gastro-intestinal disorders(10 years)
- Late-term physical effects - urinary tract disorders(10 years)
- Late-term physical effects - genital disorders(10 years)
- Late-term physical effects - endocrine/metabolic disorders(10 years)
- Late-term physical effects - musculoskeletal disorders(10 years)
- Late-term physical effects - neurological disorders(10 years)
- Late-term physical effects - immune disorders(10 years)
- Late-term physical effects - subsequent malignant neoplasms(10 years)
- Sexual outcomes - Body Appreciation Scale-2(10 years)
- Sexual outcomes - Sexual Adjustment and Body Image Scale in Gynecological cancer (SABIS-G)(10 years)
- Sexual outcomes - Female Sexual Function Index (FSFI)(10 years)
- Sexual outcomes - EORTC Sexual Health (SH-22) questionnaire(10 years)
- Reproductive outcomes - fertility preservation(10 years)
- Reproductive outcomes - Decision Regret Scale (DRS)(10 years)
- Reproductive outcomes - Reproductive Concerns After Cancer (RCAC) scale(10 years)
- Reproductive outcomes - Iatrogenic menopause(10 years)
- Reproductive outcomes - Menopause Quality of Life (MenQoL) questionnaire(10 years)
- Psychological outcomes - EORTC-C30 general quality of life questionnaire(10 years)
- Psychological outcomes - Clinical outcomes in Routine Evaluation (CORE-OM)(10 years)
- Psychological outcomes - Ten Item Personality Inventory (TIPI)(10 years)
- Psychological outcomes - Hospital Anxiety and Depression Scale (HADS)(10 years)
- Psychological outcomes - Distress thermometer(10 years)
- Psychological outcomes - General Self-Efficacy (GSE) Scale(10 years)
- Psychological outcomes - Mini-Mental Adjustment to Cancer (Mini-MAC)(10 years)
- Psychological outcomes - Cancer Worry Scale (CWS)(10 years)
- Psychological outcomes - Multidimensional Scale of Perceived Social Support (MSPSS)(10 years)
- Psychological outcomes - Patient Health Engagement scale(10 years)
- Psychological outcomes - Supportive Care Needs Survey-Short Form (SCNS-SF34)(10 years)
- Social outcomes - Medical Consumption Questionnaire (iMCQ)(10 years)
- Social outcomes - Productivity Cost Questionnaire (iPCQ)(10 years)
- Social outcomes - Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) tool(10 years)