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Not yet recruiting NCT06594471

Comprehensive Assessment of Clinical Characteristics and Outcomes of Gemelli Adolescents and Young Adults

— Observational Gynecologic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire on late-term physical effects, Questionnaire on sexual and reproductive health outcomes, Questionnaire on psychological outcomes, Questionnaire on social outcomes.
Who it may be relevant to
Registry conditions: Gynecologic Cancer. Basic parameters: 15 years — 49 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comprehensive Assessment of Characteristics and Outcomes of Gemelli Adolescents and Young Adults Diagnosed With Gynecological Cancer

Overview

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.

Interventions

  • Other Questionnaire on late-term physical effects
    Patients will be asked to indicate any potential late-term physical effects following cancer treatment: neurocognitive, auditory, ocular, oral/dental, dermatologic, cardiovascular, pulmonary, gastro-intestinal, urinary tract, genital, endocrine/metabolic, musculoskeletal, neurological, immune disorders and occurrence of any subsequent malignant neoplasms.
  • Other Questionnaire on sexual and reproductive health outcomes
    Patients will be asked to complete the following questionnaires: Body Appreciation Scale-2 (BAS-2), Body Image Scale (BIS), EORTC QLQ-SH22, Body Image Scale in Gynecological Cancer (SABIS-G). Patients who underwent a fertility-sparing procedure will be asked to fill out the Reproductive Concerns after Cancer (RCAC) and Decision Regret Scale (DRS), whereas those who experienced iatrogenic menopause will complete the MENQOL questionnaire to assess menopause-related quality of life.
  • Other Questionnaire on psychological outcomes
    Patients will be asked to complete the following questionaires: EORTC QLQ-C30, Clinical outcomes in Routine Evaluation (CORE-OM), Ten Item Personality Inventory (TIPI), Hospital Anxiety and Depression Scale (HADS), General Self-Efficacy (GSE) Scale, Mini-Mental Adjustment to Cancer (Mini-MAC), Cancer Worry Scale (CWS), Multidimensional Scale of Perceived Social Support (MSPSS), the Patient Health Engagement scale and the Supportive Care Needs Survey-Short Form (SCNS-SF34).
  • Other Questionnaire on social outcomes
    Patients will be asked to complete the following questionaires: Medical Consumption Questionnaire (iMCQ), Productivity Cost Questionnaire (iPCQ) and the Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) questionnaire.

Primary outcome measures

  • Clinical outcomes [Time frame: 10 years]
Secondary outcome measures (12)
  • Survival outcomes [Time frame: 10 years]
  • Late-term physical effects - neurocognitive disorders [Time frame: 10 years]
  • Late-term physical effects - auditory disorders [Time frame: 10 years]
  • Late-term physical effects - ocular disorders [Time frame: 10 years]
  • Late-term physical effects - oral/dental disorders [Time frame: 10 years]
  • Late-term physical effects - dermatological disorders [Time frame: 10 years]
  • Late-term physical effects - cardiovascular disorders [Time frame: 10 years]
  • Late-term physical effects - pulmonary disorders [Time frame: 10 years]
  • Late-term physical effects - gastro-intestinal disorders [Time frame: 10 years]
  • Late-term physical effects - urinary tract disorders [Time frame: 10 years]
  • Late-term physical effects - genital disorders [Time frame: 10 years]
  • Late-term physical effects - endocrine/metabolic disorders [Time frame: 10 years]

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC GINECOLOGIA ONCOLOGICA — Roma

Identifiers

NCT: NCT06594471 · ID 6432

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗