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

NCT06594471 | Not Yet Recruiting

• 1 other identifier: ID 6432
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical outcomes

  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.

  10 years

Secondary Outcomes (39)

• 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

Other Outcomes (2)

• Comparison of clinical characteristics with patients beyond this age-specific cohort

  10 years

• Comparison of oncological outcomes with patients beyond this age-specific cohort

  10 years

Interventions

Questionnaire on late-term physical effects OTHER

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.

Questionnaire on sexual and reproductive health outcomes OTHER

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.

Questionnaire on psychological outcomes OTHER

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).

Questionnaire on social outcomes OTHER

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.

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC GINECOLOGIA ONCOLOGICA

Roma, 00168, Italy

Location

Study Officials

• Giovanni Scambia

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Scambia

CONTACT

+390630155701; giovanni.scambia@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): September 30, 2039
• Study Completion (Estimated): March 31, 2040
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IT (1)