NCT06594471Not yet recruiting
Comprehensive Assessment of Clinical Characteristics and Outcomes of Gemelli Adolescents and Young Adults
Comprehensive Assessment of Characteristics and Outcomes of Gemelli Adolescents and Young Adults Diagnosed With Gynecological Cancer
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 5 Sept 2024
- Start date
- 9 Sept 2024
- Primary completion date
- 30 Sept 2039
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Childhood cancers
- NCT number
- NCT06594471
What you commit to
- Study type: Observational
- Planned participants: 500
- From 9 Sept 2024 to the primary completion date, 30 Sept 2039
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 15 years to 49 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.