Gestional Trophoblastic Neoplasia Ultrasound Assessment: Titanium Study

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Feb 22, 2024

Keywords

ClinConnect Summary

The Gestational Trophoblastic Neoplasia Ultrasound Assessment: Titanium Study is a clinical trial that aims to improve how we understand and treat certain pregnancy-related tumors known as gestational trophoblastic neoplasia (GTN). These tumors can occur after any type of pregnancy and are generally responsive to treatment, often with good outcomes. The study focuses on identifying specific ultrasound features of GTN that could help doctors determine whether a patient is at low or high risk and predict how well they might respond to single-drug chemotherapy. Researchers will also explore the use of machine learning to analyze ultrasound images for better diagnosis and treatment planning.

This study is currently recruiting female participants aged 65-74 who have been diagnosed with GTN, specifically those with certain types of tumors or specific test results indicating the presence of the disease. Participants can expect to undergo baseline ultrasound examinations to assess their condition. It's important to note that individuals who have started chemotherapy for GTN within the past week or do not provide informed consent cannot take part in the trial. This research could lead to improved management of GTN and better outcomes for patients in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• * Patients with a diagnosis of Gestational Trophoblastic Neoplasia (GTN), after any kind of pregnancy:
• • 1. Histological diagnosis of Placental Site Trophoblastic Tumor or Epithelioid Trophoblastic Tumor
• • 2. International Federation of Gynecology and Obstetrics (FIGO) 2002 criteria for the diagnosis of Gestational Trophoblastic Neoplasia I. Histological evidence of invasive mole or choriocarcinoma II. Rising hCG after evacuation of hydatidiform mole, i.e. two consecutive rises in hCG of 10% or greater over at least 2 weeks (at least 10% between day 1 and 7 and then again at least 10% between day 7 and 14) III. Plateau of hCG after evacuation of hydatidiform mole, i.e. four or more equivalent values of hCG over at least 3 weeks (days 1, 7, 14 and 21) IV. The hCG level remains elevated for 6 months or more after evacuation even if decreasing
• • 3. Charing Cross Hospital (UK) additional criteria for the diagnosis of Gestational Trophoblastic
• Neoplasia:
• • I. Heavy vaginal bleeding or evidence of gastrointestinal or intraperitoneal hemorrhage in patients with histological diagnosis of GTD II. Serum hCG concentration of 20 000 IU/L or more 4 weeks or more after evacuation of a mole, because of the risk of uterine perforation III. Evidence of metastases in brain, liver, or gastrointestinal tract, or radiological opacities larger than 2 cm on chest radiograph in patients with GTD.
• Referral Centers for Gestational Trophoblastic Disease with at least 5 cases of GTN per year, that routinely use ultrasound in clinical evaluation, could participate in the study adhering to the:
• • BASIC PROTOCOL if they are able to guarantee only the baseline ultrasound evaluation at the diagnosis but NOT the follow-up ultrasound scans during and after chemotherapy
• • FULL PROTOCOL if they are able to guarantee both the baseline and all the follow-up ultrasound examination according to the complete protocol schedule.
• Exclusion Criteria:
• • EXCLUSION CRITERIA
• • 1. Previous or ongoing chemotherapy for GTN that started \>7 days earlier
• • 2. Denial of informed consent.