Gestional Trophoblastic Neoplasia Ultrasound Assessment: Titanium Study

Last updated: February 22, 2024
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gestational Trophoblastic Neoplasia

Neoplasms

Treatment

N/A

Clinical Study ID

NCT06284980
2369
  • Ages > 18
  • Female

Study Summary

Gestational trophoblast diseases are characterized by abnormal proliferation of trophoblastic tissue, which can occur consequent to any pregnancy event. Pre-malignant forms (partial hydatiform mola and complete mola) and malignant forms are distinguished, the latter also known as gestational trophoblast neoplasms (invasive hydatiform mola, choriocarcinoma, placental site trophoblastic tumor, and epithelioid trophoblastic tumor).

These are neoplasms associated with good prognosis, amenable to conservative treatment and highly sensitive to chemotherapy.

The identification of ultrasonographic and echofluximetric features typical of malignant forms as well as the identification of ultrasonographic parameters predictive of chemoresistance to single-drug treatments could help improve their management.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a diagnosis of Gestational Trophoblastic Neoplasia (GTN), after any kindof pregnancy:
  1. Histological diagnosis of Placental Site Trophoblastic Tumor or EpithelioidTrophoblastic Tumor
  2. International Federation of Gynecology and Obstetrics (FIGO) 2002 criteria forthe diagnosis of Gestational Trophoblastic Neoplasia I. Histological evidence ofinvasive mole or choriocarcinoma II. Rising hCG after evacuation of hydatidiformmole, 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
  1. III. Plateau of hCG after evacuation of hydatidiform mole, i.e. four or moreequivalent values of hCG over at least 3 weeks (days 1, 7, 14 and 21) IV. The hCGlevel remains elevated for 6 months or more after evacuation even if decreasing
  1. Charing Cross Hospital (UK) additional criteria for the diagnosis of GestationalTrophoblastic Neoplasia: I. Heavy vaginal bleeding or evidence of gastrointestinal or intraperitonealhemorrhage in patients with histological diagnosis of GTD II. Serum hCGconcentration 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 onchest radiograph in patients with GTD. Referral Centers for Gestational Trophoblastic Disease with at least 5 cases ofGTN per year, that routinely use ultrasound in clinical evaluation, couldparticipate in the study adhering to the:
  • BASIC PROTOCOL if they are able to guarantee only the baseline ultrasound evaluationat 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-upultrasound examination according to the complete protocol schedule.

Exclusion

Exclusion Criteria:

  • EXCLUSION CRITERIA
  1. Previous or ongoing chemotherapy for GTN that started >7 days earlier
  2. Denial of informed consent.

Study Design

Total Participants: 120
Study Start date:
January 24, 2019
Estimated Completion Date:
December 31, 2025

Study Description

Primary aim

  1. To describe typical gray scale and color Doppler ultrasound features of Gestational Troph-oblastic Neoplasia at the baseline US examination; the results will be presented as in Table 4

  2. To assess if there are differences at the baseline US scan between low-risk and high-risk patients and, in the low-risk group, between responders and non-responders to the single drug therapy; the results will be presented as in Table 5

  3. To identify ultrasound predictors of resistance to first-line single drug chemotherapy in low-risk GTN patients; statistical analysis will be performed using logistic regression mod-eling

  4. To investigate if machine learning (ML) algorithms (radiomics, deep neural networks (DNN), and other machine learning algorithms), applied on ultrasound images, can dis-criminate between low-risk patients that will or will not develop chemoresistance to single-drug therapy.To investigate if ML algorithms, combined with the conventional risk-score improve prediction of resistance to first-line single drug chemotherapy in low risk GTN pa-tients.

Secondary aims:

I. To describe any longitudinal changes in ultrasound characteristics of Gestational Tropho-blastic Neoplasia during treatment.

I. To describe any longitudinal changes in ultrasound characteristics of Gestational Tropho-blastic Neoplasia after stopping treatment, when the uterine lesion is still visible despite the normalization of hCG.

Connect with a study center

  • Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

    Rome, 00168
    Italy

    Active - Recruiting

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