Describe Typical Gray Scale/Color Doppler Ultrasound Features of Gestational Trophoblastic Neoplasia at the US ExaminationTITANIUMNCT06284980
Gestional Trophoblastic Neoplasia Ultrasound Assessment: Titanium Study
An observational study of Describe Typical Gray Scale/Color Doppler Ultrasound Features of Gestational Trophoblastic Neoplasia at the US Examination and To Assess if There Are Differences at the Baseline US Scan Between Low-risk and High-risk Patients, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Describe Typical Gray Scale/Color Doppler Ultrasound Features of Gestational Trophoblastic Neoplasia at the US Examination, To Assess if There Are Differences at the Baseline US Scan Between Low-risk and High-risk Patients, To Identify Ultrasound Predictors of Resistance to First-line Single Drug Chemotherapy in Low-risk GTN Patients
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jan 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of Gestational Trophoblastic Neoplasia (GTN), after any kind of pregnancy (molar pregnancy, abortion, term pregnancy)
Who may be able to join
- Patients with a diagnosis of Gestational Trophoblastic Neoplasia (GTN), after any kind of pregnancy:
- Histological diagnosis of Placental Site Trophoblastic Tumor or Epithelioid Trophoblastic Tumor
- 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
- Charing Cross Hospital (UK) additional criteria for the diagnosis of Gestational Trophoblastic
- Neoplasia:
- 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.
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- 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.
Who cannot join
- Previous or ongoing chemotherapy for GTN that started >7 days earlier
- Denial of informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Rome, 00168
Floriana Mascilini, 0630156399, floriana.mascilini@policlinicogemelli.it
About this study
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.
Read the detailed description
Primary aim
- 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
- 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
- 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
- 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:
- To describe any longitudinal changes in ultrasound characteristics of Gestational Tropho-blastic Neoplasia during treatment.
- 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.
- Conditions
- Describe Typical Gray Scale/Color Doppler Ultrasound Features of Gestational Trophoblastic Neoplasia at the US Examination, To Assess if There Are Differences at the Baseline US Scan Between Low-risk and High-risk Patients, To Identify Ultrasound Predictors of Resistance to First-line Single Drug Chemotherapy in Low-risk GTN Patients, To Investigate if Machine Learning (ML) Algorithms (Radiomics, Deep Neural Networks (DNN), and Other Machine Learning Algorithms
- Keywords
- Gestational Trophoblastic Neoplasia, Ultrasound, Gestational
- Medical subject headings
- Gestational Trophoblastic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
typical features of Gestational Trophoblastic Neoplasia
To describe typical gray scale and color Doppler ultrasound features of Gestational Trophoblastic Neoplasia at the baseline US examination
Measured: 30 minutes
Secondary outcomes (1)
differences at the baseline US scan between low-risk and high-risk patients
US evaluation
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start24 Jan 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Describe Typical Gray Scale/Color Doppler Ultrasound Features of Gestational Trophoblastic Neoplasia at the US ExaminationStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mascilini Floriana, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Floriana Mascilini, Principal investigator, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284980
- Sponsor's protocol ID
- 2369
- Acronym
- TITANIUM
- Status last verified
- Feb 2023
- First submitted
- 22 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestional Trophoblastic Neoplasia Ultrasound Assessment: Titanium Study
- ClinicalTrials.gov ID
- NCT06284980
- Acronym / sponsor ID
- TITANIUM / 2369
- Conditions
- Describe Typical Gray Scale/Color Doppler Ultrasound Features of Gestational Trophoblastic Neoplasia at the US Examination, To Assess if There Are Differences at the Baseline US Scan Between Low-risk and High-risk Patients, To Identify Ultrasound Predictors of Resistance to First-line Single Drug Chemotherapy in Low-risk GTN Patients, To Investigate if Machine Learning (ML) Algorithms (Radiomics, Deep Neural Networks (DNN), and Other Machine Learning Algorithms
- Keywords
- Gestational Trophoblastic Neoplasia, Ultrasound, Gestational
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary aim
- 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
- 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
- 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
- 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:
- To describe any longitudinal changes in ultrasound characteristics of Gestational Tropho-blastic Neoplasia during treatment.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of Gestational Trophoblastic Neoplasia (GTN), after any kind of pregnancy (molar pregnancy, abortion, term pregnancy)
Key inclusion criteria (9 listed)
- Patients with a diagnosis of Gestational Trophoblastic Neoplasia (GTN), after any kind of pregnancy:
- 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.
Key exclusion criteria (2 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
typical features of Gestational Trophoblastic Neoplasia
Time frame: 30 minutes
To describe typical gray scale and color Doppler ultrasound features of Gestational Trophoblastic Neoplasia at the baseline US examination
1 secondary outcome
differences at the baseline US scan between low-risk and high-risk patients
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Floriana Mascilini principal investigator
Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Describe Typical Gray Scale/Color Doppler Ultrasound Features of Gestational Trophoblastic Neoplasia at the US Examination and To Assess if There Are Differences at the Baseline US Scan Between Low-risk and High-risk Patients, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonia Carla Testa (0630156399, antoniacarla.testa@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
typical features of Gestational Trophoblastic Neoplasia (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.