Uterine NeoplasmsNCT06774482
Evaluation of Toxicity and Outcomes of Different Therapeutic Strategies in Patients With Uterine Neoplasms
An observational study of Uterine Neoplasms, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The single-center observational study aims to collect data related to the radiation treatment of uterine neoplasms. The purpose of the study is to systematically gather data on radiation treatment in uterine neoplasms in order to evaluate tumor response and potential toxicity in relation to dosages, fractionation, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Neoplasms
- How many people
- 3,000 participants
- Where
- 1 siteItaly
- Study dates
- 19 May 2021to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Female patients, aged ≥ 18 years, with a new or previous diagnosis of malignant uterine neoplasm
Who may be able to join
- Female patients, aged ≥ 18 years, with a new or previous diagnosis of malignant uterine neoplasm, starting from 01/01/2000, treated at the Radiotherapy Unit of the Sant'Orsola Polyclinic
- Obtaining informed consent
Who cannot join
- Patients with a new or previous diagnosis of malignant uterine neoplasm who choose not to undergo radiation treatment at the Radiotherapy Unit of the Sant'Orsola Polyclinic
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, 40138
Alessio Giuseppe Morganti, MD, +39 0516363136, alessio.morganti2@unibo.it
Alessio Giuseppe Morganti, MD
About this study
Official title: Evaluation of Toxicity and Outcomes of Different Therapeutic Strategies in Patients With Uterine Neoplasms Treated With Radiotherapy at the Sant'Orsola Polyclinic in Bologna.
The single-center observational study aims to collect data related to the radiation treatment of uterine neoplasms. The purpose of the study is to systematically gather data on radiation treatment in uterine neoplasms in order to evaluate tumor response and potential toxicity in relation to dosages, fractionation, and techniques used, as well as the combination with other therapies and the characteristics of the disease.
Additionally, collecting data on both the characteristics of the disease and patients' comorbidities in a large sample may allow for the evaluation of any possible correlation with radiation-induced toxicities, with the aim of being able to predict and prevent them in a personalized manner in the future.
Read more
Therefore, the study's goal is to evaluate tumor response and any potential toxicity after radiotherapy treatment in relation to treatment settings, dosages, and techniques used, both for new diagnoses and for cases already diagnosed and treated from 01/01/2000 onwards at the Radiotherapy Unit of Sant'Orsola-Malpighi Polyclinic.
The structured collection of data necessary for the evaluation of the objectives will cover the observation period from 01/01/2000 to 15/12/2030, for a total of approximately 5000 patients.
Read the detailed description
Uterine neoplasms include endometrial cancer and cervical cancer. The former is the fourth most common cancer in women in Europe, while cervical cancer is the second most common cancer worldwide, especially in countries where population screening is not available.
Therapy for both is, in most cases, multimodal; the main therapeutic options include surgery, systemic therapy, and radiotherapy. The various treatments may play a role as primary, adjuvant, or neoadjuvant therapy depending on the neoplasm being treated and the strategy adopted in each case.
Regarding radiotherapy, it can be used alone or more frequently in combination with other treatments, especially in the radical treatment of cervical cancer. Radiotherapy may also play a role in metastatic disease, both with curative intent and to alleviate symptoms.
Dosages, fractionation, and techniques vary depending on the type of neoplasm being treated and the purpose of the therapy (adjuvant, neoadjuvant, radical, or palliative), as do the potential acute and late toxicities in relation to the characteristics of the treatment.
The aim of the study is to systematically collect data related to radiation treatment in uterine neoplasms to evaluate outcomes in relation to dosages, fractionation, and techniques used, the combination with other therapies, and the characteristics of the disease.
Moreover, collecting data on both the disease characteristics and treatments in a large sample may make it possible to evaluate any possible correlation with radiation-induced toxicities, in order to predict and prevent them in a personalized way in the future.
Patients enrolled in all phases of the study will not experience any direct benefit or harm from it, as it is solely a data collection effort. On the contrary, this data could lead to new knowledge that may improve the future management of the analyzed neoplastic diseases.
Thus, the goal of the study is to evaluate outcomes after radiotherapy treatment in relation to treatment settings, dosages, and techniques used, both for newly diagnosed cases and for those already diagnosed and treated since 01/01/2000 at the Radiotherapy Unit of the Sant'Orsola Polyclinic.
The structured collection of data necessary to evaluate the objectives will cover the observation period from 01/01/2000 to 15/12/2030, involving approximately 5000 patients (3000 for the retrospective phase and 2000 for the prospective phase).
The study is observational, retrospective and prospective, single-center, and spontaneous.
- Conditions
- Uterine Neoplasms
- Medical subject headings
- Uterine Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Local disease recurrence
To evaluate the outcome, particularly in terms of local disease recurrence, after radiation treatment of uterine neoplasms, in relation to the treatment setting, dosages, and techniques used, both for newly diagnosed neoplasms and for cases already diagnosed and treated since 01/01/2000 at the Sant'Orsola Polyclinic, Bologna University Hospital.
Measured: From the end of therapy to the last follow-up at 12 months
Secondary outcomes (5)
Acute toxicity
acute toxicity after radiotherapy, evaluated according to CTCAE v.5
Measured: immediate to 6 months after radiotherapy
Late toxicity
late toxicity after completion of treatments, evaluated according to CTCAE v.5
Measured: from 6 months after radiotherapy, through study completion, an average of 1 year
Incidence of retreatments and their characteristics
Measured: During follow ups through study completion, an average of 1 year
Disease-free survival of the patients
Disease-free survival assessed based on the presence or absence of local, nodal, or metastatic recurrences
Measured: During the follow-ups, up to the last one at 12 months
Overall survival
Measured: From enrollment to the last follow-up ar 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start19 May 2021
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine NeoplasmsStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessio Giuseppe Morganti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774482
- Sponsor's protocol ID
- ESTHER
- Status last verified
- Oct 2024
- First submitted
- 1 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Toxicity and Outcomes of Different Therapeutic Strategies in Patients With Uterine Neoplasms Treated With Radiotherapy at the Sant'Orsola Polyclinic in Bologna.
- ClinicalTrials.gov ID
- NCT06774482
- Acronym / sponsor ID
- ESTHER
- Conditions
- Uterine Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 Jan 2025 (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.
The single-center observational study aims to collect data related to the radiation treatment of uterine neoplasms. The purpose of the study is to systematically gather data on radiation treatment in uterine neoplasms in order to evaluate tumor response and potential toxicity in relation to dosages, fractionation, and techniques used, as well as the combination with other therapies and the characteristics of the disease.
Additionally, collecting data on both the characteristics of the disease and patients' comorbidities in a large sample may allow for the evaluation of any possible correlation with radiation-induced toxicities, with the aim of being able to predict and prevent them in a personalized manner in the future.
Therefore, the study's goal is to evaluate tumor response and any potential toxicity after radiotherapy treatment in relation to treatment settings, dosages, and techniques used, both for new diagnoses and for cases already diagnosed and treated from 01/01/2000 onwards at the Radiotherapy Unit of Sant'Orsola-Malpighi Polyclinic.
The structured collection of data necessary for the evaluation of the objectives will cover the observation period from 01/01/2000 to 15/12/2030, for a total of approximately 5000 patients.
Detailed description
Uterine neoplasms include endometrial cancer and cervical cancer. The former is the fourth most common cancer in women in Europe, while cervical cancer is the second most common cancer worldwide, especially in countries where population screening is not available.
Therapy for both is, in most cases, multimodal; the main therapeutic options include surgery, systemic therapy, and radiotherapy. The various treatments may play a role as primary, adjuvant, or neoadjuvant therapy depending on the neoplasm being treated and the strategy adopted in each case.
Regarding radiotherapy, it can be used alone or more frequently in combination with other treatments, especially in the radical treatment of cervical cancer. Radiotherapy may also play a role in metastatic disease, both with curative intent and to alleviate symptoms.
Dosages, fractionation, and techniques vary depending on the type of neoplasm being treated and the purpose of the therapy (adjuvant, neoadjuvant, radical, or palliative), as do the potential acute and late toxicities in relation to the characteristics of the treatment.
The aim of the study is to systematically collect data related to radiation treatment in uterine neoplasms to evaluate outcomes in relation to dosages, fractionation, and techniques used, the combination with other therapies, and the characteristics of the disease.
Moreover, collecting data on both the disease characteristics and treatments in a large sample may make it possible to evaluate any possible correlation with radiation-induced toxicities, in order to predict and prevent them in a personalized way in the future.
Patients enrolled in all phases of the study will not experience any direct benefit or harm from it, as it is solely a data collection effort. On the contrary, this data could lead to new knowledge that may improve the future management of the analyzed neoplastic diseases.
Thus, the goal of the study is to evaluate outcomes after radiotherapy treatment in relation to treatment settings, dosages, and techniques used, both for newly diagnosed cases and for those already diagnosed and treated since 01/01/2000 at the Radiotherapy Unit of the Sant'Orsola Polyclinic.
The structured collection of data necessary to evaluate the objectives will cover the observation period from 01/01/2000 to 15/12/2030, involving approximately 5000 patients (3000 for the retrospective phase and 2000 for the prospective phase).
The study is observational, retrospective and prospective, single-center, and spontaneous.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients, aged ≥ 18 years, with a new or previous diagnosis of malignant uterine neoplasm
Key inclusion criteria (2 listed)
- Female patients, aged ≥ 18 years, with a new or previous diagnosis of malignant uterine neoplasm, starting from 01/01/2000, treated at the Radiotherapy Unit of the Sant'Orsola Polyclinic
- Obtaining informed consent
Key exclusion criteria (1 listed)
- Patients with a new or previous diagnosis of malignant uterine neoplasm who choose not to undergo radiation treatment at the Radiotherapy Unit of the Sant'Orsola Polyclinic
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
Local disease recurrence
Time frame: From the end of therapy to the last follow-up at 12 months
To evaluate the outcome, particularly in terms of local disease recurrence, after radiation treatment of uterine neoplasms, in relation to the treatment setting, dosages, and techniques used, both for newly diagnosed neoplasms and for cases already diagnosed and treated since 01/01/2000 at the Sant'Orsola Polyclinic, Bologna University Hospital.
5 secondary outcomes
Acute toxicity
Time frame: immediate to 6 months after radiotherapy
Late toxicity
Time frame: from 6 months after radiotherapy, through study completion, an average of 1 year
Incidence of retreatments and their characteristics
Time frame: During follow ups through study completion, an average of 1 year
Disease-free survival of the patients
Time frame: During the follow-ups, up to the last one at 12 months
Overall survival
Time frame: From enrollment to the last follow-up ar 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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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.
Alessio Giuseppe Morganti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Uterine Neoplasms, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessio Giuseppe Morganti, MD (+39 0516363136, alessio.morganti2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local disease recurrence (time frame: From the end of therapy to the last follow-up at 12 months). 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 14 Jan 2025.