EndometriosisNCT06787365
Questionnaire for the Assessment of Risk Factors Associated with Endometriosis in Adolescent Women with Endometriosis
An observational study of Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial summary
A number of risk factors that may be associated with endometriosis in adolescents (medical history and symptoms) are reported in the literature, but no overall estimate of disease risk has been developed. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 300 participants
- Where
- 2 sitesItaly
- Study dates
- Feb 2025to Apr 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with and without a diagnosis of endometriosis
Who may be able to join
- Women of childbearing age between 20 and 50 years
- Clinical and ultrasound diagnosis of endometriosis for the study group and exclusion of endometriosis for the control group (examination and ultrasound performed according to the IDEA study criteria)
- Acquisition of informed consent for participation in the study and processing of personal data
Who cannot join
- Women suffering from other conditions responsible for pelvic pain (uterine fibromatosis, current or previous pelvic inflammatory disease, ovarian cysts of a non-endometriotic nature, irritable bowel syndrome, inflammatory bowel disease, interstitial cystitis)
Trial locations and contacts
2 sites in 1 country.
Roberto Palermo, MD contact
Italy2 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Simona Del Forno, MD, +390512143494, simona.delforno@aosp.bo.it
Simona Del Forno, MD
Azienda Ospedaliero-Universitaria Senese
Siena, Siena, 53100
Lucia Lazzeri, MD, +393346887383, lazzeri13@unisi.it
About this study
Official title: Questionnaire for the Assessment of Risk Factors Associated with Endometriosis in Adolescent Women Diagnosed with Endometriosis
A number of risk factors that may be associated with endometriosis in adolescents (medical history and symptoms) are reported in the literature, but no overall estimate of disease risk has been developed.
Providing a tool for assessing risk factors associated with endometriosis in adolescents by estimating disease risk could aid the clinician in diagnosis and reduce diagnostic delay
Read the detailed description
Although more than 60% of adult women with endometriosis report that their painful symptoms appeared before the age of 20, early diagnosis, particularly in adolescent girls, is still a challenge for doctors. The reasons for this delay include inadequate knowledge of the disease among healthcare professionals, the social and health normalisation of menstrual pain, and the peculiar aspects of the disease in adolescent patients. The adolescent patient with endometriosis presents particular anamnestic, familial and personal risk factors, as well as peculiar symptoms such as non-specific abdominal pain, acyclic pelvic pain, gastrointestinal symptoms, migraine, in addition to those classically reported in adulthood.
It may therefore be useful to identify a predictive model of the onset of endometriosis based on the risk factors currently recognised in the literature (anamnestic data) and on the results of a questionnaire to be submitted to adult women (aged between 20 and 50 years), with endometriosis (group 1) and without a diagnosis of endometriosis (group 2), concerning symptoms experienced in adolescence
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Gynaecology, Questionnaire, Risk factors, Painful symptoms
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with endometriosis | |
| Control group | Patients without endometriosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive model of endometriosis onset risk
Predictive model of the occurrence of endometriosis based on the risk factors currently recognised in the literature (anamnestic data) and the results of a questionnaire consists of 28 multiple-choice questions, concerning symptoms experienced in adolescence
Measured: During the first visit after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simona Del Forno, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787365
- Sponsor's protocol ID
- QuestionENDO
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 22 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Questionnaire for the Assessment of Risk Factors Associated with Endometriosis in Adolescent Women Diagnosed with Endometriosis
- ClinicalTrials.gov ID
- NCT06787365
- Acronym / sponsor ID
- QuestionENDO
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Gynaecology, Questionnaire, Risk factors, Painful symptoms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 22 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.
A number of risk factors that may be associated with endometriosis in adolescents (medical history and symptoms) are reported in the literature, but no overall estimate of disease risk has been developed.
Providing a tool for assessing risk factors associated with endometriosis in adolescents by estimating disease risk could aid the clinician in diagnosis and reduce diagnostic delay
Detailed description
Although more than 60% of adult women with endometriosis report that their painful symptoms appeared before the age of 20, early diagnosis, particularly in adolescent girls, is still a challenge for doctors. The reasons for this delay include inadequate knowledge of the disease among healthcare professionals, the social and health normalisation of menstrual pain, and the peculiar aspects of the disease in adolescent patients. The adolescent patient with endometriosis presents particular anamnestic, familial and personal risk factors, as well as peculiar symptoms such as non-specific abdominal pain, acyclic pelvic pain, gastrointestinal symptoms, migraine, in addition to those classically reported in adulthood.
It may therefore be useful to identify a predictive model of the onset of endometriosis based on the risk factors currently recognised in the literature (anamnestic data) and on the results of a questionnaire to be submitted to adult women (aged between 20 and 50 years), with endometriosis (group 1) and without a diagnosis of endometriosis (group 2), concerning symptoms experienced in adolescence
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Patients with endometriosis |
| Control group | – | –Patients without endometriosis |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with and without a diagnosis of endometriosis
Key inclusion criteria (3 listed)
- Women of childbearing age between 20 and 50 years
- Clinical and ultrasound diagnosis of endometriosis for the study group and exclusion of endometriosis for the control group (examination and ultrasound performed according to the IDEA study criteria)
- Acquisition of informed consent for participation in the study and processing of personal data
Key exclusion criteria (1 listed)
- Women suffering from other conditions responsible for pelvic pain (uterine fibromatosis, current or previous pelvic inflammatory disease, ovarian cysts of a non-endometriotic nature, irritable bowel syndrome, inflammatory bowel disease, interstitial cystitis)
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
Predictive model of endometriosis onset risk
Time frame: During the first visit after enrollment
Predictive model of the occurrence of endometriosis based on the risk factors currently recognised in the literature (anamnestic data) and the results of a questionnaire consists of 28 multiple-choice questions, concerning symptoms experienced in adolescence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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. This study is not recruiting at the moment.
Roberto Palermo, MD contact
Simona Del Forno, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 22 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 2 sites 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 Simona Del Forno, MD (+390512143494, simona.delforno@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive model of endometriosis onset risk (time frame: During the first visit after enrollment). 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 22 Jan 2025.