Endometrial PolypNCT00247923
Endometrial Polyps: Pathophysiology and Clinical Consequences
A study testing Hysteroscopic resection of endometrial polyps. (TCRP) in people with Endometrial Polyp and Endometrial Cancer, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
The aim of these studies is to study the natural history, the symptoms of, as well as the effect of hysteroscopic resection of endometrial polyps. Furthermore, another aim is to study new diagnostic techniques to differentiate between malignant and benign endometrial polyps. Read more about this study
- Who is it for?
- Ages 16 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Polyp, Endometrial Cancer
- What is being tested?
- Hysteroscopic resection of endometrial polyps. (TCRP)
- Type of treatment
- Surgery or procedure
- How many people
- 1,186 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2005to Feb 2009
- Phase
- Interventional
- 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 16 to 90 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Study 1:
- Endometrial polyp (EP) group: Presence of endometrial polyp verified by vaginal ultrasound examination.
- Cancer group: Presence of endometrial cancer verified by histological examination.
- Study 2:
- Pre- or perimenopausal women.
- Presence of endometrial polyp verified by vaginal ultrasound.
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- Study 3:
- EP group: Presence of endometrial polyp verified by vaginal ultrasound.
- Control group: Normal endometrium by vaginal ultrasound examination.
Who cannot join
- Study 1: Earlier severe allergic reactions.
- Study 2:
- Postmenopausal patient.
- Pregnancy.
- Additional condition requiring treatment detected during examination. Malignancy or atypical hyperplasia detected by histological examination.
- Study 3:
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- Previous hysterectomy.
- Pregnancy.
- Additional condition requiring treatment detected during examination. Malignancy or atypical hyperplasia detected by histological examination.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Gynaecologial department, Ullevaal University Hospital
Oslo, Oslo, 0407
About this study
Official title: Endometrial Polyps. Pathophysiology and Clinical Consequences.
The aim of these studies is to study the natural history, the symptoms of, as well as the effect of hysteroscopic resection of endometrial polyps. Furthermore, another aim is to study new diagnostic techniques to differentiate between malignant and benign endometrial polyps.
Read the detailed description
Study Part 1: New diagnostic methods for the prediction of malignancy in endometrial polyps: A prospective pilot study.
Study of angiogenesis by identification of specific angiogenesis factors in tissue biopsies from the endometrium and by Doppler ultrasound combined with IV contrast. We hope to find specific characteristics with new vessel formation in the endometrial polyp, which can play a role in the prognostic evaluation regarding the risk for cancer development. We will compare women with endometrial polyps and women with endometrial cancer to see if these methods of angiogenesis evaluation may be useful in separating benign polyps from premalignant and malignant polyps.
Study Part 2: The natural history of endometrial polyps. A prospective randomised study of patients with endometrial polyps.
Blood loss during menstruation is documented with the help of a standardized form (PBAC). The patients are randomized to hysteroscopic resection of the endometrial polyp or 6 months of observation. A new registration of blood loss during menstruation is performed by patients in both groups. In the intervention group, a new gynaecological examination 6 months after the resection documents the presence of residual polyp or symptoms. The other group is examined again after 6 months of observation. Symptoms and findings with the second examination are compared with symptoms and findings at the first examination, any changes are documented and the final outcome in the to groups are compared.
Study Part 3: The occurrence and natural history of asymptomatic endometrial polyps in perimenopausal women. A prospective controlled study.
Registration of blood loss during menstruation is documented with the help of a standardized form (PBAC) and gynaecological examination including SIS of 1000 randomly selected women in the age group 45-50. Where endometrial polyps are identified, we document the size and number of polyps and an endometrial biopsy is taken. After including a woman with an endometrial polyp in the study, the next woman without endometrial polyp is recruited to the control group. After one year, blood loss during menstruation is registered again, and all women with endometrial polyps as well as the control group have a new examination including vaginal ultrasound, SIS and endometrial biopsy. Symptoms and findings are compared with symptoms and findings at the first examination and all changes are documented. If the woman has a persistent endometrial polyp when examined at 1 year, she is offered treatment with hysteroscopic polyp resection.
- Conditions
- Endometrial Polyp, Endometrial Cancer
- Being tested
- Hysteroscopic resection of endometrial polyps. (TCRP)
- Keywords
- Endometrial polyps., Angiogenesis., Asymptomatic., Symptoms., Malignancy., Treatment efficiency., Vaginal bleeding.
- Medical subject headings
- Endometrial Neoplasms, Neoplasms, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic resection of endometrial polyps. (TCRP)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Study part 1. Angiogenesis factor levels in endometrial biopsies in patients with endometrial polyps compared to patients with endometrial cancer
Resistance in the feeding vessel measured by doppler examination combined with intravenous (i.v.) contrast in patients with endometrial polyps and endometrial cancer
Study part 2. Change in pictorial blood loss assessment chart (PBAC) score in intervention compared to observation group
Study part 3. Change in PBAC score in women with endometrial polyps compared to control group
Secondary outcomes (2)
Associated factors for the development of endometrial polyps
Change in endometrial polyp size and symptoms after 6 and 12 months of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startOct 2005
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial PolypStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Olav Istre, MD., PhD., Principal investigator, Department og Gynaecology, Ullevaal University Hospital, Oslo, Norway.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247923
- Sponsor's protocol ID
- PP I/II/III
- Other IDs
- 22200205
- Status last verified
- Feb 2009
- First submitted
- 31 Oct 2005
- Last updated
- 6 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Polyps. Pathophysiology and Clinical Consequences.
- ClinicalTrials.gov ID
- NCT00247923
- Acronym / sponsor ID
- PP I/II/III
- Conditions
- Endometrial Polyp, Endometrial Cancer
- Keywords
- Endometrial polyps., Angiogenesis., Asymptomatic., Symptoms., Malignancy., Treatment efficiency., Vaginal bleeding.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,186 participants (estimated)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Feb 2009 (actual)
- First posted
- 2 Nov 2005 (estimated)
- 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 aim of these studies is to study the natural history, the symptoms of, as well as the effect of hysteroscopic resection of endometrial polyps. Furthermore, another aim is to study new diagnostic techniques to differentiate between malignant and benign endometrial polyps.
Detailed description
Study Part 1: New diagnostic methods for the prediction of malignancy in endometrial polyps: A prospective pilot study.
Study of angiogenesis by identification of specific angiogenesis factors in tissue biopsies from the endometrium and by Doppler ultrasound combined with IV contrast. We hope to find specific characteristics with new vessel formation in the endometrial polyp, which can play a role in the prognostic evaluation regarding the risk for cancer development. We will compare women with endometrial polyps and women with endometrial cancer to see if these methods of angiogenesis evaluation may be useful in separating benign polyps from premalignant and malignant polyps.
Study Part 2: The natural history of endometrial polyps. A prospective randomised study of patients with endometrial polyps.
Blood loss during menstruation is documented with the help of a standardized form (PBAC). The patients are randomized to hysteroscopic resection of the endometrial polyp or 6 months of observation. A new registration of blood loss during menstruation is performed by patients in both groups. In the intervention group, a new gynaecological examination 6 months after the resection documents the presence of residual polyp or symptoms. The other group is examined again after 6 months of observation. Symptoms and findings with the second examination are compared with symptoms and findings at the first examination, any changes are documented and the final outcome in the to groups are compared.
Study Part 3: The occurrence and natural history of asymptomatic endometrial polyps in perimenopausal women. A prospective controlled study.
Registration of blood loss during menstruation is documented with the help of a standardized form (PBAC) and gynaecological examination including SIS of 1000 randomly selected women in the age group 45-50. Where endometrial polyps are identified, we document the size and number of polyps and an endometrial biopsy is taken. After including a woman with an endometrial polyp in the study, the next woman without endometrial polyp is recruited to the control group. After one year, blood loss during menstruation is registered again, and all women with endometrial polyps as well as the control group have a new examination including vaginal ultrasound, SIS and endometrial biopsy. Symptoms and findings are compared with symptoms and findings at the first examination and all changes are documented. If the woman has a persistent endometrial polyp when examined at 1 year, she is offered treatment with hysteroscopic polyp resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Study 1:
- Study 2:
- Study 3:
Key exclusion criteria (9 listed)
- Study 1: Earlier severe allergic reactions.
- Study 2:
- Study 3:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysteroscopic resection of endometrial polyps. (TCRP) | Procedure or surgery | – |
Primary outcome
Study part 1. Angiogenesis factor levels in endometrial biopsies in patients with endometrial polyps compared to patients with endometrial cancer
Resistance in the feeding vessel measured by doppler examination combined with intravenous (i.v.) contrast in patients with endometrial polyps and endometrial cancer
Study part 2. Change in pictorial blood loss assessment chart (PBAC) score in intervention compared to observation group
Study part 3. Change in PBAC score in women with endometrial polyps compared to control group
2 secondary outcomes
Associated factors for the development of endometrial polyps
Change in endometrial polyp size and symptoms after 6 and 12 months of observation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
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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.
Olav Istre, MD., PhD. principal investigator
Department og Gynaecology, Ullevaal University Hospital, Oslo, Norway.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopic resection of endometrial polyps. (TCRP) in people with Endometrial Polyp and Endometrial Cancer, run by Ullevaal University Hospital at 1 site in Norway.
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 9 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: finished, as of the sponsor's last update on 6 Jul 2011. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study part 1. Angiogenesis factor levels in endometrial biopsies in patients with endometrial polyps compared to patients with endometrial cancer. The study lists 4 primary outcomes in all. 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 6 Jul 2011.