Endometrial HyperplasiaFETCHNCT04362046
Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia
A study testing Hysteroscopic uterine resection in people with Endometrial Hyperplasia and Endometrial Cancer, run by Vancouver Coastal Health Research Institute at 1 site in Canada.
Trial summary
This study protocol evaluates the use of hysteroscopic endomyometrial resection in women diagnosed with atypical endometrial hyperplasia or grade I endometrial cancer who have not responded to anti-hormone therapy. Patients in this study wish to preserve fertility. Read more about this study
- Who is it for?
- Ages 19 to 39 years, women only
- Conditions the study is for
- Endometrial Hyperplasia, Endometrial Cancer, Gynecologic Cancer
- What is being tested?
- Hysteroscopic uterine resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2020to Jul 2028
- Phase
- Interventional
- 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 19 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age less than 40 years
- Pathologist confirmed biopsy evidence of one of the following:
- Grade I endometrial endometrioid adrenocarcinoma (EC) with less than 1/3 of the endometrial surface involved.
- Atypical endometrial hyperplasia (AH)
- MRI demonstrating less than 1/3 myometrial invasion if the patient has EC
- Absence of significant surgical co-morbidities e.g. pulmonary hypertension, significant cardiac valvular disease, or contraindication to surgery.
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- Desire to preserve fertility
- Reasonable chance to conceive based on consultation with an infertility specialist
- Adequate dose and duration of progesterone therapy prior to enrolment:
- Adequate dose:
- Medroxyprogesterone acetate (Provera; 200mg/day)
- Megestrol acetate (Megace; 160mg/day)
- Adequate duration: 6 months
- Failure of progestin therapy defined as:
- Unsuccessful eradication of hyperplasia or cancer in the uterus
- Intolerance to the side effects
- Signed informed consent
Who cannot join
- Age 40 years and over
- Grade 2 or 3 endometrioid endometrial adenocarcinoma or non-endometrioid pathology
- Greater than 1/3 involvement of the endometrial surface in patients with Grade I EC
- Women who are not able to provide informed consent
- Women without pathologic confirmation of low-grade endometrioid carcinoma or AH
- Myometrial invasion on MRI greater than 1/3 total myometrial thickness.
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- MRI evidence of ovarian or adnexal involvement
- The diagnosis of another cancer or medical condition that would interfere with the assessment of the hysteroscopic surgery success rates.
- Significant underlying fertility impairment that would significantly interfere with the success rate of HR
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Janice Kwon, MD, 604-875-4268, janice.kwon@vch.ca
Neeraj Mehra, MD
About this study
Official title: Fertility Preservation Using Endomyometrial Resection for Atypical Hyperplasia and Low Grade, Stage 1A, Endometrial Cancer
This study protocol evaluates the use of hysteroscopic endomyometrial resection in women diagnosed with atypical endometrial hyperplasia or grade I endometrial cancer who have not responded to anti-hormone therapy. Patients in this study wish to preserve fertility.
Read the detailed description
Endometrial cancer (EC) is the most common gynecological cancer among Canadian women. This cancer often arises from a precursor lesion called atypical endometrial hyperplasia (AH). Hysterectomy is the most effective treatment for EC and AH. It is well recognized that EC may be diagnosed in younger women of child-bearing age. The diagnosis of EC or AH in these younger women is devastating as a hysterectomy is frequently required. Though some of these women respond to high-dose progestin treatment, the failure rate is high (60%), necessitating surgery. Recent case series show that some women with AH and early EC can be treated by resecting the precursor lesion of the early cancerous area in the uterus by hysteroscopy without the need for hysterectomy. The fertility-sparing approach is outlined in this research protocol.This is a multidisciplinary research project with input from gynaecologic oncology, general gynaecology, reproductive endocrinology and infertility, and pathology. Our hypothesis is that hysteroscopic resection (HR) is a safe and effective treatment for AH or EC in women who want to preserve their fertility and have not been successfully treated using progestin therapy. Patients will be closely monitored to ensure that this is a safe and effective treatment option.
- Being tested
- Hysteroscopic uterine resection
- Keywords
- Fertility preservation, Hysteroscopic uterine resection, High-dose progesterone
- Medical subject headings
- Endometrial Hyperplasia, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic uterine resectionProcedure or surgery
Hysteroscopic Resection will be evaluated as a fertility-sparing treatment for patients with early Endometrial Cancer or Endometrial Hyperplasia (atypical or persisting typical) who fail progestin therapy. Failure of progesterone therapy is defined as: (a) Unsuccessful eradication of hyperplasia or cancer in the uterus or (b) Intolerance to the side effects of th hormone therapy.
HR is a common gynecologic procedure that is offered to women for treatment of several benign gynecologic conditions. The conduct, risks, and complications of it are well-understood. In relation to this protocol, it is the indication for HR that constitutes the experimental intervention including the assessment of it's outcome. Patients deemed appropriate for hysteroscopic endomyometrial resection will be counselled on the nature of the procedure along with its risks and complications.
| Study group | Role | What they receive |
|---|---|---|
| Hysteroscopic uterine resection | Experimental | This is a prospective single-arm surgical intervention trial. Receives: Procedure: Hysteroscopic uterine resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conception rate of women attempting pregnancy
live births / women attempting pregnancy
Measured: 3 years post-resection
Overall conception rate
live births / all women participating in study, including those who failed hysteroscopic resection and have a hysterectomy
Measured: 3 years post-resection
Local disease control rate (short-term failure of hysteroscopic resection)
Patients with persisting atypical hyperplasia or Grade I endometrial cancer / patients treated with hysteroscopic resection
Measured: 3 months post-resection
Distant disease control rate (long-term failure of hysteroscopic resection)
patients developing distant recurrence / patients treated with hysteroscopic resection
Measured: 3 years post-resection
Secondary outcomes (1)
Complications/side-effects
The investigators will tabulate complications/side-effects of the procedure such as the rate of uterine perforation, uterine adhesion, procedure infection, and others.
Measured: 3 years post-resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start15 Nov 2020
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial HyperplasiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vancouver Coastal Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, Mark Carey, Vancouver Coastal Health Research Institute
- Investigators
- Mark Carey, MD, Principal investigator, Vancouver Coastal Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362046
- Sponsor's protocol ID
- H17-00780
- Acronym
- FETCH
- Status last verified
- Oct 2021
- First submitted
- 22 Apr 2020
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information in database/registry is anonymized. Inadvertent disclosure of the data poses no risk to patients.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Preservation Using Endomyometrial Resection for Atypical Hyperplasia and Low Grade, Stage 1A, Endometrial Cancer
- ClinicalTrials.gov ID
- NCT04362046
- Acronym / sponsor ID
- FETCH / H17-00780
- Keywords
- Fertility preservation, Hysteroscopic uterine resection, High-dose progesterone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vancouver Coastal Health Research InstituteUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 24 Apr 2020 (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.
This study protocol evaluates the use of hysteroscopic endomyometrial resection in women diagnosed with atypical endometrial hyperplasia or grade I endometrial cancer who have not responded to anti-hormone therapy. Patients in this study wish to preserve fertility.
Detailed description
Endometrial cancer (EC) is the most common gynecological cancer among Canadian women. This cancer often arises from a precursor lesion called atypical endometrial hyperplasia (AH). Hysterectomy is the most effective treatment for EC and AH. It is well recognized that EC may be diagnosed in younger women of child-bearing age. The diagnosis of EC or AH in these younger women is devastating as a hysterectomy is frequently required. Though some of these women respond to high-dose progestin treatment, the failure rate is high (60%), necessitating surgery. Recent case series show that some women with AH and early EC can be treated by resecting the precursor lesion of the early cancerous area in the uterus by hysteroscopy without the need for hysterectomy. The fertility-sparing approach is outlined in this research protocol.This is a multidisciplinary research project with input from gynaecologic oncology, general gynaecology, reproductive endocrinology and infertility, and pathology. Our hypothesis is that hysteroscopic resection (HR) is a safe and effective treatment for AH or EC in women who want to preserve their fertility and have not been successfully treated using progestin therapy. Patients will be closely monitored to ensure that this is a safe and effective treatment option.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hysteroscopic uterine resection | Experimental | Procedure: Hysteroscopic uterine resectionThis is a prospective single-arm surgical intervention trial. |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Age less than 40 years
- Pathologist confirmed biopsy evidence of one of the following:
- MRI demonstrating less than 1/3 myometrial invasion if the patient has EC
- Absence of significant surgical co-morbidities e.g. pulmonary hypertension, significant cardiac valvular disease, or contraindication to surgery.
- Desire to preserve fertility
Key exclusion criteria (9 listed)
- Age 40 years and over
- Grade 2 or 3 endometrioid endometrial adenocarcinoma or non-endometrioid pathology
- Greater than 1/3 involvement of the endometrial surface in patients with Grade I EC
- Women who are not able to provide informed consent
- Women without pathologic confirmation of low-grade endometrioid carcinoma or AH
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 uterine resectionHysteroscopic Resection will be evaluated as a fertility-sparing treatment for patients with early Endometrial Cancer or Endometrial Hyperplasia (atypical or persisting typical) who fail progestin therapy. Failure of progesterone therapy is defined as: (a) Unsuccessful eradication of hyperplasia or cancer in the uterus or (b) Intolerance to the side effects of th hormone therapy. HR is a common gynecologic procedure that is offered to women for treatment of several benign gynecologic conditions. The conduct, risks, and complications of it are well-understood. In relation to this protocol, it is the indication for HR that constitutes the experimental intervention including the assessment of it's outcome. Patients deemed appropriate for hysteroscopic endomyometrial resection will be counselled on the nature of the procedure along with its risks and complications. | Procedure or surgery | Hysteroscopic uterine resection |
Primary outcome
Conception rate of women attempting pregnancy
Time frame: 3 years post-resection
live births / women attempting pregnancy
Overall conception rate
Time frame: 3 years post-resection
live births / all women participating in study, including those who failed hysteroscopic resection and have a hysterectomy
Local disease control rate (short-term failure of hysteroscopic resection)
Time frame: 3 months post-resection
Patients with persisting atypical hyperplasia or Grade I endometrial cancer / patients treated with hysteroscopic resection
Distant disease control rate (long-term failure of hysteroscopic resection)
Time frame: 3 years post-resection
patients developing distant recurrence / patients treated with hysteroscopic resection
1 secondary outcome
Complications/side-effects
Time frame: 3 years post-resection
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 20 Oct 2021.
- Individual participant dataSharing planned: No. The information in database/registry is anonymized. Inadvertent disclosure of the data poses no risk to patients.
Related trials for Endometrial Hyperplasia
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Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
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Active, not recruitingPhase 2
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7
RecruitingObservational study
Liquid Biopsy-Based Early Screening for Endometrial Cancer in Regional Chinese Populations
Endometrial Cancer, Atypical Endometrial Hyperplasia
Not yet recruitingPhase 2
Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer
Endometrioid Endometrial Cancer, Atypical Endometrial Hyperplasia
RecruitingPhase 2
A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia
Endometrioid Endometrial Adenocarcinoma
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.
Mark Carey, MD principal investigator
Vancouver Coastal Health
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 uterine resection in people with Endometrial Hyperplasia and Endometrial Cancer, run by Vancouver Coastal Health Research Institute at 1 site in Canada.
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 17 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: looking for participants now, as of the sponsor's last update on 20 Oct 2021. 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 Canada. 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 Neeraj Mehra, MD (604-875-5508, neeraj.mehra@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conception rate of women attempting pregnancy (time frame: 3 years post-resection). 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 20 Oct 2021.