Endometrial CancerNIECENCT05737797
Non-Invasive Diagnosis of Endometrial Cancer
A study testing cervical cytology during surgery. in people with Endometrial Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The study aims to determine whether next generation sequencing and microsatellite analysis of cervical cytology is sensitive for the detection of endometrial carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- cervical cytology during surgery.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2023to 10 Oct 2024
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endometrial cancer requiring hysterectomy
- Patient covered by French social Security
- Patient capable of giving written informed consent
Who cannot join
- Chemotherapy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Medical genetics department
Paris
Patrick BENISIGLIO, MD PhD, + 33 1 42 17 76 59, patrick.benusiglio@aphp.fr
Clémence EVREVIN, MD, + 33 1 42 17 76 59, Clemence.evrevin@aphp.fr
About this study
The study aims to determine whether next generation sequencing and microsatellite analysis of cervical cytology is sensitive for the detection of endometrial carcinoma.
Read the detailed description
Definitive diagnosis of endometrial cancer relies on endometrial biopsy, in addition to imaging. Biopsy is however invasive and often painful, and its sensitivity in only moderate. Cervical cytology could be an alternative. This is a proof-of-concept study. The investigators will carry out next generation sequencing of cervical cytology in patients with confirmed endometrial carcinoma, in order to determine whether activating variants are identified. About 15% of endometrial carcinomas are microsatellite instable (MSI). The investigators will therefore also carry out MSI analysis using MSICare in the subset of cases with MMR-deficient cancer.
- Conditions
- Endometrial Cancer
- Being tested
- cervical cytology during surgery.
- Keywords
- Endometrial cancer, Next-generation sequencing, Screening, Microsatellite instability
- Medical subject headings
- Endometrial Neoplasms, Microsatellite Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical cytology during surgery.Procedure or surgery
Cervical cytology will be performed by the surgeon in the operating theatre before hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| Endometrial cancer patients | Experimental | Endometrial cancer patients Cervical cytology during surgical intervention. Receives: Procedure: cervical cytology during surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activating variants and MSI via cytology
proportion of cases in whom genetic activating variants and microsatellite instability are detected by cytology
Measured: 16 months
Secondary outcomes (5)
Type of variants
Variant details
Measured: 16 months
Number of variants
Variant details
Measured: 16 months
Frequency of variants
Variant details
Measured: 16 months
Comparison with the proportion of variants seen on the pathological
Tumoral correlation
Measured: 16 months
Comparison with the proportion of microsatellite instability detected on the pathological specimen.
Tumoral correlation
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start3 Mar 2023
- Primary completion10 Oct 2024 (estimated)
- Study completion10 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737797
- Sponsor's protocol ID
- APHP221027
- Acronym
- NIECE
- Status last verified
- Feb 2024
- First submitted
- 26 Dec 2022
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Diagnosis of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT05737797
- Acronym / sponsor ID
- NIECE / APHP221027
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial cancer, Next-generation sequencing, Screening, Microsatellite instability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 Oct 2024 (estimated)
- First posted
- 21 Feb 2023 (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 study aims to determine whether next generation sequencing and microsatellite analysis of cervical cytology is sensitive for the detection of endometrial carcinoma.
Detailed description
Definitive diagnosis of endometrial cancer relies on endometrial biopsy, in addition to imaging. Biopsy is however invasive and often painful, and its sensitivity in only moderate. Cervical cytology could be an alternative. This is a proof-of-concept study. The investigators will carry out next generation sequencing of cervical cytology in patients with confirmed endometrial carcinoma, in order to determine whether activating variants are identified. About 15% of endometrial carcinomas are microsatellite instable (MSI). The investigators will therefore also carry out MSI analysis using MSICare in the subset of cases with MMR-deficient cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometrial cancer patients | Experimental | Procedure: cervical cytology during surgery.Endometrial cancer patients Cervical cytology during surgical intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Endometrial cancer requiring hysterectomy
- Patient covered by French social Security
- Patient capable of giving written informed consent
Key exclusion criteria (1 listed)
- Chemotherapy
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 |
|---|---|---|
| cervical cytology during surgery.Cervical cytology will be performed by the surgeon in the operating theatre before hysterectomy. | Procedure or surgery | Endometrial cancer patients |
Primary outcome
Activating variants and MSI via cytology
Time frame: 16 months
proportion of cases in whom genetic activating variants and microsatellite instability are detected by cytology
5 secondary outcomes
Type of variants
Time frame: 16 months
Number of variants
Time frame: 16 months
Frequency of variants
Time frame: 16 months
Comparison with the proportion of variants seen on the pathological
Time frame: 16 months
Comparison with the proportion of microsatellite instability detected on the pathological specimen.
Time frame: 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical cytology during surgery. in people with Endometrial Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 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 France. 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 Patrick BENUSIGLIO, MD PhD (+ 33 1 42 17 76 59, patrick.benusiglio@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activating variants and MSI via cytology (time frame: 16 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 22 Feb 2024.