Endometrial Hyperplasia and Endometrial CancersNCT03338985
Role of Senescence in the Development of Endometrial Cancer
A study testing Genetic analysis in people with Endometrial Hyperplasia and Endometrial Cancers, run by CHU de Reims at 1 site in France.
Trial summary
Several molecular studies showed chromosomal alterations in patients with endometrial cancer, with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of interest have been identified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Hyperplasia and Endometrial Cancers
- What is being tested?
- Genetic analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2017to 16 Apr 2020
- 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
- patient with endometrial hyperplasia or endometrial cancer
- patient consenting to participate to the study
- patient enrolled in the national healthcare insurance program
- patient older than 18 years
Who cannot join
- patient with neoadjuvant chemotherapy or radiotherapy prior to surgery
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Emilie RAIMOND, eraimond@chu-reims.fr
About this study
Several molecular studies showed chromosomal alterations in patients with endometrial cancer, with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of interest have been identified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...).
A study has already been carried out at the Reims University Hospital with inclusion of patients with endometrial cancer and patients with endometrial hyperplasia. It identified specific alterations of nosologic continuum of pathology and characterize areas of interest on the genome.
Read the detailed description
make a pangenomic investigation of genetic abnormalities in atypical endometrial hyperplasia and endometrial cancers.
- Being tested
- Genetic analysis
- 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.
Genetic analysisGenetic
Genetic analysis of the samples taken during the surgery (hysterectomy or curettage resection) using CGH array technique.
| Study group | Role | What they receive |
|---|---|---|
| Group "cases patients" | Experimental | patients with endometrial hyperplasia or endometrial cancers Receives: Genetic: Genetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic imbalances
Genetic aberrations detected by comparative genomic hybridization (CGH arry)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start16 Oct 2017
- Primary completion16 Oct 2019 (estimated)
- Study completion16 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Hyperplasia and Endometrial CancersStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338985
- Sponsor's protocol ID
- PA17002
- Status last verified
- Jan 2018
- First submitted
- 8 Nov 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Senescence in the Development of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03338985
- Acronym / sponsor ID
- PA17002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 16 Oct 2019 (estimated)
- Study completion
- 16 Apr 2020 (estimated)
- First posted
- 9 Nov 2017 (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.
Several molecular studies showed chromosomal alterations in patients with endometrial cancer, with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of interest have been identified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...).
A study has already been carried out at the Reims University Hospital with inclusion of patients with endometrial cancer and patients with endometrial hyperplasia. It identified specific alterations of nosologic continuum of pathology and characterize areas of interest on the genome.
Detailed description
make a pangenomic investigation of genetic abnormalities in atypical endometrial hyperplasia and endometrial cancers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group "cases patients" | Experimental | Genetic: Genetic analysispatients with endometrial hyperplasia or endometrial cancers |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient with endometrial hyperplasia or endometrial cancer
- patient consenting to participate to the study
- patient enrolled in the national healthcare insurance program
- patient older than 18 years
Key exclusion criteria (1 listed)
- patient with neoadjuvant chemotherapy or radiotherapy prior to surgery
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 |
|---|---|---|
| Genetic analysisGenetic analysis of the samples taken during the surgery (hysterectomy or curettage resection) using CGH array technique. | Genetic | Group "cases patients" |
Primary outcome
Genetic imbalances
Time frame: Day 0
Genetic aberrations detected by comparative genomic hybridization (CGH arry)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
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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 Genetic analysis in people with Endometrial Hyperplasia and Endometrial Cancers, run by CHU de Reims 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 4 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 5 Jan 2018. 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 Emilie RAIMOND (0326789598, eraimond@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic imbalances (time frame: Day 0). 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 5 Jan 2018.