OncologyENDOVIENCT05364905
Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma
An observational study of Oncology and Endometrial Cancer, run by ARCAGY/ GINECO GROUP at 30 sites in France.
Trial summary
This is a national observational retrospective multi-site chart review study of patients with advanced, recurrent or metastatic endometrial carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Oncology, Endometrial Cancer, Advanced Cancer
- What is being tested?
- Chemotherapy
- How many people
- 200 participants
- Where
- 30 sitesFrance
- Study dates
- 9 May 2022to 22 Nov 2022
- 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 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population musy respect all the inclusion and exclusion criteria.
Who may be able to join
- Adult women ≥ 18 years at index date.
- Documented diagnosis of advanced recurrent or metastatic endometrial cancer not eligible to primary complete surgery. Patients with interval surgery after primary CT may be eligible.
- Index date should represent at least the first* or second line** chemotherapy systemic treatment and occur between, 1, January 2019 and 31, December 2019.
- do not express refusal to her personal data processing or did not express her refusal for deceased patients.
Who cannot join
- No clinical records for tumor imaging or administration of anti-cancer therapy.
- Patients with active malignancy other than EC cancer which contribute significantly to the clinical impairment of the patient during the study period, according to investigator opinion.
- Patients lost to follow-up, defined as patients whose last follow-up information occurs less than two years after index date (unless the patient is deceased).
- Patient did not receive chemotherapy systemic treatment.
- Patient undergo treatment by pembrolizumab or another immunotherapy in first line (cohort 1) or second line (cohort 2) during the eligibity (inclusion) period.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
France30 sites
Centre Hospitalier Victor Dupouy
Argenteuil, 95100
Sainte-Catherine Institut du Cancer Avignon-Provence
Avignon, 84918
CHRU Besançon - Hôpital Jean Minjoz
Besançon, 25000
Guillaume BABIN
Bordeaux, 33000
Hôpital Morvan CHRU de Brest
Brest, 29200
Centre d'Oncologie et de Radiothérapie 37
Chambray-lès-Tours, 37175
Hôpital Louis Mourier
Colombes, 92700
Centre Hospitalier Intercommunal de Créteil
Créteil, 21079
CHU de Dijon
Dijon, 21000
Centre Georges François Leclerc
Dijon, 21079
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38028
Centre Oscar Lambret
Lille, 59020
Centre Léon Bérard
Lyon, 69737
ICL - Centre Alexis Vautrin
Nancy, 54000
ORACLE - Centre d'Oncologie de Gentilly
Nancy, 54100
Hôpital Privé du Confluent
Nantes, 44277
Centre Antoine Lacassagne
Nice, 06189
Centre ONCOGARD - Institut de cancérologie du Gard
Nîmes, 30029
CHR Orléans
Orléans, 45100
Institut Curie
Paris, 75005
Hôpital Cochin
Paris, 75014
Hôpital Européen Georges Pompidou
Paris, 75015
Groupe Hospitalier Diaconesses - Croix Saint-Simon
Paris, 75020
Centre CARIO - HPCA
Plérin, 22190
CHU de Poitiers - Hôpital de la Milétrie
Poitiers, 86021
Centre Eugène Marquis
Rennes, 35042
ICO - Centre René Gauducheau
Saint-Herblain, 44805
ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, 67033
CHU Tours - Hôpital Bretonneau
Tours, 37044
Gustave Roussy
Villejuif, 94805
About this study
Official title: Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma: A Retrospective Study
This is a national observational retrospective multi-site chart review study of patients with advanced, recurrent or metastatic endometrial carcinoma.
- Being tested
- Chemotherapy
- Medical subject headings
- Neoplasms, Endometrial Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Patients with confirmed advanced, recurrent or metastatic endometrial cancer, treated by chemotherapy in real life-setting, between 1st January 2019 to 31rd December March 2019, in first or second line of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients in first line treatment (first chemotherapy for advanced, recurrent or metastatic endometrial cancer) in 2019 Receives: Drug: Chemotherapy | |
| Cohort 2 | Patients in second line treatment (after one prior systemic chemotherapy) in 2019 Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical, biological and treatment characteristics
Description of the data
Measured: up to 3 years
Secondary outcomes (2)
Progession Free Survival real world (rwPFS)
From the date of initiation of the treatment in the corresponding line to the date of progression or death
Measured: through study completion, an average of 1 year
Overall Survival (OS)
From the date of initiation of the treatment in the corresponding line to the date of death
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start9 May 2022
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364905
- Sponsor's protocol ID
- GINECO-EN106
- Acronym
- ENDOVIE
- Status last verified
- Sep 2023
- First submitted
- 29 Apr 2022
- Last updated
- 6 Sep 2023
- 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 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma: A Retrospective Study
- ClinicalTrials.gov ID
- NCT05364905
- Acronym / sponsor ID
- ENDOVIE / GINECO-EN106
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 9 May 2022 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 6 May 2022 (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 is a national observational retrospective multi-site chart review study of patients with advanced, recurrent or metastatic endometrial carcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: ChemotherapyPatients in first line treatment (first chemotherapy for advanced, recurrent or metastatic endometrial cancer) in 2019 |
| Cohort 2 | – | Drug: ChemotherapyPatients in second line treatment (after one prior systemic chemotherapy) in 2019 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population musy respect all the inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- Adult women ≥ 18 years at index date.
- Documented diagnosis of advanced recurrent or metastatic endometrial cancer not eligible to primary complete surgery. Patients with interval surgery after primary CT may be eligible.
- Index date should represent at least the first* or second line** chemotherapy systemic treatment and occur between, 1, January 2019 and 31, December 2019.
- do not express refusal to her personal data processing or did not express her refusal for deceased patients.
Key exclusion criteria (5 listed)
- No clinical records for tumor imaging or administration of anti-cancer therapy.
- Patients with active malignancy other than EC cancer which contribute significantly to the clinical impairment of the patient during the study period, according to investigator opinion.
- Patients lost to follow-up, defined as patients whose last follow-up information occurs less than two years after index date (unless the patient is deceased).
- Patient did not receive chemotherapy systemic treatment.
- Patient undergo treatment by pembrolizumab or another immunotherapy in first line (cohort 1) or second line (cohort 2) during the eligibity (inclusion) period.
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 |
|---|---|---|
| ChemotherapyPatients with confirmed advanced, recurrent or metastatic endometrial cancer, treated by chemotherapy in real life-setting, between 1st January 2019 to 31rd December March 2019, in first or second line of chemotherapy. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Clinical, biological and treatment characteristics
Time frame: up to 3 years
Description of the data
2 secondary outcomes
Progession Free Survival real world (rwPFS)
Time frame: through study completion, an average of 1 year
Overall Survival (OS)
Time frame: through study completion, an average of 1 year
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 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology and Endometrial Cancer, run by ARCAGY/ GINECO GROUP at 30 sites 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 5 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 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites 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?
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?
Clinical, biological and treatment characteristics (time frame: up to 3 years). 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 Sep 2023.