Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma

NCT ID: NCT05364905

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-09

Study Completion Date

2022-11-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a national observational retrospective multi-site chart review study of patients with advanced, recurrent or metastatic endometrial carcinoma.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oncology Endometrial Cancer Advanced Cancer Recurrent Cancer Metastatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

Patients in first line treatment (first chemotherapy for advanced, recurrent or metastatic endometrial cancer) in 2019

Chemotherapy

Intervention Type DRUG

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.

Cohort 2

Patients in second line treatment (after one prior systemic chemotherapy) in 2019

Chemotherapy

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chemotherapy

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adult women ≥ 18 years at index date.
2. 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.
3. Index date should represent at least the first\* or second line\*\* chemotherapy systemic treatment and occur between, 1, January 2019 and 31, December 2019.
4. do not express refusal to her personal data processing or did not express her refusal for deceased patients.

Exclusion Criteria

1. No clinical records for tumor imaging or administration of anti-cancer therapy.
2. 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.
3. 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).
4. Patient did not receive chemotherapy systemic treatment.
5. Patient undergo treatment by pembrolizumab or another immunotherapy in first line (cohort 1) or second line (cohort 2) during the eligibity (inclusion) period.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

ARCAGY/ GINECO GROUP

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Victor Dupouy

Argenteuil, , France

Site Status

Sainte-Catherine Institut du Cancer Avignon-Provence

Avignon, , France

Site Status

CHRU Besançon - Hôpital Jean Minjoz

Besançon, , France

Site Status

Guillaume BABIN

Bordeaux, , France

Site Status

Hôpital Morvan CHRU de Brest

Brest, , France

Site Status

Centre d'Oncologie et de Radiothérapie 37

Chambray-lès-Tours, , France

Site Status

Hôpital Louis Mourier

Colombes, , France

Site Status

Centre Hospitalier Intercommunal de Créteil

Créteil, , France

Site Status

CHU de Dijon

Dijon, , France

Site Status

Centre Georges François Leclerc

Dijon, , France

Site Status

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

ICL - Centre Alexis Vautrin

Nancy, , France

Site Status

ORACLE - Centre d'Oncologie de Gentilly

Nancy, , France

Site Status

Hôpital Privé du Confluent

Nantes, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

Centre ONCOGARD - Institut de cancérologie du Gard

Nîmes, , France

Site Status

CHR Orléans

Orléans, , France

Site Status

Institut Curie

Paris, , France

Site Status

Hôpital Cochin

Paris, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

Groupe Hospitalier Diaconesses - Croix Saint-Simon

Paris, , France

Site Status

Centre CARIO - HPCA

Plérin, , France

Site Status

CHU de Poitiers - Hôpital de la Milétrie

Poitiers, , France

Site Status

Centre Eugène Marquis

Rennes, , France

Site Status

ICO - Centre René Gauducheau

Saint-Herblain, , France

Site Status

ICANS - Institut de cancérologie Strasbourg Europe

Strasbourg, , France

Site Status

CHU Tours - Hôpital Bretonneau

Tours, , France

Site Status

Gustave Roussy

Villejuif, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GINECO-EN106

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sentinel Node Biopsy in Endometrial Cancer
NCT04073706 RECRUITING PHASE3