Clinical trial NCT05364905: Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma
Official title: Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncology
Endometrial Cancer
Advanced Cancer
Recurrent Cancer
Metastatic Cancer
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-05-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population musy respect all the inclusion and exclusion criteria.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical, biological and treatment characteristics
timeFrame: up to 3 years
Secondary outcomes:
measure: Progession Free Survival real world (rwPFS)
timeFrame: through study completion, an average of 1 year
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Avignon
country: France
facility: Sainte-Catherine Institut du Cancer Avignon-Provence
city: Besançon
country: France
facility: CHRU Besançon - Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: Guillaume BABIN
city: Brest
country: France
facility: Hôpital Morvan CHRU de Brest
city: Chambray-lès-Tours
country: France
facility: Centre d'Oncologie et de Radiothérapie 37
city: Colombes
country: France
facility: Hôpital Louis Mourier
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Dijon
country: France
facility: CHU de Dijon
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Nancy
country: France
facility: ICL - Centre Alexis Vautrin
city: Nancy
country: France
facility: ORACLE - Centre d'Oncologie de Gentilly
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nîmes
country: France
facility: Centre ONCOGARD - Institut de cancérologie du Gard
city: Orléans
country: France
facility: CHR Orléans
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses - Croix Saint-Simon
city: Plérin
country: France
facility: Centre CARIO - HPCA
city: Poitiers
country: France
facility: CHU de Poitiers - Hôpital de la Milétrie
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-Herblain
country: France
facility: ICO - Centre René Gauducheau
city: Strasbourg
country: France
facility: ICANS - Institut de cancérologie Strasbourg Europe
city: Tours
country: France
facility: CHU Tours - Hôpital Bretonneau
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
References: