NCT05364905

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

May 9, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2022

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

April 29, 2022

Last Update Submit

September 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical, biological and treatment characteristics

    Description of the data

    up to 3 years

Secondary Outcomes (2)

  • Progession Free Survival real world (rwPFS)

    through study completion, an average of 1 year

  • Overall Survival (OS)

    through study completion, an average of 1 year

Study Arms (2)

Cohort 1

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

Drug: Chemotherapy

Cohort 2

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

Drug: Chemotherapy

Interventions

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 1Cohort 2

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population musy respect all the inclusion and exclusion criteria.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Centre Hospitalier Victor Dupouy

Argenteuil, 95100, France

Location

Sainte-Catherine Institut du Cancer Avignon-Provence

Avignon, 84918, France

Location

CHRU Besançon - Hôpital Jean Minjoz

Besançon, 25000, France

Location

Guillaume BABIN

Bordeaux, 33000, France

Location

Hôpital Morvan CHRU de Brest

Brest, 29200, France

Location

Centre d'Oncologie et de Radiothérapie 37

Chambray-lès-Tours, 37175, France

Location

Hôpital Louis Mourier

Colombes, 92700, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, 21079, France

Location

CHU de Dijon

Dijon, 21000, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Léon Bérard

Lyon, 69737, France

Location

ICL - Centre Alexis Vautrin

Nancy, 54000, France

Location

ORACLE - Centre d'Oncologie de Gentilly

Nancy, 54100, France

Location

Hôpital Privé du Confluent

Nantes, 44277, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Centre ONCOGARD - Institut de cancérologie du Gard

Nîmes, 30029, France

Location

CHR Orléans

Orléans, 45100, France

Location

Institut Curie

Paris, 75005, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Groupe Hospitalier Diaconesses - Croix Saint-Simon

Paris, 75020, France

Location

Centre CARIO - HPCA

Plérin, 22190, France

Location

CHU de Poitiers - Hôpital de la Milétrie

Poitiers, 86021, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

ICO - Centre René Gauducheau

Saint-Herblain, 44805, France

Location

ICANS - Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

Location

CHU Tours - Hôpital Bretonneau

Tours, 37044, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

NeoplasmsEndometrial NeoplasmsRecurrenceNeoplasm Metastasis

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic Processes

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2022

First Posted

May 6, 2022

Study Start

May 9, 2022

Primary Completion

November 22, 2022

Study Completion

November 22, 2022

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations