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OpenTrials
Completed

NCT Number: NCT05364905

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Chemotherapy

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.

Primary outcomes

  1. Clinical, biological and treatment characteristics

    Time frame: up to 3 years

    Description of the data

Secondary outcomes

  1. Progession Free Survival real world (rwPFS)

    Time frame: through study completion, an average of 1 year

    From the date of initiation of the treatment in the corresponding line to the date of progression or death

  2. Overall Survival (OS)

    Time frame: through study completion, an average of 1 year

    From the date of initiation of the treatment in the corresponding line to the date of death

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma: A Retrospective Study

Acronym: ENDOVIE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 6, 2022
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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