Impact of the COVID-19 Pandemic in Gynecological Oncology

The current infection with the Coronavirus SARS-CoV-2 (COVID-19) is an exceptional health situation which requires an adaptation of our management practices in gynecological oncology. Data from the literature suggest that infection with Coronavirus is serious in subjects with cancer with a risk of severe form 5 times higher than that of the population without cancer and a risk of death multiplied by 8. In addition, the risk of infection would be 3 times greater in case of cancer. Faced with the COVID-19 epidemic, the investigator must organize themselves to ensure continuity in the treatment of patients with gynecological cancer but also adapt our practices in the management (CPR, teleconsultation, adaptation of treatment or even postponement of treatment). The objective of the High Council of Public Health is to be able to ensure adequate oncological care avoiding any potential loss of chance concerning the care of cancer: people affected must, despite the pandemic, have care allowing the same level of curability (localized cancers) or the same life expectancy (advanced cancers). This must be done by limiting as much as possible the impact on the organization of the service, the organization of patient follow-up and the psychological impact that these possible modifications could have. The hypotheses of our study are that the exceptional health situation linked to this pandemic leads to a change in the care of patients with gynecological cancer associated with a psychological impact and increased anxiety of patients during their care. Despite the extent of the pandemic, very little existing data makes it possible to define recommendations with a sufficient level of evidence.

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Key information

Conditions

Gynecologic Cancer Adnexal Diseases Breast Neoplasm Female COVID-19 Coronaviridae Infections Coronavirus Infections Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Infections Lung Diseases Neoplasms Neoplasms by Site Nidovirales Infections Ovarian Diseases Ovarian Neoplasms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Diseases Vaginal Neoplasms Virus Diseases Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Service de Gynécologie, HFME, Hospices Civils de Lyon, Bron, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

women over 18
gynecological cancer (breast cancer, uterus, ovary, cervix, vagina or vulva cancer)
therapeutic management planned during quarantine
person having expressed his non-opposition

Inclusion criteria

of control group :

women over 18
gynecological cancer (breast, uterus, ovary, cervix, vagina or vulva cancer)
therapeutic management planned on the end of the year 2019
person having expressed his non-opposition

Exclusion criteria

inability to understand the information given
person deprived of liberty,
person under guardianship.

Treatment and study plan

modification of the planned therapeutic management

Other

to evaluate the changes in therapeutic management, during the COVID-19 pandemic, of patients suffering from gynecological cancers

Primary outcomes

percentage of patients with a change in the planned therapeutic management (surgery, chemotherapy, radiotherapy, hormone therapy)

Time frame: Day O

modification of the planned therapeutic management

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Impact of the COVID-19 Pandemic on Changes in Therapeutic Strategies in Gynecological Oncology

Acronym: COVID-GYN

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Apr 17, 2020
Registry last updated: Jan 19, 2021

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.

Published trials that share one or more normalized conditions with this study.

Completed