Impact of the COVID-19 Pandemic in Gynecological Oncology

Gynecologic Cancer Clinical Trial

— COVID-GYN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351139
• Other study ID #: 69HCL20_0346
• Secondary ID: 2020-A01036-33
• Status: Completed
• Start date: May 6, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Gynecologic Cancer
• Neoplasms
• Ovarian Neoplasms
• Uterine Cervical Neoplasms
• Uterine Neoplasms
• Vaginal Neoplasms
• Vulvar Neoplasms

Intervention

Other:
• modification of the planned therapeutic management
to evaluate the changes in therapeutic management, during the COVID-19 pandemic, of patients suffering from gynecological cancers

Locations

Country	Name	City	State
France	Service de Gynécologie, HFME, Hospices Civils de Lyon	Bron
France	Service de Gynécologie, Croix-Rousse, Hospices Civils de Lyon	Lyon
France	Service Gynécologie, CHLS, Hospices Civils de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients with a change in the planned therapeutic management (surgery, chemotherapy, radiotherapy, hormone therapy)	modification of the planned therapeutic management	Day O