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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04351139
Other study ID # 69HCL20_0346
Secondary ID 2020-A01036-33
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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