COVID-GYN: Impact of the COVID-19 Pandemic in Gynecological Oncology

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT04351139
• Collaborator: (none)
• Enrollment: 205
• Locations: 3
• Actual Duration (Months): 6.8
• Patients Per Site: 68.3
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Cancer; Breast Neoplasm Female; Uterine Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms	Other: modification of the planned therapeutic management

Study Design

• Study Type: Observational
• Actual Enrollment: 205 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Official Title: Impact of the COVID-19 Pandemic on Changes in Therapeutic Strategies in Gynecological Oncology
• Actual Study Start Date: May 6, 2020
• Actual Primary Completion Date: Nov 30, 2020
• Actual Study Completion Date: Nov 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
gynecological cancer Patients over 18 with gynecological cancer (breast cancer, uterus, ovary, cervix, vagina or vulva cancer) and whose therapeutic management was planned during the period of COVID-19 pandemic during 2020	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
control group Patients over 18 with gynecological cancer (breast, uterus, ovary, cervix, vagina or vulva cancer) and whose therapeutic management was planned outside the period of COVID-19 pandemic, on the end of the year 2019	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

Outcome Measures

Primary Outcome Measures

1. percentage of patients with a change in the planned therapeutic management (surgery, chemotherapy, radiotherapy, hormone therapy) [Day O]

   modification of the planned therapeutic management

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Gynécologie, HFME, Hospices Civils de Lyon	Bron		France	69500
2	Service de Gynécologie, Croix-Rousse, Hospices Civils de Lyon	Lyon		France	69004
3	Service Gynécologie, CHLS, Hospices Civils de Lyon	Pierre-Bénite		France	69310

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

• Principal Investigator: Géry LAMBLIN, Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT04351139
• Other Study ID Numbers: 69HCL20_0346; 2020-A01036-33
• First Posted: Apr 17, 2020
• Last Update Posted: Jan 19, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospices Civils de Lyon: Gynecologic Cancer; COVID-19
• Additional relevant MeSH terms: COVID-19; Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Uterine Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms

Study Results

No Results Posted as of Jan 19, 2021