Impact of the COVID-19 Pandemic in Gynecological Oncology

NCT04351139 | Completed

• 2 other identifiers: 69HCL20_03462020-A01036-33
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Gynecologic Cancer; COVID-19

Outcome Measures

Primary Outcomes (1)

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

  modification of the planned therapeutic management

  Day O

Study Arms (2)

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

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

Interventions

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

control group; gynecological cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 with gynecological cancer (non-metastatic breast cancer, uterus, ovary, cervix, vagina or vulva cancer) and whose therapeutic management was planned during the period of COVID-19 pandemic quarantine. 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.

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Service de Gynécologie, HFME, Hospices Civils de Lyon

Bron, 69500, France

Location

Service de Gynécologie, Croix-Rousse, Hospices Civils de Lyon

Lyon, 69004, France

Location

Service Gynécologie, CHLS, Hospices Civils de Lyon

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Uterine Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Géry LAMBLIN

  Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 17, 2020
• Study Start: May 6, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

FR (3)