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Impact of the COVID-19 Pandemic in Gynecological Oncology (COVID-GYN)

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ClinicalTrials.gov Identifier: NCT04351139
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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
Gynecologic Cancer Breast Neoplasm Female Uterine Neoplasms Ovarian Neoplasms Uterine Cervical Neoplasms Vulvar Neoplasms Vaginal Neoplasms Other: modification of the planned therapeutic management

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Study Type : Observational
Estimated Enrollment : 400 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
Estimated Primary Completion Date : November 6, 2020
Estimated Study Completion Date : November 6, 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351139


Contacts
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Contact: Géry LAMBLIN, MD 472 35 58 71 ext +33 gery.lamblin@chu-lyon.fr

Locations
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France
Service de Gynécologie, HFME, Hospices Civils de Lyon Recruiting
Bron, France, 69500
Contact: Géry LAMBLIN, MD       gery.lamblin@chu-lyon.fr   
Principal Investigator: Géry LAMBLIN, MD         
Service de Gynécologie, Croix-Rousse, Hospices Civils de Lyon Recruiting
Lyon, France, 69004
Contact: Gil Dubernard, MD       Gil.dubernard@chu-lyon.fr   
Principal Investigator: Gil Dubernard, MD         
Sub-Investigator: Marion Cortet, MD         
Service Gynécologie, CHLS, Hospices Civils de Lyon Recruiting
Pierre-Bénite, France, 69310
Contact: François Golfier, MD         
Principal Investigator: François Golfier, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Géry LAMBLIN Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04351139    
Other Study ID Numbers: 69HCL20_0346
2020-A01036-33 ( Other Identifier: ID-RCB )
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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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:
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Neoplasms
Breast Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Cervical Diseases
Uterine Diseases
Vulvar Diseases
Vaginal Diseases