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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01036-33 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Inclusion Criteria of control group :
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Géry LAMBLIN | Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Gynécologie, HFME, Hospices Civils de Lyon | Bron | 69500 | France | |||
| Service de Gynécologie, Croix-Rousse, Hospices Civils de Lyon |
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| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D010051 | Ovarian Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D014846 | Vulvar Neoplasms |
| D014625 | Vaginal Neoplasms |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Lyon |
| 69004 |
| France |
| Service Gynécologie, CHLS, Hospices Civils de Lyon | Pierre-Bénite | 69310 | France |
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002577 | Uterine Cervical Diseases |
| D014845 | Vulvar Diseases |
| D014623 | Vaginal Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |