Gynecologic CancerCOVID-GYNNCT04351139
Impact of the COVID-19 Pandemic in Gynecological Oncology
An observational study of Gynecologic Cancer and Breast Neoplasm Female, run by Hospices Civils de Lyon at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Breast Neoplasm Female, Uterine Neoplasms
- What is being tested?
- modification of the planned therapeutic management
- How many people
- 205 participants
- Where
- 3 sitesFrance
- Study dates
- 6 May 2020to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- inability to understand the information given
- person deprived of liberty,
- person under guardianship.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de Gynécologie, HFME, Hospices Civils de Lyon
Bron, 69500
Service de Gynécologie, Croix-Rousse, Hospices Civils de Lyon
Lyon, 69004
Service Gynécologie, CHLS, Hospices Civils de Lyon
Pierre-Bénite, 69310
About this study
Official title: Impact of the COVID-19 Pandemic on Changes in Therapeutic Strategies in Gynecological Oncology
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
- Being tested
- modification of the planned therapeutic management
- Keywords
- Gynecologic Cancer, COVID-19
- Medical subject headings
- Uterine Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modification of the planned therapeutic managementOther
to evaluate the changes in therapeutic management, during the COVID-19 pandemic, of patients suffering from gynecological cancers
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: modification of the planned therapeutic management |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with a change in the planned therapeutic management (surgery, chemotherapy, radiotherapy, hormone therapy)
modification of the planned therapeutic management
Measured: Day O
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start6 May 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Géry LAMBLIN, Principal investigator, Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351139
- Sponsor's protocol ID
- 69HCL20_0346
- Other IDs
- 2020-A01036-33
- Acronym
- COVID-GYN
- Status last verified
- Jan 2021
- First submitted
- 15 Apr 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the COVID-19 Pandemic on Changes in Therapeutic Strategies in Gynecological Oncology
- ClinicalTrials.gov ID
- NCT04351139
- Acronym / sponsor ID
- COVID-GYN / 69HCL20_0346
- Conditions
- Gynecologic Cancer, Breast Neoplasm Female, Uterine Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms
- Keywords
- Gynecologic Cancer, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gynecological cancer | – | Other: modification of the planned therapeutic managementPatients 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 | – | Other: modification of the planned therapeutic managementPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- inability to understand the information given
- person deprived of liberty,
- person under guardianship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modification of the planned therapeutic managementto evaluate the changes in therapeutic management, during the COVID-19 pandemic, of patients suffering from gynecological cancers | Other | control group, gynecological cancer |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
Related trials for Gynecologic Cancer
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Enrolling by invitation
Peer Ambassador in Gyn Onc Trials
Ovarian Cancer
RecruitingObservational study
Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study
Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Géry LAMBLIN principal investigator
Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer and Breast Neoplasm Female, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with a change in the planned therapeutic management (surgery, chemotherapy, radiotherapy, hormone therapy) (time frame: Day O). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.