CancerCOCANCT04910633
Medical Treatment of Solid Tumors at the Lyon University Hospital Cancer Institute During the First Wave of COVID-19 in France: A Conservative Approach
An observational study of Cancer and Solid Tumor, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
An article to present how cancer patients were taken in charge at Lyon University Hospital Cancer Institute (France) during the first peak of the COVID-19 pandemic between March and May 2020 is under writing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor, Covid19
- What is being tested?
- COCA is an observational study based on retrospective data issued from patient medial file.
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2020to 22 Jan 2021
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a LUHCI cancer code created after 2015 and a LUHCI COVID-19 code created between March 2020 and May 2020.
Who may be able to join
- Patients with a LUHCI code created after 2015 and a LUHCI COVID-19 code created between March 2020 and May 2020.
Who cannot join
- Patients who did not allow the reuse of their medical file data for research related to COVID-19-
Trial locations and contacts
1 site in 1 country.
About this study
An article to present how cancer patients were taken in charge at Lyon University Hospital Cancer Institute (France) during the first peak of the COVID-19 pandemic between March and May 2020 is under writing.
It will present strategies that were set-up to avoid cross-contamination between patients and caregivers, patients treatment adaptation (timing, dosage,..) and how consultations, multidisciplinary team meetings, surgical procedures and clinical trials were impacted.
Part of this article will also illustrate the characteristics of patients with a solid tumor(s) that have been hospitalized during this timeframe for the COVID-19. How cancer type and stage affect Covid severity and mortality.will be described for a small sample of patients (44). These qualitative figures will be compared to literature current state of the art.
- Conditions
- Cancer, Solid Tumor, Covid19
- Being tested
- COCA is an observational study based on retrospective data issued from patient medial file.
- Keywords
- COVID-19, Cancer, Solid Tumor, Qualitative study, First pandemic wave
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COCA is an observational study based on retrospective data issued from patient medial file.Other
The following parameters will be collected from the medical files of the patients involved in this study:
- Age
- Gender
- Cancer type
- Cancer Stage
- Cancer Treatment
- COVID-19 severity (based on chest X-Ray damage. Low ≤25%, Middle: between 25-50%, High above 50%)
- Living Status
- Attribution of Mortality to COVID status
- Comorbidities
| Study group | Role | What they receive |
|---|---|---|
| Solid Tumor and COVID-19 | Patients with a solid tumor followed by an oncologist of Lyon University Hospital Cancer Institute (LUHCI) who have been hospitalized at LUHCI for the COVID-19 between March and May 2020 and who didn't oppose the reuse of their medical file data for research purpose. Receives: Other: COCA is an observational study based on retrospective data issued from patient medial file. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illustration of the repartition of COVID+ patient severity (Low/Medium/Severe status) depending on cancer nature, stage and patient age.
COVID-19 severity will be determined based on chest X-Ray damage as follow. Low severity : ≤25% of chest X-Ray damage, Middle severity: between 25-50% of chest X-Ray damage, High Severity : above 50% of chest X-Ray damage.
A graphic will then be drafted to present the relationship between Covid-19 severity depending on patient age, cancer nature, and cancer stage.
Measured: At the end of Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start2 Dec 2020
- Primary completion9 Dec 2020
- Study completion22 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 only
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910633
- Sponsor's protocol ID
- 69HCL21_0005
- Acronym
- COCA
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 2 Jun 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 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Treatment of Solid Tumors at the Lyon University Hospital Cancer Institute During the First Wave of COVID-19 in France: A Conservative Approach
- ClinicalTrials.gov ID
- NCT04910633
- Acronym / sponsor ID
- COCA / 69HCL21_0005
- Conditions
- Cancer, Solid Tumor, Covid19
- Keywords
- COVID-19, Cancer, Solid Tumor, Qualitative study, First pandemic wave
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 2 Jun 2021 (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.
An article to present how cancer patients were taken in charge at Lyon University Hospital Cancer Institute (France) during the first peak of the COVID-19 pandemic between March and May 2020 is under writing.
It will present strategies that were set-up to avoid cross-contamination between patients and caregivers, patients treatment adaptation (timing, dosage,..) and how consultations, multidisciplinary team meetings, surgical procedures and clinical trials were impacted.
Part of this article will also illustrate the characteristics of patients with a solid tumor(s) that have been hospitalized during this timeframe for the COVID-19. How cancer type and stage affect Covid severity and mortality.will be described for a small sample of patients (44). These qualitative figures will be compared to literature current state of the art.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solid Tumor and COVID-19 | – | Other: COCA is an observational study based on retrospective data issued from patient medial file.Patients with a solid tumor followed by an oncologist of Lyon University Hospital Cancer Institute (LUHCI) who have been hospitalized at LUHCI for the COVID-19 between March and May 2020 and who didn't oppose the reuse of their medical file data for research purpose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a LUHCI cancer code created after 2015 and a LUHCI COVID-19 code created between March 2020 and May 2020.
Key inclusion criteria (1 listed)
- Patients with a LUHCI code created after 2015 and a LUHCI COVID-19 code created between March 2020 and May 2020.
Key exclusion criteria (1 listed)
- Patients who did not allow the reuse of their medical file data for research related to COVID-19-
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 |
|---|---|---|
| COCA is an observational study based on retrospective data issued from patient medial file.The following parameters will be collected from the medical files of the patients involved in this study: * Age * Gender * Cancer type * Cancer Stage * Cancer Treatment * COVID-19 severity (based on chest X-Ray damage. Low ≤25%, Middle: between 25-50%, High above 50%) * Living Status * Attribution of Mortality to COVID status * Comorbidities | Other | Solid Tumor and COVID-19 |
Primary outcome
Illustration of the repartition of COVID+ patient severity (Low/Medium/Severe status) depending on cancer nature, stage and patient age.
Time frame: At the end of Month 1
COVID-19 severity will be determined based on chest X-Ray damage as follow. Low severity : ≤25% of chest X-Ray damage, Middle severity: between 25-50% of chest X-Ray damage, High Severity : above 50% of chest X-Ray damage. A graphic will then be drafted to present the relationship between Covid-19 severity depending on patient age, cancer nature, and cancer stage.
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 2 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Solid Tumor, run by Hospices Civils de Lyon at 1 site 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 1 inclusion and 1 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 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Illustration of the repartition of COVID+ patient severity (Low/Medium/Severe status) depending on cancer nature, stage and patient age. (time frame: At the end of Month 1). 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 2 Jun 2021.