Hepatocellular CarcinomaCOLLAT-COVIDNCT05932719
Multicentric Evaluation of COVID-19 Impact on Cancer Patients' Diagnostic and Management: Set-up of Indicators
An observational study of Hepatocellular Carcinoma and Peritoneal Carcinoma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The COVID-19 pandemic has deeply and globally impacted usual procedures and patients management in cancer centers. The aim of this study is to set-up and collect indicators to follow-up the activities of different cancer pathologies before and during the pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Peritoneal Carcinoma
- What is being tested?
- COLLAT-COVID is an observational study based on retrospective data issued from patients medial files.
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2022to 1 Dec 2024
- 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 hospitalized in France for peritoneal carcinosis or hepatocellular carcinoma between 2017 and 2020.
Who may be able to join
- Patients hospitalized in France for peritoneal carcinosis or hepatocellular carcinoma between 2017 and 2020.
Who cannot join
- Patients who did not allow the reuse of their medical data for research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Lyon sud, Hospices civils de Lyon
Pierre-Bénite, 69495
Julien PERON, MD, 4 78 86 37 75 ext. +33, julien.peron@chu-lyon.fr
About this study
Official title: Multicentric Evaluation of COVID-19 Impact on Cancer Patients' Diagnostic and Management: Set-up of Indicators to Follow-up the Activities of Different Cancer Pathologies
The COVID-19 pandemic has deeply and globally impacted usual procedures and patients management in cancer centers. The aim of this study is to set-up and collect indicators to follow-up the activities of different cancer pathologies before and during the pandemic. Patients loss' of chance will be analysed in term of diagnosis and access to care (surgery, antineoplastic treatments).
Data collection will focus on the analysis of 2 specific pathologies for French patients in the "Auvergne-Rhône Alpes" Area: peritoneal carcinosis and hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma, Peritoneal Carcinoma
- Being tested
- COLLAT-COVID is an observational study based on retrospective data issued from patients medial files.
- Keywords
- COVID-19, Cancer, Health Care Quality Indicators, hepatocellular carcinoma, peritoneal carcinosis
- Medical subject headings
- Carcinoma, Hepatocellular, COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLLAT-COVID is an observational study based on retrospective data issued from patients medial files.Other
The following items will be collected
- Diagnostic date
- Diagnostic stage
- Date of surgery
- Date of surgery appointment
- First antineoplastic treatment date
- Last antineoplastic treatment date
- Number of treatment cycles recommanded by MDTM
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal Carcinosis | Patients hospitalized for peritoneal carcinosis between 2017 and 2020. Receives: Other: COLLAT-COVID is an observational study based on retrospective data issued from patients medial files. | |
| Hepatocellular Carcinoma | Patients hospitalized for hepatocellular carcinoma between 2017 and 2020. Receives: Other: COLLAT-COVID is an observational study based on retrospective data issued from patients medial files. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of patient loss of chance when comparing a set of activity indicators between 2020 and the average activities of previous periods (2017-2019)
The difference between a set of different activity indicators will be compared between 2020 and the average activities of previous periods (2017-2019)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Dec 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
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
- NCT05932719
- Sponsor's protocol ID
- 69HCL20_0697
- Acronym
- COLLAT-COVID
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Evaluation of COVID-19 Impact on Cancer Patients' Diagnostic and Management: Set-up of Indicators to Follow-up the Activities of Different Cancer Pathologies
- ClinicalTrials.gov ID
- NCT05932719
- Acronym / sponsor ID
- COLLAT-COVID / 69HCL20_0697
- Conditions
- Hepatocellular Carcinoma, Peritoneal Carcinoma
- Keywords
- COVID-19, Cancer, Health Care Quality Indicators, hepatocellular carcinoma, peritoneal carcinosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Jul 2023 (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 COVID-19 pandemic has deeply and globally impacted usual procedures and patients management in cancer centers. The aim of this study is to set-up and collect indicators to follow-up the activities of different cancer pathologies before and during the pandemic. Patients loss' of chance will be analysed in term of diagnosis and access to care (surgery, antineoplastic treatments).
Data collection will focus on the analysis of 2 specific pathologies for French patients in the "Auvergne-Rhône Alpes" Area: peritoneal carcinosis and hepatocellular carcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peritoneal Carcinosis | – | Other: COLLAT-COVID is an observational study based on retrospective data issued from patients medial files.Patients hospitalized for peritoneal carcinosis between 2017 and 2020. |
| Hepatocellular Carcinoma | – | Other: COLLAT-COVID is an observational study based on retrospective data issued from patients medial files.Patients hospitalized for hepatocellular carcinoma between 2017 and 2020. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in France for peritoneal carcinosis or hepatocellular carcinoma between 2017 and 2020.
Key inclusion criteria (1 listed)
- Patients hospitalized in France for peritoneal carcinosis or hepatocellular carcinoma between 2017 and 2020.
Key exclusion criteria (1 listed)
- Patients who did not allow the reuse of their medical data for research
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 |
|---|---|---|
| COLLAT-COVID is an observational study based on retrospective data issued from patients medial files.The following items will be collected * Diagnostic date * Diagnostic stage * Date of surgery * Date of surgery appointment * First antineoplastic treatment date * Last antineoplastic treatment date * Number of treatment cycles recommanded by MDTM | Other | Hepatocellular Carcinoma, Peritoneal Carcinosis |
Primary outcome
Measure of patient loss of chance when comparing a set of activity indicators between 2020 and the average activities of previous periods (2017-2019)
Time frame: 24 months
The difference between a set of different activity indicators will be compared between 2020 and the average activities of previous periods (2017-2019)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
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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.
Hopital Lyon sud, Hospices civils de Lyon
Pierre-Bénite, France
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 Hepatocellular Carcinoma and Peritoneal Carcinoma, 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: status not confirmed, as of the sponsor's last update on 10 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of patient loss of chance when comparing a set of activity indicators between 2020 and the average activities of previous periods (2017-2019) (time frame: 24 months). 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 10 Jul 2023.