Covid19COICANCT04569292
COVID-19 Infection in Cancer Pantients
An observational study of Covid19, run by Ospedale Andrea Tortora di Pagani at 1 site in Italy.
Trial summary
It's an obsevational retrospective/prospective study. Analyzing the evolution of COVID 19 infection in cancer patients can provide interesting information in the management of these patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to Aug 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with oncological pathology who contracted COVID 19 infection from January 1, 2020 until the WHO declaration of the end of the pandemic will be studied.
Who may be able to join
- confirmation of COVID-19 in the laboratory (RT-PCR techniques);
- suspected cases of COVID-19; clinically diagnosed based on symptoms (fever> 37.5 °, decrease in oximeter saturation by at least 5%, cough, diarrhea, otitis, dysgeusia, myalgia, arthralgia, conjunctivitis and rhinorrhea) + close contact a COVID-19 subject positive;
- asymptomatic cases; diagnosed based on positive swab results but without symptoms even dead patients
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Oncology Unit, Hospital Andrea Tortora
Pagani, Salerno, 84016
Data Manager Oncology Unit, +390819213683, trialclinici.oncopagani@gmail.com
Data Manager Oncology Unit, +390819213658, trialclinici.oncopagani@gmail.com
About this study
Official title: Clinical Course of Cancer Patients Who Contracted COVID 19 Infection: An Observational Study
It's an obsevational retrospective/prospective study. Analyzing the evolution of COVID 19 infection in cancer patients can provide interesting information in the management of these patients. For this reason, the purpose of this study is to implement a registry to describe and monitor cancer patients affected by COVID 19, the factors that are associated with an unfavorable evolution, to develop a strategy for the risk assessment of these patients and recommendations. relating to their treatment.
Particular attention will be paid to patients suffering from urological tumors because the treatment followed by the patients would seem to expose them to a greater risk when they are infected with coronavirus, furthermore, from the literature it is clear that there may be a connection between sex hormones and ACE2 levels in the plasma. In fact, the estrons up-regulate the concentration of ACE2 in the circulation and this could be the reason why women would seem more protected than men once they contract the coronavirus infection
Read the detailed description
Primary objectives:
- describe cancer patients with COVID-19 and their clinical course;
- identify predictors of the most severe clinical course;
- identify prognostic factors; Secondary objectives
- Monitor patients with urological tumors with particular attention;
- Dosing parameters of inflammation such as IL-6 and IFNα;
- Measure the ACE2 levels.
Patients with oncological pathology who contracted COVID 19 infection from January 1, 2020 until the WHO declaration of the end of the pandemic will be studied.
- Conditions
- Covid19
- Being tested
- No intervention on patients
- Keywords
- COVID-19, Oncological patients, Cancer, Coronavirus infection disease
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention on patientsOther
No intervention on patients
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | * confirmation of COVID-19 in the laboratory (RT-PCR techniques);
* suspected cases of COVID-19; clinically diagnosed based on symptoms (fever> 37.5 °, decrease in oximeter saturation by at least 5%, cough, diarrhea, otitis, dysgeusia, myalgia, arthralgia, conjunctivitis and rhinorrhea) + close contact a COVID-19 subject positive;
* asymptomatic cases; diagnosed based on positive swab results but without symptoms Receives: Other: No intervention on patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
describe cancer patients with COVID-19 and their clinical course
Describing cancer patients with COVID-19 and their clinical course will help us to identify predictors of the most severe clinical course and also prognostic factors
Measured: Almost 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Jan 2020
- Primary completionApr 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Andrea Tortora di Pagani
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Giuseppe Di Lorenzo, Principal investigator, Oncology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569292
- Sponsor's protocol ID
- COICA_PAG_01
- Acronym
- COICA
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Course of Cancer Patients Who Contracted COVID 19 Infection: An Observational Study
- ClinicalTrials.gov ID
- NCT04569292
- Acronym / sponsor ID
- COICA / COICA_PAG_01
- Conditions
- Covid19
- Keywords
- COVID-19, Oncological patients, Cancer, Coronavirus infection disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ospedale Andrea Tortora di PaganiResearch network
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 29 Sep 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.
It's an obsevational retrospective/prospective study. Analyzing the evolution of COVID 19 infection in cancer patients can provide interesting information in the management of these patients. For this reason, the purpose of this study is to implement a registry to describe and monitor cancer patients affected by COVID 19, the factors that are associated with an unfavorable evolution, to develop a strategy for the risk assessment of these patients and recommendations. relating to their treatment.
Particular attention will be paid to patients suffering from urological tumors because the treatment followed by the patients would seem to expose them to a greater risk when they are infected with coronavirus, furthermore, from the literature it is clear that there may be a connection between sex hormones and ACE2 levels in the plasma. In fact, the estrons up-regulate the concentration of ACE2 in the circulation and this could be the reason why women would seem more protected than men once they contract the coronavirus infection
Detailed description
Primary objectives:
- describe cancer patients with COVID-19 and their clinical course;
- identify predictors of the most severe clinical course;
- identify prognostic factors; Secondary objectives
- Monitor patients with urological tumors with particular attention;
- Dosing parameters of inflammation such as IL-6 and IFNα;
- Measure the ACE2 levels.
Patients with oncological pathology who contracted COVID 19 infection from January 1, 2020 until the WHO declaration of the end of the pandemic will be studied.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | Other: No intervention on patients* confirmation of COVID-19 in the laboratory (RT-PCR techniques); * suspected cases of COVID-19; clinically diagnosed based on symptoms (fever> 37.5 °, decrease in oximeter saturation by at least 5%, cough, diarrhea, otitis, dysgeusia, myalgia, arthralgia, conjunctivitis and rhinorrhea) + close contact a COVID-19 subject positive; * asymptomatic cases; diagnosed based on positive swab results but without symptoms |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with oncological pathology who contracted COVID 19 infection from January 1, 2020 until the WHO declaration of the end of the pandemic will be studied.
Key inclusion criteria (3 listed)
- confirmation of COVID-19 in the laboratory (RT-PCR techniques);
- suspected cases of COVID-19; clinically diagnosed based on symptoms (fever> 37.5 °, decrease in oximeter saturation by at least 5%, cough, diarrhea, otitis, dysgeusia, myalgia, arthralgia, conjunctivitis and rhinorrhea) + close contact a COVID-19 subject positive;
- asymptomatic cases; diagnosed based on positive swab results but without symptoms even dead patients
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| No intervention on patientsNo intervention on patients | Other | Cancer patients |
Primary outcome
describe cancer patients with COVID-19 and their clinical course
Time frame: Almost 1 year
Describing cancer patients with COVID-19 and their clinical course will help us to identify predictors of the most severe clinical course and also prognostic factors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Giuseppe Di Lorenzo principal investigator
Oncology Unit
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 Covid19, run by Ospedale Andrea Tortora di Pagani at 1 site in Italy.
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 3 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 29 Sep 2020. 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 Italy. 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?
Contact Data Manager Oncology Unit (+390819213683, trialclinici.oncopagani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
describe cancer patients with COVID-19 and their clinical course (time frame: Almost 1 year). 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 29 Sep 2020.