CancerANTICOVNCT04878796
Effectiveness of mRNA Covid-19 Vaccines on Cancer Patients:Observational Study. (ANTICOV)
An observational study of Cancer and Covid-19, run by Azienda Socio Sanitaria Territoriale di Cremona at 1 site in Italy.
Trial summary
Based on recent data, COVID (COV) vaccination in cancer patients (pts) is strictly recommended. For oncologic pts,2 types of m-RNA vaccines have been approved: BNT162b2 (Pfizer, Biontech) and mRNA-1273 (Moderna, NIAID). In immunocompetent population, the administration of 2 doses confers 95% protection against COV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Covid-19, Vaccine Response
- What is being tested?
- Serum collection, adverse events collection
- Type of treatment
- Vaccines
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 24 May 2021to May 2022
- 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: Cancer patients receiving active therapy (chemotherapy, immonotherapy, target therapy, radiotherapy, hormonal therapy ) or who have completed their oncologic treatment within 6 months and have been prescribed the administration of the admRNAanti-COVID-19 vaccine
Who may be able to join
- Cancer patients receiving active therapy (chemotherapy, immunotherapy, target therapy, radiotherapy)
- Cancer patients receiving hormonal therapy for metastatic disease.
- Must be ≥18 years of age.
- Written, signed consent for study participation.
Who cannot join
- Cancer patients receiving hormonal therapy in adjuvant regimen.
- Patients in follow-up and who have completed their cancer treatment for > 6 months.
- Life expectancy less than 3 months.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
UO Oncologia, ASST di Cremona
Cremona, Lombardy, 26100
Margherita Ratti, MD, 0372405246, mratti.cremona@gmail.com
Rodolfo Passalacqua, MD, 0372405248, rodolfo.passalacqua@asst-cremona.it
About this study
Official title: Observational Study to Monitor the Effects of the COVID-19 Vaccine on Cancer Patients Receiving Active Therapy (ANTICOV).
Based on recent data, COVID (COV) vaccination in cancer patients (pts) is strictly recommended. For oncologic pts,2 types of m-RNA vaccines have been approved: BNT162b2 (Pfizer, Biontech) and mRNA-1273 (Moderna, NIAID). In immunocompetent population, the administration of 2 doses confers 95% protection against COV. However, protection conferred by vaccines, adverse events (AEs) and correlations with antiblastic treatments are unknown in cancer pts.
Read the detailed description
Trial Design
This is a monocentric observational study conducted by the Oncology Unit of Cremona (CR) Hospital, enrolling pts from Oncology, Hematology, Radiotherapy and Palliative Care of Cr Hospital.
This trial aims to prospectively and retrospectively evaluate the effectiveness of mRNA vaccines [BNT162b2 (Pfizer) and mRNA-1273 (Moderna)], the quantization of the antibodies (Abs) response and the onset of AEs in a consecutive population of 300 cancer pts, undergoing antiblastic treatment, starting from March 26Th,2021.
From March, 2021 a vaccination point was set up by Cr Hospital, specific for cancer pts. Vaccine is administered at least 5 days after the last dose of intravenous or oral chemotherapy treatment; the next course of therapy is not administered within the next 3 days. Target therapy and immunotherapy doesn't need interruptions.
- Primary endpoint: Evaluating the protection conferred by vaccination, by detecting the number of symptomatic pts affected by COV, diagnosed 7-60 days after the 2nddose of vaccine. Confirmed of COV infection is defined according to the Food and Drug Administration criteria combined with a nasopharyngeal swab, positive for SARS-Cov-2, obtained during the symptomatic period or within 4 days before or after it.
- Secondary endpoints: Measuring Abs variation at different timepoints compared to baseline. LIAISON SARS-Cov-2 TrimericS IgG and Elecsys anti-SARS-Cov-2 tests will be adopted. The level of Abs will be evaluated at baseline and 30(±7), 180(±7),365(±7)days after the 2nd dose of vaccine;
Describing AEs; Evaluating the interference between vaccine and cancer treatments; Analysis of the Abs subtypes; Duration of abs, up to 12 months after 2nd dose
Statistic Analysis The hypothesis of vaccine inferiority in the trial population is rejected if a rate of protection conferred by the vaccine is observed in 89% of the sample size. The null hypothesis will be rejected if out of a sample size of 300 patients at least 261 are "protected".
The observed proportion of patients with protection will be described by absolute and relative frequency, with Clopper-Pearson confidence intervals. The primary objective will be tested by non-inferiority one-single proportion test, compared with the historical value of 95%. In order to describe the trend of antibody changes in the multiple detections, the ANOVA test for repeated measurements will be used.
- Conditions
- Cancer, Covid-19, Vaccine Response
- Being tested
- Serum collection, adverse events collection
- Keywords
- Cancer treatment, Covid-19, Vaccine
- 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.
Serum collection, adverse events collectionDiagnostic test
Measuring Abs variation at different timepoints compared to baseline. LIAISON SARS-Cov-2 TrimericS IgG and Elecsys anti-SARS-Cov-2 tests will be adopted. The level of Abs will be evaluated at baseline and 30(±7), 180(±7),365(±7)days after the 2nd dose of vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of symptomatic patients affected by COVID-19
Evaluating the protection conferred by vaccination, by detecting the number of symptomatic pts affected by COV, diagnosed 7-60 days after the 2nddose of vaccine. Confirmed of COV infection is defined according to the Food and Drug Administration criteria combined with a nasopharyngeal swab, positive for SARS-Cov-2, obtained during the symptomatic period or within 4 days before or after it.
Measured: 7-60 days after the 2nd dose of vaccine
Secondary outcomes (2)
Antibodies variation at different timepoints
Two tests are used: LIAISON SARS-Cov-2 TrimericSIgG and Elecsys anti-SARS-Cov-2; The combined use of the two dosages in this vaccinated population will allow an assessment of the pre-vaccine immunological status and the characterization of the antibodies produced after the vaccination stimulus
Measured: baseline and 30(±7), 180(±7),365(±7)days after the 2nd dose of vaccine
Adverse Events and interference between vaccine and cancer treatments
collection of AEs in a paper form completed by patients
Measured: from 7 to 90 days after the 2nd dose of vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start24 May 2021
- Primary completionOct 2021 (estimated)
- Study completionMay 2022 (estimated)
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.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale di Cremona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARGHERITA RATTI, MD, Principal investigator, Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878796
- Sponsor's protocol ID
- ASST CR-01-2021
- Acronym
- ANTICOV
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Monitor the Effects of the COVID-19 Vaccine on Cancer Patients Receiving Active Therapy (ANTICOV).
- ClinicalTrials.gov ID
- NCT04878796
- Acronym / sponsor ID
- ANTICOV / ASST CR-01-2021
- Conditions
- Cancer, Covid-19, Vaccine Response
- Keywords
- Cancer treatment, Covid-19, Vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale di CremonaUniversity, hospital or other
- Study start
- 24 May 2021 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 7 May 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.
Based on recent data, COVID (COV) vaccination in cancer patients (pts) is strictly recommended. For oncologic pts,2 types of m-RNA vaccines have been approved: BNT162b2 (Pfizer, Biontech) and mRNA-1273 (Moderna, NIAID). In immunocompetent population, the administration of 2 doses confers 95% protection against COV. However, protection conferred by vaccines, adverse events (AEs) and correlations with antiblastic treatments are unknown in cancer pts.
Detailed description
Trial Design
This is a monocentric observational study conducted by the Oncology Unit of Cremona (CR) Hospital, enrolling pts from Oncology, Hematology, Radiotherapy and Palliative Care of Cr Hospital.
This trial aims to prospectively and retrospectively evaluate the effectiveness of mRNA vaccines [BNT162b2 (Pfizer) and mRNA-1273 (Moderna)], the quantization of the antibodies (Abs) response and the onset of AEs in a consecutive population of 300 cancer pts, undergoing antiblastic treatment, starting from March 26Th,2021.
From March, 2021 a vaccination point was set up by Cr Hospital, specific for cancer pts. Vaccine is administered at least 5 days after the last dose of intravenous or oral chemotherapy treatment; the next course of therapy is not administered within the next 3 days. Target therapy and immunotherapy doesn't need interruptions.
- Primary endpoint: Evaluating the protection conferred by vaccination, by detecting the number of symptomatic pts affected by COV, diagnosed 7-60 days after the 2nddose of vaccine. Confirmed of COV infection is defined according to the Food and Drug Administration criteria combined with a nasopharyngeal swab, positive for SARS-Cov-2, obtained during the symptomatic period or within 4 days before or after it.
- Secondary endpoints: Measuring Abs variation at different timepoints compared to baseline. LIAISON SARS-Cov-2 TrimericS IgG and Elecsys anti-SARS-Cov-2 tests will be adopted. The level of Abs will be evaluated at baseline and 30(±7), 180(±7),365(±7)days after the 2nd dose of vaccine;
Describing AEs; Evaluating the interference between vaccine and cancer treatments; Analysis of the Abs subtypes; Duration of abs, up to 12 months after 2nd dose
Statistic Analysis The hypothesis of vaccine inferiority in the trial population is rejected if a rate of protection conferred by the vaccine is observed in 89% of the sample size. The null hypothesis will be rejected if out of a sample size of 300 patients at least 261 are "protected".
The observed proportion of patients with protection will be described by absolute and relative frequency, with Clopper-Pearson confidence intervals. The primary objective will be tested by non-inferiority one-single proportion test, compared with the historical value of 95%. In order to describe the trend of antibody changes in the multiple detections, the ANOVA test for repeated measurements will be used.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients receiving active therapy (chemotherapy, immonotherapy, target therapy, radiotherapy, hormonal therapy ) or who have completed their oncologic treatment within 6 months and have been prescribed the administration of the admRNAanti-COVID-19 vaccine
Key inclusion criteria (4 listed)
- Cancer patients receiving active therapy (chemotherapy, immunotherapy, target therapy, radiotherapy)
- Cancer patients receiving hormonal therapy for metastatic disease.
- Must be ≥18 years of age.
- Written, signed consent for study participation.
Key exclusion criteria (3 listed)
- Cancer patients receiving hormonal therapy in adjuvant regimen.
- Patients in follow-up and who have completed their cancer treatment for > 6 months.
- Life expectancy less than 3 months.
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 |
|---|---|---|
| Serum collection, adverse events collectionMeasuring Abs variation at different timepoints compared to baseline. LIAISON SARS-Cov-2 TrimericS IgG and Elecsys anti-SARS-Cov-2 tests will be adopted. The level of Abs will be evaluated at baseline and 30(±7), 180(±7),365(±7)days after the 2nd dose of vaccine | Diagnostic test | – |
Primary outcome
Number of symptomatic patients affected by COVID-19
Time frame: 7-60 days after the 2nd dose of vaccine
Evaluating the protection conferred by vaccination, by detecting the number of symptomatic pts affected by COV, diagnosed 7-60 days after the 2nddose of vaccine. Confirmed of COV infection is defined according to the Food and Drug Administration criteria combined with a nasopharyngeal swab, positive for SARS-Cov-2, obtained during the symptomatic period or within 4 days before or after it.
2 secondary outcomes
Antibodies variation at different timepoints
Time frame: baseline and 30(±7), 180(±7),365(±7)days after the 2nd dose of vaccine
Adverse Events and interference between vaccine and cancer treatments
Time frame: from 7 to 90 days after the 2nd dose of vaccine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 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.
MARGHERITA RATTI, MD principal investigator
Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona)
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 Covid-19, run by Azienda Socio Sanitaria Territoriale di Cremona 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 4 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: status not confirmed, as of the sponsor's last update on 28 Jul 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 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 MARGHERITA RATTI, MD (+390372408035, margherita.ratti@asst-cremona.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of symptomatic patients affected by COVID-19 (time frame: 7-60 days after the 2nd dose of vaccine). 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 28 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.