Breast CancerCANINENCT04821570
To Assess Immunogenicity of Coronavirus Disease 2019 (COVID-19) Vaccine in Cancer Patients Receiving Cancer Treatment
An observational study of Breast Cancer and Lung Cancer, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This is a trial of prospective collection of serial blood samples after administration of COVID-19 vaccine in patients with cancer who are receiving active cancer treatment, planned to start therapy with 14 days of consent, or have had stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Melanoma (Skin)
- What is being tested?
- COVID-19 Vaccine
- Type of treatment
- Vaccines
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2021to 28 Mar 2025
- 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
- Adult, Older adult
Study population: Participants undergoing treatment for breast cancer, lung cancer and melanoma with chemotherapy, immunotherapy and/or oral anticancer agents, or have undergone stem cell transplantation
Who may be able to join
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- Males and females age ≥ 18 years
- Patients with breast cancer, lung cancer, malignant melanoma or who have undergone stem cell transplant or chimeric antigen receptor (CAR) T cell therapy for a hematologic malignancy.
- Other cancer types including hematologic malignancies may be allowed if they are receiving treatments outlined in section 4.1.4
- Solid Tumor patients and those with hematologic malignancies: Currently receiving active anti-cancer therapy, or planned to start within 14 days, with intravenous cytotoxic chemotherapy (oral or intravenous), intravenous chemoimmunotherapy combination, immunotherapy alone, an oral CDK 4/6 inhibitor. (This does not apply to recipients of stem cell transplant and CAR T therapy)
- Therapy may be neo/adjuvant or for metastatic disease
- Eastern Cooperation Oncology Group (ECOG) Performance status (PS) of 0-2
Who cannot join
- Life expectancy of < 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
About this study
Official title: Cancer Therapy and Immunogenicity of COVID Vaccine (CANINE Trial)
This is a trial of prospective collection of serial blood samples after administration of COVID-19 vaccine in patients with cancer who are receiving active cancer treatment, planned to start therapy with 14 days of consent, or have had stem cell transplant. Cancer treatments and administration of vaccine are not controlled by the study.
- Conditions
- Breast Cancer, Lung Cancer, Melanoma (Skin)
- Being tested
- COVID-19 Vaccine
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccineBiological
Per recommended dosing schedule
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy (IV and oral) | Not described Receives: Biological: COVID-19 Vaccine | |
| Immunotherapy | Not described Receives: Biological: COVID-19 Vaccine | |
| Chemotherapy + Immunotherapy | Not described Receives: Biological: COVID-19 Vaccine | |
| Cyclin- dependent kinase (CDK) 4/6 inhibitors | Not described Receives: Biological: COVID-19 Vaccine | |
| Stem Cell Transplant recipients | Not described Receives: Biological: COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT) with corresponding 95%confidence interval (CI) at each time point of the entire population and individually of all cohorts
Elecsys Anti severe acute respiratory syndrome (SARS) coronavirus 2 (CoV 2) S quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201.
Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts
Elecsys Anti SARS CoV 2 S quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts
Elecsys Anti SARS CoV 2 S quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline
Elecsys Anti SARS CoV 2 S quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline
Elecsys Anti SARS CoV 2 S quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer baseline, Day 21, Day 51, Day 111, Day 201
Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline
Elecsys Anti SARS CoV 2 S quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
Secondary outcomes (21)
Geometric median, minimum and maximum assay titer values for each cohort
Elecsys Anti SARS CoV 2 S quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
Geometric median, minimum and maximum assay titer values for each cohort
Elecsys Anti SARS CoV 2 S quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
Geometric median, minimum and maximum assay titer values for each cohort
Elecsys Anti SARS CoV 2 S quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
Elecsys Anti SARS CoV 2 quantitative assay
Measured: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start23 Feb 2021
- Primary completion28 Mar 2024 (estimated)
- Study completion28 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qamar Khan, MD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821570
- Sponsor's protocol ID
- IIT-2021-CANINE
- Acronym
- CANINE
- Status last verified
- Apr 2023
- First submitted
- 26 Mar 2021
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Therapy and Immunogenicity of COVID Vaccine (CANINE Trial)
- ClinicalTrials.gov ID
- NCT04821570
- Acronym / sponsor ID
- CANINE / IIT-2021-CANINE
- Conditions
- Breast Cancer, Lung Cancer, Melanoma (Skin)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 28 Mar 2024 (estimated)
- Study completion
- 28 Mar 2025 (estimated)
- First posted
- 29 Mar 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.
This is a trial of prospective collection of serial blood samples after administration of COVID-19 vaccine in patients with cancer who are receiving active cancer treatment, planned to start therapy with 14 days of consent, or have had stem cell transplant. Cancer treatments and administration of vaccine are not controlled by the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy (IV and oral) | – | Biological: COVID-19 Vaccine |
| Immunotherapy | – | Biological: COVID-19 Vaccine |
| Chemotherapy + Immunotherapy | – | Biological: COVID-19 Vaccine |
| Cyclin- dependent kinase (CDK) 4/6 inhibitors | – | Biological: COVID-19 Vaccine |
| Stem Cell Transplant recipients | – | Biological: COVID-19 Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants undergoing treatment for breast cancer, lung cancer and melanoma with chemotherapy, immunotherapy and/or oral anticancer agents, or have undergone stem cell transplantation
Key inclusion criteria (7 listed)
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- Males and females age ≥ 18 years
- Patients with breast cancer, lung cancer, malignant melanoma or who have undergone stem cell transplant or chimeric antigen receptor (CAR) T cell therapy for a hematologic malignancy.
- Other cancer types including hematologic malignancies may be allowed if they are receiving treatments outlined in section 4.1.4
- Solid Tumor patients and those with hematologic malignancies: Currently receiving active anti-cancer therapy, or planned to start within 14 days, with intravenous cytotoxic chemotherapy (oral or intravenous), intravenous chemoimmunotherapy combination, immunotherapy alone, an oral CDK 4/6 inhibitor. (This does not apply to recipients of stem cell transplant and CAR T therapy)
Key exclusion criteria (1 listed)
- Life expectancy of < 12 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 |
|---|---|---|
| COVID-19 VaccinePer recommended dosing schedule | Biological | Chemotherapy (IV and oral), Chemotherapy + Immunotherapy, Cyclin- dependent kinase (CDK) 4/6 inhibitors, Immunotherapy, Stem Cell Transplant recipients |
Primary outcome
Geometric mean titer (GMT) with corresponding 95%confidence interval (CI) at each time point of the entire population and individually of all cohorts
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201.
Elecsys Anti severe acute respiratory syndrome (SARS) coronavirus 2 (CoV 2) S quantitative assay
Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
Elecsys Anti SARS CoV 2 S quantitative assay
Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
Elecsys Anti SARS CoV 2 S quantitative assay
Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
Elecsys Anti SARS CoV 2 S quantitative assay
Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer baseline, Day 21, Day 51, Day 111, Day 201
Elecsys Anti SARS CoV 2 S quantitative assay
Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
Elecsys Anti SARS CoV 2 S quantitative assay
21 secondary outcomes
Geometric median, minimum and maximum assay titer values for each cohort
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
Geometric median, minimum and maximum assay titer values for each cohort
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
Geometric median, minimum and maximum assay titer values for each cohort
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Qamar Khan, MD principal investigator
University of Kansas
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 Breast Cancer and Lung Cancer, run by University of Kansas Medical Center at 1 site in United States.
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 7 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 4 Apr 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 United States. 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?
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?
Geometric mean titer (GMT) with corresponding 95%confidence interval (CI) at each time point of the entire population and individually of all cohorts (time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201.). The study lists 6 primary outcomes in all. 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 4 Apr 2023.