NCT04784689已完成不适用
Host Immune Response to Novel RNA COVID-19 Vaccination in Patients With Cancer (CTMS# 21-0012)
The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年2月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Antibody response level in patients with cancer to the COVID-19 vaccination.
研究概览
简要总结
To determine the antibody response level in patients with cancer to the COVID-19 vaccination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Must be eligible to receive the COVID19 vaccination by standard and current CDC guidelines. This includes all RNA vaccinations grant EUA status by the FDA
- •Diagnosed with any malignancy within the last 5 years, with the exception of early-stage squamous cell skin cancer, early-stage basal cell skin carcinoma and noninvasive pathology such as DCIS (Ductal Carcinoma in-situ)
- •Able to provide informed consent
- •Patients can be on any form of treatment (including clinical trials) and at any stage (including remission) in their cancer therapy plan - including chemotherapy, immunotherapy, targeted therapy, hormonal therapy, radiation, palliative care or observation.
排除标准
- •Previously documented COVID infection
- •Previously enrolled in a vaccination trial and either still blinded or known to receive the vaccination. (Those patients on a trial but known to receive a placebo dose are eligible to enroll)
- •Contraindication to the vaccination based on current CDC guideline such as know allergic reactions that increase risk of having an allergic reaction to a COVID RNA vaccination. This includes but is not limited to:
- •Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components
- •Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol [PEG])
- •Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)
- •Pregnant or breastfeeding
- •Unable to comply with study related procedures as determined by the study team.
结局指标
主要结局
Antibody response level in patients with cancer to the COVID-19 vaccination.
时间窗: Pre dose on day 1 (baseline), pre dose on day 21, day 35, 6 months, 12 month and 18 months
Antibody response change over time
次要结局
未报告次要终点
研究者
Kate Lathrop
Clinical Investigator
The University of Texas Health Science Center at San Antonio
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Serologic Response to the SARS-CoV-2 (COVID-19) MRNA-1273 Vaccine in Select Subsets of Oncology PatientsCovid19CancerNCT04854980University of Rochester8
终止
4 期
COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2CancerNCT05075538Jules Bordet Institute152
已完成
早期 1 期
Immune Response to the COVID-19 VaccineCovid19MalignancyVaccine Response ImpairedCancerNCT04936997University of Arizona20
已完成
不适用
Efficacy and Safety of COVID-19 Vaccine in Cancer PatientsCOVID-19 InfectionMalignant Solid NeoplasmNCT04865133Mayo Clinic89
进行中（未招募）
1 期
COVID-19: Immune response in patients with cancer undergoing mRNA vaccination against SARS-CoV-2. I-SPARC studyadult cancer patientsMedDRA version: 23.1Level: PTClassification code 10084457Term: COVID-19 immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: PTClassification code 10028997Term: Neoplasm malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-003710-39-PTINSTITUT JULES BORDET525