Observational Retrospective-prospective Study in Patients With Genitourinary Tumors Presenting COVID-19 Infection (SOGUG-COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 410
- 试验地点
- 32
- 主要终点
- Frequency of Complications of COVID-19 Intercurrent Infection
研究概览
简要总结
The identification of patients with genitourinary tumors who suffer from the infection by the Serious Acute Respiratory Syndrome Corona-Virus 2 (SARS-CoV-2) virus can represent multiple benefits both for themselves and for health professionals and the health system itself. We would be able to know more precisely the clinical evolution of these type of patient, to know their prognosis and being capable to select the most appropriate treatment modality for future pandemics.
SOGUG-COVID is an observational prospective-retrospective trial purely epidemiological, that aims to describe the population with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) infected by COrona VIrus Disease 19 (COVID-19) treated in Spanish hospitals, learn about the clinical presentation, therapeutic evolution and prognosis of said intercurrent infectious process, as well as its possible relationship with different clinical and therapeutic factors.
详细描述
The study will be carried out in Spanish hospitals, with principal investigators belonging to the medical oncology services of the SOGUG group (Spanish Group of Genitourinary Oncology), who will act as promoter. Once the patients have been selected, the variables of interest will be collected and studied. The main variables to record will be:
- Patient characteristics
- Hospital center where the patient is recruited
- Pathological history:
Concomitant pathology Usual drug treatment 4. Tumor pathology:
Tumor type, histology, and stage (initial and at diagnosis of infection) Cancer diagnosis date Active cancer treatment or follow-up Participation in clinical trial Type of treatment most recently received for the infection (Surgery; Radiotherapy; Chemotherapy, Immunotherapy ...) Treatment lines, initiation and last dose received of the most recent most recent cancer treatment 5. COVID-19 infection:
Confirmation date of COVID-19 infection PCR (Polymerase Chain Reaction) diagnostic test Immunoglobulin G (IgG) or Immunoglobulin M (IgM) serological diagnostic test Present symptoms, analytical alterations, thrombosis associated with COVID-19 infection, complications of infection Date of onset and disappearance of symptoms Days of fever and cough Radiological examination at the time of greatest severity Treatments received for COVID-19 Status upon discharge Date of discharge / exitus Negative presence of virus by PCR and PCR date 6. For patients who are receiving or have received immunotherapy treatments, additional information will be collected:
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Other
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
- •Patients ≥18 years old.
- •Diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ).
- •COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
- •The COVID-19 infection must be confirmed by PCR or serology, regardless of whether or not the patient requires hospitalization for the infection, additionally, a clinical and / or radiological determination must be available in those patients who present symptoms.
排除标准
- •Not applicable
结局指标
主要结局
Frequency of Complications of COVID-19 Intercurrent Infection
时间窗: Through study completion, average 1 year
Percentage of patients with complications associated to COVID-19 infection (classified by type and severity)
Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment
时间窗: Through study completion, average 1 year
To assess the possible relationship of the different oncological treatments administered to these patients with the clinical evolution of the COVID-19 infection. Complications will be classified by type and severity in groups of patients stratified by the oncological treatment received.
Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)
时间窗: Through study completion, average 1 year
To assess the possible relationship of the different oncological treatments administered to these patients with the clinical evolution of the COVID-19 infection. Complications will be classified by type and severity in groups of patients stratified by the oncological treatment received.
Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment
时间窗: Through study completion, average 1 year
To evaluate in patients with Genitourinary Cancer the impact of androgen deprivation therapy (ADT) and new antiandrogenic agents (NAH) with or without corticosteroids on the infection COVID-19 as mean of frequency in complications of COVID-19 infection classified by type and severity
Age at Baseline
时间窗: Baseline, at the time of inclusion
Describe the population infected by COVID-19 with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) treated in Spanish hospitals, know the clinical presentation: Spcifically here we reported the Age
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
时间窗: Through study completion, average 1 year. Measured at 3 scenarios (during treatment, after treatment and therapies indicated after infection has passed)
To specifically assess the impact of COVID-19 infection on the toxicity of immunotherapy treatment (mainly pneumonitis) and the impact of immunotherapy on the evolution of the infectious picture in patients with tumors of genitourinary origin. three different scenarios: during treatment, after treatment and in patients who receive treatment after the infection has passed.
次要结局
- COVID-19 Mortality Rate in Patients With Genitourinary Cancer(Through study completion, average 1 year)
- COVID-19 Complication Rate in Patients With Genitourinary Cancer(Through study completion, average 1 year)
- Asymptomatic Rate(Through study completion, average 1 year)
- Asymptomatic Rate in Renal Cancer(Through study completion, average 1 year)
- Asymptomatic Rate in Urothelial Cancer(Through study completion, average 1 year)
- Asymptomatic Rate in Prostate Cancer(Through study completion, average 1 year)
- Asymptomatic Rate in Testicular Cancer(Through study completion, average 1 year)
- Frequency of Delays/Modifications on Cancer Treatment Schedule(Through study completion, average 1 year)
- Progression Free Survival in Patients With Genitourinary Tumors That Suffered COVID-19, Patients With a First Line Treatment Ongoing at the Moment of COVID Infection(From start of treatment until progression or death, up to 130 months)
- Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19(From start of treatment until progression or death, up to 130 months)