NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,877
- 试验地点
- 1,726
- 主要终点
- Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity
研究概览
简要总结
This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.
详细描述
PRIMARY OBJECTIVES:
I. Characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of coronavirus 2019 (COVID-19), including symptoms, severity, and fatality, in adult and pediatric cancer patients undergoing treatment.
II. Describe cancer treatment modifications made in response to COVID-19 in adult and pediatric patients, including dose adjustments, changes in symptom management, or temporary or permanent cessation.
III. Evaluate the association of COVID-19 with cancer outcomes in adult patient subgroups defined by clinico-pathologic characteristics and in pediatric patients.
EXPLORATORY CORRELATIVE OBJECTIVES:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NCCAPS STUDY ELIGIBILITY CRITERIA:
- •Patient must have a prior or current cancer diagnosis (e.g., solid tumor or hematologic malignancy) and cancer treatment that fits into one of the three following categories:
- •Metastatic (stage IV) solid tumor, any hematologic malignancy, or any central nervous system (CNS) malignancy, and:
- •Patient is receiving eligible active treatment (defined as current treatment or treatment within the 6 weeks prior to their first positive SARS-CoV-2 test collection) or is expected to begin receiving treatment within 2 weeks of study enrollment
- •Eligible active treatment types are chemotherapy, immunotherapy, monoclonal antibody therapy (e.g., rituximab, trastuzumab, cetuximab), targeted therapy (e.g., BRAF/MEK inhibitor, EGF-R inhibitor), endocrine therapy, radiation therapy, or targeted radionuclide therapy; OR
- •Non-metastatic (Stage I-III) solid tumor and:
- •Patient is receiving eligible active treatment (defined as current treatment or treatment within past 6 weeks prior to their first positive SARS-CoV-2 test collection) or is expected to begin receiving treatment within 2 weeks of study enrollment
- •Eligible active treatment types for non-metastatic solid tumor patients are intravenous chemotherapy, immunotherapy, targeted therapy, radiation therapy, targeted radionuclide therapy, or monoclonal antibody therapy (except as noted below)
- •HER2-targeted therapy (trastuzumab, pertuzumab, neratinib, ado-trastuzumab) that is not accompanied by chemotherapy is NOT considered an eligible active treatment
- •Patients on endocrine therapy alone are not eligible; OR
- •Prior or current transplant for the treatment of cancer:
- •Patient has received an allogenic stem cell/bone marrow transplant or chimeric antigen receptor (CAR)-T cell or other modified cellular therapy at any time; or
- •Patient is currently receiving treatment or prophylaxis for graft versus (vs.) host disease; or
- •Patient has received an autologous stem cell/bone marrow transplant within the past 2 years
- •Patient must have documented positive viral test result for SARS-CoV-2
- •For patients 18 years of age or older, the specimen collection for the patient's FIRST positive test must have occurred no earlier than 14 days prior to enrollment
- •For patients under 18 years of age, the specimen collection for the patient's first positive test must have occurred after January 31, 2020
- •The viral test can be either a nucleic acid (polymerase chain reaction [PCR]) test or an antigen test. Serological or antibody tests are not allowed
- •Any specimen source (e.g., nasopharyngeal swab, oropharyngeal swab, etc.) is allowable for the viral SARS-CoV-2 test
- •Patients with prior negative viral SARS-CoV-2 test(s) are eligible if they are being tested again
- •The SARS-CoV-2 test must be a validated diagnostic assay performed in accordance with the most recent guidance issued by the Food and Drug administration (FDA) in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. This policy is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised
- •Human immunodeficiency virus (HIV)-infected patients are eligible
- •Patients with CNS metastases are eligible
- •Co-enrollment on other clinical trials (for cancer or for COVID-19) is allowed
- •PEDIATRIC COVNET COHORT ELIGIBILITY CRITERIA:
- •Patients should only be enrolled in the pediatric COVNET cohort if they are not eligible for the main NCCAPS Study cohort or decline to participate in the main study
- •Patient must be < 18 years of age
- •Patient must have a positive SARS-CoV-2 viral test after January 31, 2020
- •Patient must have a current or prior diagnosis of cancer. Active cancer treatment is not required
- •Note: Patients who enroll on Pediatric COVNET cohort will not be followed longitudinally; study data collection involves only a single questionnaire and research blood collection. A separate consent document is provided for the Pediatric COVNET cohort
排除标准
- 未提供
研究组 & 干预措施
Observational Cohort (data collection, biospecimen collection)
Patients undergo collection of medical information about COVID-19 symptoms, treatments/cancer treatments and outcomes, and results from laboratory tests and imaging scans performed as part of routine care for up to 2 years. Patients also undergo collection of blood samples at the same times they receive routine bloodwork up to 8 times for adults and up to 5 times for children. Patients who are hospitalized for COVID-19 undergo collection of blood samples at up to 6 additional times for adults and up to 3 additional times for children. Adult patients also complete quality of life questionnaire.
干预措施: Biospecimen Collection (Procedure)
Observational Cohort (data collection, biospecimen collection)
Patients undergo collection of medical information about COVID-19 symptoms, treatments/cancer treatments and outcomes, and results from laboratory tests and imaging scans performed as part of routine care for up to 2 years. Patients also undergo collection of blood samples at the same times they receive routine bloodwork up to 8 times for adults and up to 5 times for children. Patients who are hospitalized for COVID-19 undergo collection of blood samples at up to 6 additional times for adults and up to 3 additional times for children. Adult patients also complete quality of life questionnaire.
干预措施: Data Collection (Other)
Observational Cohort (data collection, biospecimen collection)
Patients undergo collection of medical information about COVID-19 symptoms, treatments/cancer treatments and outcomes, and results from laboratory tests and imaging scans performed as part of routine care for up to 2 years. Patients also undergo collection of blood samples at the same times they receive routine bloodwork up to 8 times for adults and up to 5 times for children. Patients who are hospitalized for COVID-19 undergo collection of blood samples at up to 6 additional times for adults and up to 3 additional times for children. Adult patients also complete quality of life questionnaire.
干预措施: Quality-of-Life Assessment (Other)
Observational Cohort (data collection, biospecimen collection)
Patients undergo collection of medical information about COVID-19 symptoms, treatments/cancer treatments and outcomes, and results from laboratory tests and imaging scans performed as part of routine care for up to 2 years. Patients also undergo collection of blood samples at the same times they receive routine bloodwork up to 8 times for adults and up to 5 times for children. Patients who are hospitalized for COVID-19 undergo collection of blood samples at up to 6 additional times for adults and up to 3 additional times for children. Adult patients also complete quality of life questionnaire.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity
时间窗: Up to 2 years
Distinguish the likelihood of severe COVID19 (for example, requiring hospitalization, requiring intensive care unit \[ICU\] treatment or requiring a ventilator) and death due to COVID-19 for patients with versus without the factor. Among subgroups of at least 50 patients, evaluate using chi-square tests as well as death and hospitalization rates.
Physical health (patient-reported health-related quality of life)
时间窗: Up to 2 years
Will be measured using items from the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile.
Effects of COVID-19 on cancer therapy and association with clinical outcomes
时间窗: Up to 2 years
Describe the degree to which COVID-19 interrupts, delays, or otherwise alters cancer treatment for pediatric patients and subgroups of adult patients defined by cancer type and/or treatment modality. Describe the association between changes in cancer therapy and clinical outcomes. Evaluate association of COVID-19 with outcome by comparison to historical controls in subgroups of at least 50 patients using log rank tests to assess time to survival event.
次要结局
未报告次要终点