- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04567979
Prospective Determination of COVID-19 Infection Rate in a Chemotherapy Unit in Mexico.
Prospective Determination of COVID-19 Infection Rate in Patients With Solid Tumors and Healthcare Workers of the Chemotherapy and Radiotherapy Unit at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador.
연구 개요
상세 설명
In this is prospective cohort, patients with solid tumors and healthcare workers of the chemotherapy and radiotherapy unit at our center will be followed with a daily digital survey and optionally with biweekly PCR tests for SARS-CoV-2. People with symptoms and / or with a positive PCR test for SARS-CoV-2 will be notified and recommendations according to clinical state will be emitted.
Hypothesis: COVID-19 infection rate among patients with solid tumors treated with chemotherapy and / or radiotherapy will be less than 5% during the pandemic period.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Mexico City, 멕시코, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients with solid tumors receiving active oncological treatment (chemotherapy, or radiotherapy or biologic therapy) at our center.
- Age: no limit
- Gender: men and women.
- Health-related worker treating patients with solid tumors at the chemotherapy and radiotherapy unit at our center.
- People who sign an informed consent.
Exclusion Criteria:
- Patients with an hematologic cancer.
- Patients with cancer under surveillance or without active oncological treatment, or receiving treatment in another center.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
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Patients with solid tumors
Patients with solid tumors under chemotherapy and / or radiotherapy treatment at our center.
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Healthcare workers
Healthcare workers at the chemotherapy and radiotherapy unit in our center.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
SARS-CoV-2 infection rate in patients with solid tumors.
기간: From June 2020 to September 2020.
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Determination of SARS-CoV-2 infection rate among patients with solid tumors treated with chemotherapy and / or radiotherapy during the pandemic period.
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From June 2020 to September 2020.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Integration of a cohort of patients with solid tumors receiving oncological treatment.
기간: 4 months
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Identification of patients with solid tumors receiving chemotherapy and / or radiotherapy in our center during the COVID-19 pandemic to get informed consent.
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4 months
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Daily digital follow-up of new-onset respiratory symptoms in the cohort of patients with solid tumors.
기간: 4 months
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To determine the rate of new-onset respiratory symptoms suggestive of COVID-19 among the cohort of patients with solid tumors through a daily digital survey.
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4 months
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SARS-CoV-2 infection rate in the cohort of patients with solid tumors and respiratory symptoms.
기간: 4 months
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To determine the SARS-CoV-2 infection rate in the cohort of patients with solid tumors and respiratory symptoms through a PCR test for SARS-CoV-2.
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4 months
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SARS-CoV-2 infection rate in asymptomatic patients with solid tumors.
기간: 4 months
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To determine the SARS-CoV-2 infection rate in asymptomatic patients with solid tumors through a biweekly PCR test for SARS-CoV-2.
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4 months
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Determination of clinical features and outcomes of cancer patients infected with SARS-CoV-2 .
기간: 4 months
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Determination of demographics, clinical and outcomes of cancer patients infected with SARS-CoV-2.
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4 months
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Integration of a cohort of healthcare workers.
기간: 4 months
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Identification of healthcare workers that treat patients with solid tumors in the chemotherapy and radiotherapy unit at our center to get informed consent.
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4 months
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Daily digital follow-up of new-onset respiratory symptoms in the cohort of healthcare workers.
기간: 4 months
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To determine the rate of new-onset respiratory symptoms suggestive of COVID-19 between the cohort of healthcare workers through a daily digital survey.
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4 months
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SARS-CoV-2 infection rate in the cohort of health-related workers and respiratory symptoms.
기간: 4 months
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To determine the SARS-CoV-2 infection rate in the cohort of healthcare workers with respiratory symptoms through a PCR test for SARS-CoV-2.
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4 months
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SARS-CoV-2 infection rate in asymptomatic healthcare workers.
기간: 4 months
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To determine the SARS-CoV-2 infection rate in asymptomatic healthcare workers through a biweekly PCR test for SARS-CoV-2.
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4 months
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Determination of past infection rate in asymtomatic people through SARS-CoV-2 IgG antibodies detection.
기간: 4 months
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Determination of past infection rate in both cohorts (patients with solid tumors and health-related workers) through IgG antibodies detection at the beginning and at the end of the trial.
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4 months
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Register of oncological patients with solid tumors diagnosed with COVID-19.
기간: 4 months
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To create a register of oncological patients with solid tumors diagnosed with COVID-19.
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4 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Onder G, Rezza G, Brusaferro S. Case-Fatality Rate and Characteristics of Patients Dying in Relation to COVID-19 in Italy. JAMA. 2020 May 12;323(18):1775-1776. doi: 10.1001/jama.2020.4683. No abstract available. Erratum In: JAMA. 2020 Apr 28;323(16):1619.
- Zhang L, Zhu F, Xie L, Wang C, Wang J, Chen R, Jia P, Guan HQ, Peng L, Chen Y, Peng P, Zhang P, Chu Q, Shen Q, Wang Y, Xu SY, Zhao JP, Zhou M. Clinical characteristics of COVID-19-infected cancer patients: a retrospective case study in three hospitals within Wuhan, China. Ann Oncol. 2020 Jul;31(7):894-901. doi: 10.1016/j.annonc.2020.03.296. Epub 2020 Mar 26.
- Yu J, Ouyang W, Chua MLK, Xie C. SARS-CoV-2 Transmission in Patients With Cancer at a Tertiary Care Hospital in Wuhan, China. JAMA Oncol. 2020 Jul 1;6(7):1108-1110. doi: 10.1001/jamaoncol.2020.0980.
- Liang W, Guan W, Chen R, Wang W, Li J, Xu K, Li C, Ai Q, Lu W, Liang H, Li S, He J. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020 Mar;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6. Epub 2020 Feb 14. No abstract available.
- Desai A, Sachdeva S, Parekh T, Desai R. COVID-19 and Cancer: Lessons From a Pooled Meta-Analysis. JCO Glob Oncol. 2020 Apr;6:557-559. doi: 10.1200/GO.20.00097. No abstract available.
- You B, Ravaud A, Canivet A, Ganem G, Giraud P, Guimbaud R, Kaluzinski L, Krakowski I, Mayeur D, Grellety T, Lotz JP. The official French guidelines to protect patients with cancer against SARS-CoV-2 infection. Lancet Oncol. 2020 May;21(5):619-621. doi: 10.1016/S1470-2045(20)30204-7. Epub 2020 Mar 25. No abstract available.
- Sidaway P. COVID-19 and cancer: what we know so far. Nat Rev Clin Oncol. 2020 Jun;17(6):336. doi: 10.1038/s41571-020-0366-2. No abstract available.
- Burki TK. Cancer guidelines during the COVID-19 pandemic. Lancet Oncol. 2020 May;21(5):629-630. doi: 10.1016/S1470-2045(20)30217-5. Epub 2020 Apr 2. No abstract available.
- Marijnen CAM, Peters FP, Rodel C, Bujko K, Haustermans K, Fokas E, Glynne-Jones R, Valentini V, Spindler KG, Guren MG, Maingon P, Calvo FA, Pares O, Glimelius B, Sebag-Montefiore D. International expert consensus statement regarding radiotherapy treatment options for rectal cancer during the COVID 19 pandemic. Radiother Oncol. 2020 Jul;148:213-215. doi: 10.1016/j.radonc.2020.03.039. Epub 2020 Apr 2. No abstract available.
- Verity R, Okell LC, Dorigatti I, Winskill P, Whittaker C, Imai N, Cuomo-Dannenburg G, Thompson H, Walker PGT, Fu H, Dighe A, Griffin JT, Baguelin M, Bhatia S, Boonyasiri A, Cori A, Cucunuba Z, FitzJohn R, Gaythorpe K, Green W, Hamlet A, Hinsley W, Laydon D, Nedjati-Gilani G, Riley S, van Elsland S, Volz E, Wang H, Wang Y, Xi X, Donnelly CA, Ghani AC, Ferguson NM. Estimates of the severity of coronavirus disease 2019: a model-based analysis. Lancet Infect Dis. 2020 Jun;20(6):669-677. doi: 10.1016/S1473-3099(20)30243-7. Epub 2020 Mar 30. Erratum In: Lancet Infect Dis. 2020 Apr 15;: Lancet Infect Dis. 2020 May 4;:
- Qu J, Wu C, Li X, Zhang G, Jiang Z, Li X, Zhu Q, Liu L. Profile of Immunoglobulin G and IgM Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2020 Nov 19;71(16):2255-2258. doi: 10.1093/cid/ciaa489.
- Guo L, Ren L, Yang S, Xiao M, Chang D, Yang F, Dela Cruz CS, Wang Y, Wu C, Xiao Y, Zhang L, Han L, Dang S, Xu Y, Yang QW, Xu SY, Zhu HD, Xu YC, Jin Q, Sharma L, Wang L, Wang J. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Jul 28;71(15):778-785. doi: 10.1093/cid/ciaa310.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HEM-3412-20-20-1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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