COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomark… (NCT06168032) | Clinical Trial Compass
RecruitingNot Applicable
COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research
China1,224 participantsStarted 2023-12-08
Plain-language summary
A prospective, open-label and parallel non-randomized control trial and biomarker research study is intended to compare incidence of repeated COVID-19 infection, severe pneumonitis and mortality between lung cancer patients undergoing systemic antitumor therapies who get vaccinated with 1 booster dose(majorly against XBB) and those who refuse. Meanwhile, a biomarker research is designed to monitor serum level dynamics of specific antibodies against COVID-19,analyze its correlation with incidence of breakthrough infection and further explore optimal periods for vaccination.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients who agree to participate in the trial and sign the informed consents.
✓. Male or female, ≥18 years old.
✓. Diagnosed of lung carcinoma by histological and cytological examinations.
✓. Undergoing systemic anti-tumor treatments including chemotherapy, immunotherapy, chemoimmunotherapy and targeted therapy.
✓. Recorded history of COVID19 infection.
✓. Sufficiently functional organs.
✓. Eastern Cooperative Oncology Group performance score (PS) ranging from 0 to 2.
Exclusion criteria
✕. Life expectance less than 3 months.
✕. Less than 3 months since last confirmed COVID-19 infection.
✕. Patients unable to return the hospital for follow-up.
What they're measuring
1
Incidence of recurrent symptomatic COVID-19 infection among lung cancer patients treated with systemic antitumor therapies who get vaccinated 6 months after COVID-19 infection.
✕. Patients with histories of severe treatment-related adverse events graded 3rd or higher, including those caused by antitumor therapies or immunization except recoverable granulocytopenia.