NCT06168032Recruiting
COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research
Efficacy of COVID-19 Booster-Dose Vaccine for Re-infection Precaution and Dynamics of Specific Serum Antibodies in the Management of Lung Cancer Patients With Systemic Anti-cancer Treatment
Source: ClinicalTrials.gov · Last updated 13 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1224 (estimated)
- First submitted
- 11 Dec 2023
- Start date
- 8 Dec 2023
- Primary completion date
- 8 Dec 2026
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06168032
What you commit to
- Study type: Interventional
- Planned participants: 1224
- From 8 Dec 2023 to the primary completion date, 8 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with histories of severe treatment-related adverse events graded 3rd or higher, including those caused by antitumor therapies or immunization except recoverable granulocytopenia.
Other illness
- Less than 3 months since last confirmed COVID-19 infection.
- Patients allergic to COVID-19 vaccine.
Other
- Life expectance less than 3 months.
- Patients unable to return the hospital for follow-up.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.