- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04558255
A Preliminary Study on the Detection of Plasma Markers in Early Diagnosis for Lung Cancer
Plasma Biomarkers as a Non-invasive Approach for Early Diagnosis of Lung Cancer
Lung cancer is the most common cancer with the highest morbidity and mortality in the world. Stagement is closely related to the 5 years of survival rate of patients. The postoperative 5-year survival rate is above 90% for stage ⅠA lung cancer patients, while the 5-year survival rate of stage IV lung cancer patients is less than 5%. Therefore, early screening and diagnosis for lung cancer is a key method to reduce lung cancer mortality and prolong survival for patients.
At present, low-dose computed tomography (LDCT) is the most effective method for early detection of lung cancer. In addition to imaging examination, plasma tumor markers detection is also a common clinical detection method for tumor screening and postoperative monitoring.
Liquid biopsy is a non-invasive or minimally invasive method for testing blood or other liquid samples to analyze tumor-related markers including nucleic acids and proteins. Several studies have explored the detection of hot spot gene mutations, methylation and methylation changes of DNA, protein markers and autoantibodies in peripheral blood in lung cancer patients. Liquid biopsy has generally become the most popular field for early diagnosis of lung cancer.
Based above, it is necessary to combine multi-omics methods to improve the detection of early stage lung cancer. In our study, we intend to integrate molecular features obtained through liquid biopsy and clinical data of lung cancer patients, and develop and prospectively validate a machine-learning method which can robustly discriminate early-stage lung cancer patients from controls.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine, 100044
- Recrutement
- Peking University People's Hospital
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Contact:
- Chen Kezhong, M.D.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Enrolled patients are newly diagnosed patients
- In patients diagnosed as pulmonary nodules by imaging, benign and malignant conditions of the nodules are determined by postoperative pathology after surgical resection
- There is clear cancer stage information
- In addition to pulmonary nodules, there are no suspicious nodules of other organs
- No previous history of malignant tumor
Exclusion Criteria:
- Patients with a history of malignant tumor
- Patients with suspectednodules in other parts of the body at the time of diagnosis
- Patients who have previously received surgery, chemotherapy or radiotherapy for pulmonary lesions
- Patients with severe blood lipid in peripheral blood extracted which affects subsequent detection
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Rates of malignant and benign pulmonary nodules measured by the postoperative pathology
Délai: 5 days after the surgery
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After the sugery of each patients with pulmonary nodules, we will get the clinicopathologic characteristics of the patients.
Tumor stage and grade will be evaluated by us and rates of malignant and benign pulmonary nodules will be the primary outcome which we follow.
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5 days after the surgery
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Jun Wang, M.D., Peking University People's Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PTHO1903
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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