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Gene Methylation Detection Kit for Human Lung Cancer (Real-Time PCR)

Clinical Trial of Lung Cancer Gene Methylation Detection Kit (PCR Fluorescent Probe Method)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100681
Enrollment
Unknown
Registered
2025-04-14
Start date
2025-04-17
Completion date
Unknown
Last updated
2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

Gold Standard:Diagnosis confirmed by imaging and/or pathological examination
Index test:Qualitative detection of HOXB4, SHOX2, and PTGER4 gene methylation in human plasma

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 90 Years

Inclusion criteria

Inclusion criteria: The age and gender of the subjects are not limited, and they can be enrolled if they meet at least one of the following conditions: 1) Clinical manifestations of symptoms suspected to be caused by local growth of the primary tumor of lung cancer, such as coughing, hemoptysis, dyspnea, fever, wheezing, etc; Symptoms and clinical manifestations suspected to be caused by primary lung cancer invading adjacent organs and structures, such as pleural effusion, hoarseness, diaphragmatic nerve paralysis, swallowing difficulties, superior vena cava obstruction syndrome (manifested as swelling of the head, face, and upper limbs, difficulty breathing, coughing, etc.), pericardial effusion, Pancoast syndrome (characterized by persistent and severe shoulder pain, axillary pain, and upper limb pain, ptosis of the affected eyelid, sunken eyeball, pupil constriction, lack of sweat on the affected face, and sensory abnormalities, etc.); Or there may be symptoms suspected to be caused by distant metastasis of the primary lung cancer tumor, such as headaches, nausea, vomiting and other symptoms due to central nervous system metastasis, and severe and progressive pain symptoms due to bone metastasis; 2) Suspected clinical manifestations of lung cancer, with unexplained and persistent extrapulmonary signs during physical examination, such as clubbing fingers (toes), non migratory joint pain, male breast development, dark skin or dermatomyositis, ataxia, and phlebitis; 3) Suspected clinical manifestations of lung cancer, physical examination revealed liver enlargement accompanied by nodules, subcutaneous nodules, and enlarged lymph nodes in the supraclavicular fossa; 4) Suspected clinical manifestations of lung cancer, with abnormal elevation of tumor markers related to serological tests, such as carcinoembryonic antigen (CEA), neuron specific enolase (NSE), cytokeratin 19 fragment (CYFRA21-1) and progastrin releasing peptide (ProGRP), as well as squamous cell carcinoma antigen (SCC), etc 5) Previous or recent imaging examinations (X-ray/CT/MRI/ultrasound/nuclear imaging/PET, etc.) have shown pulmonary nodules, suspected to be lung cancer; 6) Diagnosed as lung cancer (patients who have not undergone surgery, radiotherapy, chemotherapy, targeted drug therapy for the first time, or patients who have relapsed for the first time and have not received treatment) and benign disease population; 7) Clearly diagnosed as other primary cancers (liver cancer, stomach cancer, esophageal cancer, colorectal cancer, etc.).

Exclusion criteria

Exclusion criteria: If the subject meets any of the following criteria, they cannot be selected: 1) The patient has contraindications for venous blood collection; 2) The patient has already participated in this study; 3) Researchers believe that patients with other conditions should not participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
sensitivity;Specificity;Kappa value;

Secondary

MeasureTime frame
positive agreement rate;negative agreement rate;

Countries

China

Contacts

Public ContactSun Baoqing

The First Affiliated Hospital of Guangzhou Medical University

wu.zhen@biochainbj.com+86 20 8156 6267

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026