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Research and development of biomarkers for the prediction of cancer risk in patients with pulmonary nodules

Research and development of biomarkers for the prediction of cancer risk in peripheral blood proteomics in patients with pulmonary nodules

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100045508
Enrollment
Unknown
Registered
2021-04-18
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-11-29

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

Conditions

Lung cancer, pulmonary nodules

Interventions

Gold Standard:CT examination confirmed solitary or multiple pulmonary nodules with enlargement within 3 months.
protein&#32
expression.

Sponsors

SpecAlly (Wuhan) Life Technology Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 74 Years

Inclusion criteria

Inclusion criteria: Case group: 1.People at high risk of lung cancer are between (50-74) years old and meet at least one of the following conditions: (1)The number of years of smoking package is not less than 30 years (inclusive year), including having smoked not less than 30 years (inclusive year), but quitting smoking for less than 15 years; (2)Living or working in the same room with (1) passive smoking for more than 20 years; (3)Suffering from chronic obstructive pulmonary disease; (4)Have a history of occupational exposure of not less than one year, including exposure to asbestos, radon, beryllium, chromium, cadmium, silicon, soot and soot; (5)First-degree relatives diagnosed with lung cancer. Note 1: Number of years of smoking packs = number of packs of smoking per day (20 per pack) x years of smoking. Note 2: First-degree relatives refer to parents, children and siblings (with parents). 2.All patients had pulmonary nodules detected by CT and suspected lung cancer (the average diameter of solid nodules or some solid nodules >= 6.0mm and = 8.0mm and < 15.0mm); 3.There are clear serological and imaging reports; 4.All patients had not received any anticancer therapy such as chemotherapy, radiotherapy, molecular targeted therapy, biotherapy or proprietary Chinese medicine with "anti-tumor" effect before blood collection; 5.All patients signed the informed consent to take blood samples, and voluntarily joined the study after the researchers fully informed the contents of the study; 6.Good compliance, understanding ability and barrier-free communication with investigators.

Exclusion criteria

Exclusion criteria: 1.Patients with lung metastases; 2.Patients with tumors in other parts of the body; 3.Patients who do not meet the standards for serum sample collection; 4.Complicated with severe dysfunction of the heart, liver, kidney and other organs; 5.Pregnancy and lactation female patients; 6.Pneumonia or acute respiratory infection treated with antibiotics within 12 weeks prior to qualifying assessment.

Design outcomes

Primary

MeasureTime frame
Nodule size;Sensitivity;Specificity;Accuracy;AUC of ROC;

Countries

China

Contacts

Public ContactHuang Shaoxin
517159865@qq.com+86 17770200320

Outcome results

None listed

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