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To explore the feasibility of ct DNA monitoring for the efficacy and prognosis prediction of ? ? stage inoperable NSCLC after SBRT

To explore the feasibility of ct DNA monitoring for the efficacy and prognosis prediction of ? ? stage inoperable NSCLC after SBRT

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096848
Enrollment
Unknown
Registered
2025-02-07
Start date
2023-05-04
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

Lung cancer

Interventions

Observation group:None

Sponsors

Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.>=18 years (no upper age limit); 2. Pathologically or cytologically confirmed NSCLC; 3. Stages I-II in the TNM stage of AJCC (8th edition) confirmed by clinicopathological stage; 4. Patients must be considered medically inoperable or refuse surgery; 5. ECOG PS 0-2; 6. For women of childbearing potential, a negative pregnancy test within 2 weeks prior to SBRT treatment; 7. Patient agrees and has the ability to follow the planned study visits, provide pre-treatment tissue specimens, blood specimens pre-treatment, 1 month post-treatment and follow-up, and cooperate with other study steps; 8. Patients must provide clear informed consent prior to study entry; 9. Use of adequate contraception during and for 6 weeks after treatment.

Exclusion criteria

Exclusion criteria: 1.Previous history of malignant tumor, and not cured; 2.There are contraindications to SBRT; 3.Other researchers consider it inappropriate to enroll.

Design outcomes

Primary

MeasureTime frame
RECIST1.1 imaging response;ctDNA positivity rate at different time points;

Secondary

MeasureTime frame
Progression-Free Survival, PFS ;

Countries

China

Contacts

Public ContactLigang Xing

Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)

xinglg@medmail.com.cn+86 531 67616819

Outcome results

None listed

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