Non Small Cell Lung Cancer
Conditions
Keywords
Molecular residual disease, Adjuvant therapy
Brief summary
Molecular residual disease (MRD) has strong relationship with clinical outcome in multiple solid tumors. Here, the investigators try to verify the negative predictive value of undetectable MRD, which is considered as a superior prognostic factor for resected NSCLC patients, and not requiring excessive adjuvant therapy. Stage IB-IIIA resected NSCLC patients with landmark and longitudinal undetectable MRD are enrolled and under close surveillance in this study.
Detailed description
Stage IB-IIIA resected NSCLC patients will undergo two-round MRD tests after operation, first in 3-7 days and second in 1 month after operation. Patients who confirm two-round landmark undetectable MRD will be enrolled to be under close MRD and imaging monitoring without any adjuvant therapy. Patients who are MRD positive during the two-round MRD screening period will receive treatment and follow-up in accordance with Clinical Practice Guidelines.
Interventions
DIAGNOSTIC_TESTMolecular residual disease test
OncoMRD Lung
Sponsors
Guangdong Association of Clinical Trials
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stage IB-IIIA non-small cell cancer patients who after complete resection. * ≥18 years. * Two-round MRD tests confirm landmark undetectable MRD. * Expected survival ≥12 weeks. * Expected survival ≥12 weeks. * ECOG PS 1-2. * Willing to accept MRD monitoring every 3 months for a total of 2 years after operation.
Exclusion criteria
* Patients who had previously undergone radiotherapy or chemotherapy or any other anti-tumor therapy. * Patients with a history of other malignancies in the past 5 years. * Any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two-years disease free survival rates for patients with longitudinal undetectable MRD | 2 year | The 2-year DFS rate of patients who maintain 2-years undetectable MRD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Two-years disease free survival rates for patients with six months longitudinal undetectable MRD | 2 year | The 2-year DFS rate of patients who maintain 6-months undetectable MRD. |
| Two-years disease free survival rates for patients with 12-months longitudinal undetectable MRD | 2 year | The 2-year DFS rate of patients who maintain 12-months undetectable MRD. |
| Two-years disease free survival rates for patients with 18-months longitudinal undetectable MRD | 2 year | The 2-year DFS rate of patients who maintain 18-months undetectable MRD. |
| Two-years event-free survival rates for enrolled patients in two years | 2 year | The events are defined as disease recurrence or detectable MRD. |
| Two-years disease free survival rates for patients who tested positive for MRD and failed screening during the two-round MRD tests. | 2 year | The 2-year DFS rate of patients who tested positive for MRD and failed screening during the two-round MRD tests. |
Countries
China
Contacts
CONTACTYi-Long Wu, M.D
CONTACTXue-Ning Yang, Ph.D
Outcome results
None listed