Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05673798 |
| Other study ID # |
ChineseSCLC2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2016 |
| Est. completion date |
November 30, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
The Second Hospital of Shandong University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In this retrospective study, patients diagnosed with SCLC between January 2011 to September
2022 were identified from database of the Second Hospital of Shandong University. Following
inclusion criteria should be met: (1) Had histologically or cytologically confirmed newly
diagnosed SCLC; (2) No cancer treatment has been done before; (3) Complete clinical,
laboratory, imaging, treatment data and follow-up information. The exclusion criteria
included: Patients without complete records for pathological information, complete
epidemiology and other key clinical information.
Description:
The investigators classified qualitative variables according to clinical practice. Age
included less than 60 years, 61-66 years, and more than 67 years. The primary tumor location
included left-sided and right-sided. The anatomic sites included lower and others. The
smoking status included never smoker and ever smoker. The forms of performance status
according to the Eastern Cooperative Oncology Group scale (ECOG PS) were ECOG ≤ 2, and ECOG ≥
3. Five groups were formed according to clinical T stage (T0-1, T2, T3, T4, and T stage that
could not be evaluated). Three groups were formed according to clinical N stage (N0-1, N2-3,
and N stage that could not be evaluated). Some stages were unevaluated, on account of a
portion of non-measurable tumor size and lymph node. Three groups were formed according to
clinical M stage (M0, Ma-b, Mc). Four groups were formed according to clinical TNM stage
(Ⅰ-Ⅱ, Ⅲ, Ⅳ and TNM stage that could not be evaluated). The common metastatic sites(brain,
liver, and bone) of tumor was divided into none and yes. The hematologic markers (serum
natrium , lactate dehydrogenase, carcinoembryonic antigen, neuron-specific enolase,
cytokeratin 19 fragment, and pro-gastrin-releasing peptide) were divided into normal and
abnormal. The above information was collected before treatment. The RECIST version 1.0 was
used to assess tumor responses after initial imaging studies of commencing chemotherapy.
Initial chemotherapy response is the first imaging examination of SCLC patient after starting
chemotherapy. Six groups were formed according to initial response to chemotherapy (CR, PR,
SD, PD, response that could not be evaluated, and no chemotherapy). Other treatments
(radiotherapy, surgery, targeted therapy, immunotherapy, Interventional therapy, and
whole-brain prophylactic cranial irradiation) was classified none and yes.
