Clinical trial · Observational
Molecular Profiling in Small Cell Lung Cancer
Prospective Molecular Profiling in Small Cell Lung Cancer
NCT03162705CI-TRIAL-00036653MPSCLCunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This protocol is to obtain tumor tissues and blood samples from patients with a confirmed histological diagnosis of Small cell lung cancer(SCLC) for molecular profiling.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival(OS)
- timeFrame
- Five years
- description
- OS is defined as time duration from randomization until the date of death from any cause. If the participants who had survived after the end of the study, or loss of follow-up, their last time of contact is defined as a deadline.
Secondary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- Five years
- description
- PFS is defined as time duration from randomization until the date of SD(Stable Disease) or PD(Progressed Disease) evaluated by WHO RECIST (World Health Organization Response Evaluation Criteria in Solid Tumors， Edition1.1).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age: between 18 and 75 years old. * Sexes Eligible for Study: All * Diagnosed of SCLC by IHC, and divided into extensive stage. * The ECOG (Eastern Cooperative Oncology Group, ECOG) PS(performance status，PS) Scale score is 0 or 1. * At least one measurable lesions by CT scan. * Expect to survive for at least three months. * Peripheral blood routine and liver and kidney function meet the following criterion (blood draw 7 days before the treatment begins) : * The White Blood Cell (WBC) is greater than the 3.0×10\^9/L or neutrophils (ANC) more than 1.5 x10\^9/L; * Hemoglobin (HGB) is greater than 80 g/L. * Platelet (PLT) is greater than 100×10\^9/L. * (AST/ALT): Aspartate aminotransferase/Alanine aminotransferase\<3.0 times of normal range. * Total bilirubin (TBIL) \< 1.5 times of normal range. * Creatinine (CREAT) \< 1.5 times of normal range. * Female or male patients must adopt effective birth control measures. * Informed consent forms provided. Patients must meet each of the above criteria. Exclusion Criteria: * Other pathological types of tumors ,rather than small cell lung cancer. * Incorporating other tumors in the early diagnosis; * Patients who have received chemotherapy, radiotherapy or any other anti-cancer treatment. * Patients that known to be allergic to the drug components involved in the study; * Patients with severe allergies or allergies; * Pregnant or breastfeeding women; * Patients with acute infection which is difficult to control; * Drug abuse, substance abuse, long-term alcohol and AIDS(Acquired Immune Deficiency Syndrome) patients. Candidates who meet each of the exclusion criteria will not included in the research.
References
Publications (1)
- DERIVEDLyu Q, Zhu W, Wei T, Ding W, Cao M, Wang Q, Guo L, Luo P, Zhang J. High mutations in fatty acid metabolism contribute to a better prognosis of small-cell lung cancer patients treated with chemotherapy. Cancer Med. 2021 Nov;10(21):7863-7876. doi: 10.1002/cam4.4290. Epub 2021 Sep 26. PMID 34564955