Clinical trial NCT03162705: Molecular Profiling in Small Cell Lung Cancer
Official title: Prospective Molecular Profiling in Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Neoplasms
Small Cell Lung Cancer
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
name: Sun Yat-sen University
name: The First Affiliated Hospital of Guangzhou Medical University
First posted: 2017-05-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients have been histologically diagnosed of small cell lung cancer and evaluated with extensive stage.

Brief summary: 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.

Detailed description: Small cell lung cancer (SCLC) is most invasive subtypes of lung cancer. After diagnosis, the SCLC patients without treatment often die in 2-4 months. SCLC is a highly heterogeneous malignant tumor, the previous treatment principle of the tumor is based on the traditional histopathology, which not provide accurate guidance for precise treatment. In recent years, breakthrough has been made in molecular classification of breast cancer, non-small cell lung cancer, gastrointestinal cancer and of the other tumor, but SCLC molecular classification has not yet reported.

In this prospective study, SCLC tissues and blood samples from extensive SCLC patients will be obtained and evaluated of molecular profiling. Eligible population includes: patients who have not undergone any treatment and diagnosed of extensive SCLC by immunohistochemistry(IHC). The purpose is to evaluate molecular profiling of SCLC patients who are sensitive or resistant to chemotherapy (Cisplatin+Etoposide). To compare molecular alterations of SCLC patients with different prognosis (Overall Survival, Progress Free Survival).

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival(OS)
timeFrame: Five years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Five years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital
Study officials:
affiliation: ZhuJiang Hostipal
name: Linlang Guo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyu 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.