Immune System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Hypersensitivity

Neoplastic Cells, Circulating

Neoplasm Metastasis

Neoplastic Processes

Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a Driver gene mutation positive.

Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a Driver gene mutation negative.

nonintervention

Yayi He, MD,PHD

Verify the Coincidence rate between Circulating tumor cells (CTCs) and tumor tissue or Circulating tumor DNA (ctDNA) of advanced NSCLC patients with Driver gene mutation

1. Enrich CTCs from advanced Non-Small Cell Lung Cancer (NSCLC) patients with Driver gene mutation, and detect the Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic lymphoma kinase (ALK) fusion, ROS proto-oncogene receptor tyrosine kinase 1 (ROS1) fusion, RET proto-oncogene (RET) fusion and Mesenchymal-Epithelial Transition factor (MET) 14 exon skipping by Lung cancer Polymerase Chain Reaction (PCR) panel kit, and verify the mutation coincidence rate between CTCs and tumor tissue.
2. Enrich ctDNA from advanced NSCLC patients with Driver gene mutation, detect the EGFR mutation by PCR, and detect the ALK fusion, ROS1 fusion, RET fusion and MET 14 exon skipping by next generation sequencing (NGS), and compare the mutation coincidence rate between CTCs and ctDNA.

Clinical Sensitivity Verification Study of Circulating Tumor Cells Gene Mutation Detection From Advanced NSCLC Patients

Analyze the driver gene mutation frequency in CTCs from advanced NSCLC patients with tumor tissue driver gene mutation

Comparison the gene mutation coincidence rate between CTCs and tumor tissue sample

Analyze the driver gene mutation frequency in ctDNA from advanced NSCLC patients with tumor tissue driver gene mutation

Comparison the gene mutation coincidence rate between CTCs and ctDNA

Shanghai Pulmonary Hospital, Shanghai, China

Director Head of Medical Oncology

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients were given only regorafenib orally

The patient was treated with regorafenib orally and in combination with other medications

Shujun Yang, bachelor

Shujun Yang

Real-World Effectiveness of Regorafenib in the Treatment of Patients with Metastatic Colorectal Cancer- A Retrospective, Observational Study

To analyze the real-world usage pattern, effectiveness and factors associated with the effectiveness of regorafenib in the treatment of patients with metastatic colorectal cancer (mCRC). This retrospective, observational study included clinicopathological and follow-up data of patients with mCRC who were treated with regorafenib from June 2017 to September 2020. Patients with incomplete data were excluded. Overall survival (OS) stratified by combination therapy with programmed cell death ligand-1 (PD-L1) inhibitors, chemotherapy and regorafenib dose was calculated by Kaplan Meier method and log rank test. R software version 4.0 was used for the analysis.

Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer

Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer-A Retrospective Study

Survival differences between the monotherapy and combination groups

In the real world, regorafenib was used in different dosages: 40mg,80mg,120mg,160mg,respectively. The difference in overall survival time of patients with different dosage was compared.

In the real world, regorafenib was used in combination with chemotherapy, immunotherapy or other drugs, and the frequency of occurrence of different conditions was analyzed.

To compare the survival of patients with mCRC by gender, age, tumor site and other genotypes

Henan Cancer Hospital

Director

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Real-World Effectiveness of Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma

To analyze the real-world usage pattern, effectiveness and factors associated with the effectiveness of regorafenib in the treatment of patients with Hepatocellular Carcinoma. This retrospective, observational study included clinicopathological and follow-up data of patients with Hepatocellular Carcinoma who were treated with regorafenib from June 2017 to September 2020. Patients with incomplete data were excluded. Overall survival (OS) stratified by combination therapy with programmed cell death ligand-1 (PD-L1) inhibitors, chemotherapy and regorafenib dose was calculated by Kaplan Meier method and log rank test. R software version 4.0 was used for the analysis.

Real-World Effectiveness of Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma-A Retrospective Study

To compare the survival of patients with Hepatocellular Carcinoma by gender, age, tumor site and other genotypes

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a driver gene mutation positive.

Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a driver gene mutation negative.

nonIntervention

Analysis of driver gene variation in early stage non-small cell lung cancer

Fluorescence quantitative polymerase chain reaction (PCR) was used to detect the variation of driver gene in regional lymph nodes of early stage non-small cell lung cancer (NSCLC), and to analyze the relationship between the variation and disease recurrence and survival prognosis. evaluate the effect of the variation of driving gene in lymph nodes of early stage NSCLC on prognosis, identify the high-risk factors that promote the recurrence and metastasis of early stage tumor. so as to improve the diagnosis and treatment path of lung cancer, provide important pathological basis for the clinical diagnosis and treatment of early stage non-small cell lung cancer, enable patients to receive more accurate treatment, and improve their survival prognosis.

Analysis of Driver Gene Mutation in Early Stage Non-small Cell Lung Cancer

Molecular Metastasis in Lymph Nodes is Associated With Survival of Patients With Stage I NSCLC

Observe the driver gene mutation frequency in regional lymph nodes of early stage non-small cell lung cancer

Analyze the correlation between driver gene mutation and clinicopathological features in regional lymph nodes of early stage NSCLC

Observe the correlation between driver gene mutation and survival prognosis in regional lymph nodes of early stage NSCLC

Zhejiang Cancer Hospital

Director of pathology

Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a rare driver gene mutation positive.

Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction(PCR)panel kit in the hospital requires the use of tissue samples and the results show a rare driver gene mutation negative.

Caicun Zhou

Title: Multicenter observational study for clinicopathological characteristics and clinical efficacy of Chinese Non-Small Cell Lung Cancer (NSCLC) patients With Rare Driver Gene Mutation.

Purpose: To observe the status of rare driver gene mutations in NSCLC patients and identify the subtypes of the mutations.

By comparing and analyzing the relationship between different subtypes, clinicopathological features and clinical efficacy, to find out the effects on anti-tumor therapy and disease survival.

And ultimately to promote the precise application of clinical specifications for new anti-tumor drugs.

Study type: Observational

Inclusion criteria:

1. Female or male, 18 years of age or older；
2. Histologically or cytologically proven diagnosis of NSCLC；
3. Able to get tumor tissue gene testing results by lung cancer Polymerase Chain Reaction(PCR)panel kit carried out in hospital
4. Signed and dated informed consent.

Exclusion criteria:

1. Combine with other tumor type
2. The investigator judges the situation that may affect the clinical search process and results.

Estimated enrollment: 50000 participants.

Outcome measures:

Primary outcome measures：

1. The NSCLC rare driver gene mutation frequency and clinicopathological features in 50,000 patients in real world;
2. The relationship between rare driver gene subtypes and clinicopathological features (age, gender, smoking history, histological subtype, clinical stage, lymph node metastasis, local metastasis, distant metastasis, brain metastasis) in NSCLC patients.

Secondary outcome measures:

1. The relationship between rare driver gene mutation subtypes and disease survival or prognosis (Objective response rate (ORR), Progression-free survival (PFS), and Overall survival (OS)) in NSCLC patients.

Method of Research:

1. Pre- entry/screening period (V0)

   1. Screen the enrolled patients according to the admission criteria. The detection of lung cancer PCR panel kit in the hospital requires the use of tissue samples (including surgical tissue, biopsy tissue under interventional conditions, lymph node biopsy tissue, metastases' tissue, etc.);
   2. All enrolled samples should be tested Neurotrophic-Tropomyosin Receptor Kinase (NTRK) gene mutation (PCR);
   3. If a)+b) results show a rare driver gene mutation was detected, participants will be involved into the next step; if a)+b) test results were negative, then 500 cases were selected for next generation sequencing (NGS) detection in this population, and were involved into the next step;
2. Baseline period (V1)

   a. Do further classification of rare driver gene mutation positive samples by Sanger sequencing, and record the test results;
3. Follow-up period (V2)

   1. Record the disease therapeutic regimen and follow-up of the survival status of the enrolled patients;
   2. Once every 3 months (or according to clinical needs) up to 60 months or death;
   3. Collect information including follow-up treatment, disease status, and survival status, imaging examination results, laboratory examination results, etc. (see the Case Report Form (CRF) form for details);
   4. For those who need further molecular testing (such as primary drug resistance), multi-gene analysis using the next generation sequencing (NGS) method;
   5. Loss of follow-up: If the patient fails to return to the center for a follow-up visit, the center will make two attempts to contact by phone and keep the contact records. If the patient does not respond within 1 month after the second contact, the patient is considered to have lost the interview.

Materials and Methods:

Materials:

The specimen material must be human genomic DNA and total RNA extracted from tumor tissue samples. Before the extraction of DNA and RNA, it is very important to make sure that there is at least 20% tumor cells in the tumor tissue samples.

Methods:

Epidermal Growth Factor Receptor 20 exon insertion (EGFR exon 20-ins) mutation/Activin Receptor-like Kinase (ALK) fusion/ROS proto-oncogene 1 receptor tyrosine kinase (ROS1) fusion/Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) mutation/Neuroblastoma RAS viral oncogene homolog (NRAS) mutation/B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutation/Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation/RET proto-oncogene (RET) fusion/Mesenchymal-Epithelial Transition factor (MET) 14 exon skipping/Erb-b2 Receptor Tyrosine Kinase 2 (ERBB2) mutation/ Neurotrophic-Tropomyosin Receptor Kinase (NTRK) fusion mutation were detected by Fluorogenic Quantitative Polymerase Chain Reaction in Chinese NSCLC.

1. DNA/RNA Extraction:

   The total RNA concentration for gene fusion detection is 10\~100 ng/µL in Formalin-Fixed Paraffin-Embedded (FFPE) tissue or 2\~30 ng/µL in Fresh tissue.

   The amount of extracted DNA for gene mutation detection is 1.5\~3 ng/µL in FFPE tissue or 0.5\~1 ng/µL in Fresh tissue.
2. RNA Reverse Transcription.
3. Detection of the Target Alterations in RNA and DNA:

   ALK, ROS1, RET, NTRK Gene fusion and MET 14 exon skipping mutation were detected in RNA.

   EGFR 20 exon-ins, KRAS, NRAS, BRAF, PIK3CA and ERBB2 mutation were detected in DNA.
4. Result Interpretation

Multicenter Observational Study of Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Rare Driver Gene Mutation

Multicenter Observational Study for Clinicopathological Characteristics and Clinical Efficacy of Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Rare Driver Gene Mutation

Analyze the rare driver gene mutation frequency in NSCLC patients in the real world.

Observe the clinicopathological features in NSCLC patients with rare gene mutation in the real world.

Analyze the relationship between rare driver gene subtypes and clinicopathological features in NSCLC patients.

The relationship between rare driver gene mutation subtypes and objective response rate in NSCLC patients.

Objective response rate(ORR): ORR = (number of subjects with complete response (CR) + partial response (PR)) / total number of subjects × 100%, 95% confidence interval(CI) was calculated using binomial distribution, and the calculation of objective response rate was based on the quadratic confirmed optimal efficacy evaluation.

The relationship between rare driver gene mutation subtypes and progression-free survival in NSCLC patients.

Progression-free survival (PFS): PFS refers to the time (month) between the date of randomization to the first demonstration of disease progression or death (whichever occurs first).

The relationship between rare driver gene mutation subtypes and overall survival in NSCLC patients.

Overall survival (OS): OS refers to the time of first use of the drug to the time of death. At the end of the study, if the subject is still alive, refer the known "date of last survival of the subject" as the date of censoring.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Sensitivity Verification Study of Circulating Tumor Cells Gene Mutation Detection From Advanced NSCLC Patients	NCT04229121	Advanced NSCLC Circulating Tum... Circulating Tum...	nonintervention	18 Years -	Shanghai Pulmonary Hospital, Shanghai, China
Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer	NCT05023720	Metastatic Colo...	nonintervention	18 Years - 75 Years	Henan Cancer Hospital
Real-World Effectiveness of Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma	NCT05024539	Hepatocellular ...	nonintervention	18 Years - 75 Years	Henan Cancer Hospital
Analysis of Driver Gene Mutation in Early Stage Non-small Cell Lung Cancer	NCT04266691	Non-small Cell ...	nonIntervention	18 Years -	Zhejiang Cancer Hospital
Multicenter Observational Study of Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Rare Driver Gene Mutation	NCT04137718	Chinese Non-Small Cell ...	nonIntervention	18 Years -	Shanghai Pulmonary Hospital, Shanghai, China
Real-World Effectiveness of Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma	NCT05024539	Hepatocellular ...	nonintervention	18 Years - 75 Years	Henan Cancer Hospital

Spots Global Cancer Trial Database for nonintervention