Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Disease Progression

Neoplasm, Residual

Disease Attributes

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Immunomodulating Agents

For patients with advanced NSCLC who have long-term benefit (PFS 12 months) after first-line immunotherapy

High-depth sequencing method is used to detecting ctDNA.

ctDNA detection

Chunhong Hu, professor

Fang Wu, professor

This study aims to explore the correlation of circulating tumor DNA(ctDNA) and the risk of progression in patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 months)

Evidence suggests that circulating tumor DNA (ctDNA) analysis can noninvasively identify minimal residual disease (MRD) in clinical oncology. The researches will be sharply increased about ctDNA potential clinical application in the near future. In the early stage of NSCLC, ctDNA has been indicated to identify those at high risk of recurrence after radical surgery. And this study will focus on those patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 months). 10ml plasma will be collected every three months until disease progression to interrogate ctDNA by high-depth panel sequencing, exploring its prediction value about the risk of progression. Meanwhile, the investigators would like to explore the lead time of detectable ctDNA before regular imaging finding.

ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC

A Multicenter, Prospective Clinical Study of Circulating Tumor DNA Analysis to Monitor the Risk of Progression After Long-term Benefit to First-line Immunotherapy in Patients With Advanced NSCLC (CR1STAL)

Time from the beginning of first-line immunotherapy to the first progression(PD) in patients with advanced NSCLC.

The correlation of ctDNA and risk of progression during the erolled observation process

Lead time defined as the interval between ctDNA detection and imaging of progression.

the incidence of adverse events during the whole observation time

Overall survival (OS) defined as the duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.

Sun Yat-sen University

First Affiliated Hospital Xi'an Jiaotong University

Fujian Cancer Hospital

Third Affiliated Hospital of Third Military Medical University

Xiangya Hospital of Central South University

Qinghai Province Tumor Hospital

Wuhan Union Hospital, China

Zhejiang Provincial People's Hospital

Hunan Province Tumor Hospital

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Second Affiliated Hospital, School of Medicine, Zhejiang University

Zhejiang Cancer Hospital

The First Affiliated Hospital of Guangzhou Medical University

Inner Mongolia People's Hospital

Guizhou Provincial People's Hospital

The Third Xiangya Hospital of Central South University

Yueyang Central Hospital

ZhuZhou Central Hospital

Zhangjiajie Affiliated Hospital of Hunan Normal University

Loudi Central Hospital

Chang Sha First Hospital

Fang Wu

Associate Professor

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

ctDNA detection, WES and RNA-seq will be performed on blood samples of all patients in this group.

Blood samples are collected from patients at different time points during the monitoring process before treatment, after treatment, after surgery, and after adjuvant therapy/chemotherapy. ctDNA detection is performed on blood samples of all enrolled patients. WES and RNA-seq of samples from patients before and after treatment are performed to reveal the mechanisms of drug resistance.

Wen-Quan Wang, MD, PhD

Wen-hui Lou, MD, PhD

Wen-hui Wen-hui, MD, PhD

The purpose of this study is to evaluate the value of ctDNA detection in the assessment of response rate to neoadjuvant chemotherapy in pancreatic cancer and to explore the correlation between ctDNA clearance and prognosis at different time points. Meanwhile, whole exome sequencing (WES) and RNA Sequencing (RNA-seq) of samples of responders and non-responders to neoadjuvant chemotherapy before and after treatment are performed to explore the mechanisms of drug resistance and provide guidance for clinical decision making.

Pancreatic cancer is highly malignant with poor prognosis, and the overall 5-year survival rate is only about 9%. The value of neoadjuvant therapy in pancreatic cancer has been demonstrated by many studies, and a scientific and accurate evaluation of the efficacy of neoadjuvant therapy is crucial to its implementation and achieving the best outcomes. Circulating tumor DNA (ctDNA) analysis provides a non-invasive way to repeatedly assess the genomic profile of tumor. With improvements in detection techniques providing higher levels of sensitivity, ctDNA analysis is rapidly being accepted as a reliable tool in oncology. The purpose of this study is to evaluate the value of ctDNA detection in the assessment of response rate to neoadjuvant chemotherapy in pancreatic cancer and to explore the correlation between ctDNA clearance and prognosis at different time points. Meanwhile, whole exome sequencing (WES) and RNA Sequencing (RNA-seq) of samples of responders and non-responders to neoadjuvant chemotherapy before and after treatment are performed to explore the mechanisms of drug resistance and provide guidance for clinical decision making.

Application of ctDNA in Evaluation of Neoadjuvant Chemotherapy Efficacy and Exploration of Chemoresistance Mechanisms in Pancreatic Cancer

A Single-center, Observational, Prospective Cohort Study of ctDNA Testing in Evaluation of Neoadjuvant Chemotherapy Efficacy and Exploration of Chemoresistance Mechanisms in Pancreatic Cancer

The IPD will not be shared with other researchers in order to protect patients' privacy.

Pre-treatment ctDNA detection and mutation characterization in blood are used to evaluate objective response rate (ORR) of neoadjuvant therapy in patients with non-metastatic pancreatic cancer.

ctDNA detection is performed to evaluate the rate of adverse reactions to neoadjuvant therapy in patients with non-metastatic pancreatic cancer.

ctDNA detection is performed to analyze the correlation between detection of blood ctDNA and mutation characteristics before treatment and the rate of adverse reactions.

Correlation between postoperative ctDNA in blood and clearance of ctDNA after adjuvant therapy and overall survival (OS) in patients with operable pancreatic cancer.

Blood ctDNA after treatment is used to monitor the recurrence of pancreatic cancer.

Blood ctDNA after treatment is used to compare the timeliness and accuracy of ctDNA with CA19-9 and medical imaging in the detection of disease recurrence.

WES and RNA-seq of tissue samples of pancreatic cancer patients before and after treatment are performed to explore the mechanisms of drug resistance to neoadjuvant chemotherapy.

Fudan University

Amoy Diagnostics Co., LTD

Shanghai Zhongshan Hospital

Neoplasm Metastasis

To detect ctDNA in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)

Si-Yu Wang, MD

zhenguo liu, MD

chao cheng, MD

Zhenguo Liu, MD

Chao Cheng, MD

CtDNA detection is a noninvasive detection method, and the second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. This project is to study the role of ctDNA dynamic monitoring of stage I NSCLC by NGS technique to verify the prognostic predictive effect of ctDNA .

CtDNA detection as a noninvasive detection method, can truly reflect the real tumor tissue gene mutation map and frequency, is the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after treatment. The second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. The ctDNA dynamic monitoring of stage I non-small cell lung cancer (NSCLC) was performed by the second generation gene sequencing (NGS) technique to verify the prognostic predictive effect of ctDNA in stage I NSCLC patients without radiotherapy and targeted therapy.

ctDNA of stage I non-small cell lung cancer (NSCLC)

ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage I NSCLS by NGS

Multicentre, Prospective, Open Clinical Study of Postoperative ctDNA Dynamic Monitoring and Its Role of Prognosis in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)

The investigators will not share IPD to other researchers until initial experimental conclusions is reached.

Disease-free survival was assessed from surgery to disease recurrence or death as a result of any cause

Overall survival was assessed from surgery to death as a result of any cause

First Affiliated Hospital, Sun Yat-Sen University

professor

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

Lumbar punction at diagnosis. CSF and blood samples will be assessed by the two diagnostic tests (CSF ctDNA and conventional test (CC/FC))

Sabrina Chiquet

Noémie Lang, MD

Marc Heizmann, MD

Benjamin Kasenda, MD

Maria Pirosa, MD

Urban Novak, MD

Ulrich Mey, Prof

Gaëlle Rhyner Agocs, MD

Amandine Segot, MD

Michèle Voegeli, MD

Grégoire Berthod, MD

Felicitas Hitz, MD

Christoph Renner, Prof

Adrian Schmidt, MD

Prevention and treatment of CNS relapse remains a great unmet clinical need in the management of aggressive B-NHL. Hence, investigating novel diagnostic tests is of paramount importance to improve risk-stratification of lymphoma patients at diagnosis, as is the evaluation of novel therapeutic approaches that may prevent and / or treat CNS recurrence. Based on the highlighted evidence, the investigators hypothesize that ctDNA detected within the CSF could potentially improve the detection rate of CNS involvement and consequently improve patients' stratification and better discriminate those in need of consolidative CNS prophylaxis on a molecular basis. Similarly, the investigators postulate that CSF ctDNA could be used as a monitoring tool to assess treatment response and guide therapeutic management.

Non-Hodgkin B-cell lymphoma (B-NHL) are cancers that arise from a subtype of white blood cells (lymphocyte) and typically involve the lymphatic system; they represent 4% of all cancers \[SEER database, access 2022\]. Despite booming novel antineoplastic agent development, a significant number of aggressive B-NHL patients continue to succumb to their disease, experiencing rapidly progressive disease or early relapse. Central nervous system or CNS (brain, spinal cord and cerebrospinal fluid (CSF)) involvement in aggressive B-NHL is a rare (2-5%) but it is a devastating event, with a life expectancy ranging between 2 and 5 months \[PMID: 30125215\]. Circulating tumor DNA (ctDNA) represents fragmented DNA that originates from tumors cells, carrying specific cancer-associated mutations that can be detected in the blood or other fluids subsumed under "liquid biopsies".

The role of ctDNA gained momentum with the advent of high throughput sequencing technologies, becoming increasingly relevant for clinical practice. In lymphoma, detecting and monitoring ctDNA has been shown to be feasible and of high prognostic relevance regarding response and relapse. As such, ctDNA is emerging as a promising biomarker that can provide valuable diagnostic and prognostic information \[PMID: 30125215, PMID: 29449275\]. Identification of patients suffering from aggressive B-NHL at high risk of CNS relapse remains extremely challenging and currently mainly relies on a clinical score (CNS-IPI) \[PMID: 27382100\]. The detection of asymptomatic CNS is limited to conventional techniques and is not standardized \[PMID: 22927246\]. In patients with biopsy-proven CNS lymphoma, ctDNA can be detected in CSF (CSF ctDNA) in approximately 95% of cases. Furthermore, CSF ctDNA is predictive of CNS relapse in a small series of neurologically asymptomatic patients with aggressive B-NHL \[PMID: 36542815, PMID: 32079701, PMID: 34551072\]. Prevention and treatment of CNS involvement remains a great unmet clinical need. The discovery of novel and robust biomarkers is of paramount importance for early detection and risk-adapted therapeutic strategies for CNS involvement. The investigators hypothesize that CSF ctDNA is superior to current standard diagnostic procedures (e.g., flowcytometry or cytology) to detect CNS involvement in high-risk patients.

Furthermore, in patients with positive CSF ctDNA, the investigators also postulate that the concept of monitoring minimal residual disease (MRD, small amount of ctDNA that persists in patients that have no signs of active disease on standard imaging techniques) will provide additional information on patient prognosis.

This is a multicenter prospective diagnostic study to compare the performance of experimental diagnostic test (ctDNA) versus conventional cytology (CC) and flow cytometry (FC). Each high-risk B-NHL participant will proceed through standard work-up to evaluate potential CNS involvement including a neurological physical examination, a brain MRI and a diagnostic lumbar puncture. Each participant's CSF will be assessed by the two diagnostic tests (CSF ctDNA and conventional test (CC/FC)); the gold standard being proven CNS lymphoma involvement.

This is a multicenter prospective diagnostic study to compare the performance of experimental diagnostic test (ctDNA) versus conventional cytology (CC) and flow cytometry (FC).

LIBERTY: Liquid Biopsy to Diagnose and Monitor CNS Involvement in High-risk B Cell Non-Hodgkin Lymphoma

LIBERTY: Liquid Biopsy to Diagnose and Monitor Central Nervous System (CNS) Involvement in High-risk B Cell Non-Hodgkin Lymphoma

Sensitivity of liquid biopsy (ctDNA) measured within CSF in its performance to detect CNS involvement in newly diagnosed high-risk B-NHL in comparison to standard conventional diagnostic approaches (CC / FC). For the evaluation of the primary endpoint, only patients with confirmed CNS involvement at baseline (real positives) will be analyzed. CNS involvement at baseline is defined as having at least one of the following conditions:

* Positive brain or spine MRI
* Neurological symptoms of lymphoma manifestations (including ophthalmic symptoms)
* Histologically confirmed CNS involvement

Specificity of liquid biopsy (ctDNA) measured within CSF in its performance to detect CNS involvement in newly diagnosed high-risk B-NHL in comparison to standard conventional diagnostic approaches (CC / FC). For the evaluation of specificity, only patients without CNS involvement at baseline (real negatives) will be analyzed. Absence of CNS involvement at baseline is defined as having none of the following conditions:

* Positive brain or spine MRI
* Neurological symptoms of lymphoma manifestations (including ophthalmic symptoms)
* Histologically confirmed CNS involvement

Time to lymphoma manifestation in the CNS, defined as time from diagnosis to one of the following events, whatever occurs first:

* Clinical neurological symptoms likely related to lymphoma manifestations
* Brain or spine MRI changes compatible with lymphoma involvement
* Histologically confirmed CNS involvement
* Confirmed involvement of the eye (positive CC / FC)
* Death due to lymphoma Patients without lymphoma manifestation in the CNS will be censored at their last tumor assessment by CNS imaging showing non-progression

PFS is defined as the time from diagnosis to lymphoma progression or relapse as per Lugano and / or IPCG criteria, or death whatever occurs first. Patients not having an event at the time of the analysis will be censored at the date of their last tumor assessment showing non-progression.

EFS is defined as the time from diagnosis to lymphoma progression or relapse as per Lugano and / or IPCG criteria, treatment stop without achieving a complete response or death whatever occurs first. Patients not having an event at the time of analysis will be censored at the date of their last tumor assessment showing non-progression. This endpoint will be calculated separately for each treatment line.

OS will be calculated from diagnosis until death from any cause. Patients not experiencing an event will be censored at the last date they were known to be alive.

Overall response rate (ORR) is defined as either PR or CR according to the Lugano criteria. Patients with no tumor assessment will be considered:

* non-ORR, if they have no following tumor assessment within the trial (patient died, refused or was lost to follow-up) or if they have non-ORR at the following tumor assessment after the end of therapy.
* ORR, if they have ORR at the following tumor assessment after end of therapy. This endpoint will be calculated separately for each treatment line.

DOR is evaluated in all patients who achieved a CR after the end of the intended treatment. DOR is defined as time from first complete response until lymphoma progression, relapse or death, whatever occurs first. Response and progression are evaluated according to Lugano criteria. Patients not having an event at the time of analysis will be censored at the date of their last tumor assessment showing non-progression.

Time from first documented MRD positivity (CSF ctDNA detected positive) to first documented MRD negativity. Patients not reaching MRD negativity will be censored at the last time they were known to be MRD positive. Evaluated only in patients with documented MRD positivity at any time.

Swiss Group for Clinical Cancer Research

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Advancd gastric cancer patients received anti-HER2 \& immunotherapy ± chemotherapy

Advancd gastric cancer patients received anti-HER2 ± chemotherapy.

Tissue and peripheral blood sample of 100 gastric cancer patients will be collected at the baseline and time point response of therapy.

Samples including blood and tissue collection

Peripheral blood collected from patients will be administrated to CTC detection.

CTC detection

DNA extraction from patients' peripheral blood will be measured by 741 panel DNA sequence.

Tissue collected from patients will be digested into single cell suspension and administrated to 10×genomics single cell RNA sequence.

10×genomics single cell RNA sequence

DNA will be extracted from patients' tissue and administrated to whole exon sequence.

Whole exon sequence

Peripheral blood collected from patients will be administrated to proximity extension assay .

Proteomics detection

Zhang Xiaotian, MD

Shen Lin, Professor

Shen Lin, professor

Dynamic multiomics explore the efficacy and mechanism of anti-HER2 \& immunotherapy of HER2 Positive GC

The investigators will recruit 100 HER2 positive advanced gastric cancer patients.Blood and tumor tissue will be collected at treatment baseline, every time point response till disease progression. All samples will be processed by next-generation sequence , 10× genomics single-cell sequence ,whole exon sequence, proteome detection and CTC detection to explore the efficacy and mechanism of anti-HER2 \& immunotherapy of HER2 positive GC.

Dynamic Multiomics Evaluation of Anti-HER2 and Immunotherapy in HER2 Positive Gastric Cancer

Numbers of CTC and proportions of HER2 or PD-L1 positive CTC collected at treatment baseline and every time point response will be calculated and recorded. Proportions of HER2 and PD-L1 positive CTC will be compared between two groups.

NGS will be proceeded to detect the ctDNA variations features at treatment baseline and every time point response will be recorded and compared between two groups.

single cell digested from tumor tissue will be administrated to 10× genomics single cell transcriptome sequence. Proportions of lymphocytes, stromal cells, tumor cells assessed by single cell transcriptome sequence at treatment baseline, the second time point response and disease progression time point will be recorded and compared between two groups.

DNA extracted from tumor tissue will be administrated to whole exon sequence.Variation features at treatment baseline, the second time point response and disease progression time point will be recorded and compared between two groups.

96 tumor associated proteins' expression level of tumor at treatment baseline, second time point response and disease progression time point will be recorded and compared between two groups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC	NCT05198154	Advanced Lung N...	ctDNA detection	18 Years - 75 Years	Second Xiangya Hospital of Central South University
Application of ctDNA in Evaluation of Neoadjuvant Chemotherapy Efficacy and Exploration of Chemoresistance Mechanisms in Pancreatic Cancer	NCT05848154	Patients With N... Evaluation of T...	ctDNA detection	18 Years - 75 Years	Shanghai Zhongshan Hospital
ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage I NSCLS by NGS	NCT03172156	Non-small Cell ...	ctDNA detection	18 Years - 75 Years	Sun Yat-sen University
Application of ctDNA in Evaluation of Neoadjuvant Chemotherapy Efficacy and Exploration of Chemoresistance Mechanisms in Pancreatic Cancer	NCT05848154	Patients With N... Evaluation of T...	ctDNA detection	18 Years - 75 Years	Shanghai Zhongshan Hospital
LIBERTY: Liquid Biopsy to Diagnose and Monitor CNS Involvement in High-risk B Cell Non-Hodgkin Lymphoma	NCT06090162	Non-hodgkin Lym...	ctDNA detection	18 Years -	Swiss Group for Clinical Cancer Research
Dynamic Multiomics Evaluation of Anti-HER2 and Immunotherapy in HER2 Positive Gastric Cancer	NCT05348161	HER2 Positive A...	Samples includi... CTC detection ctDNA detection 10×genomics sin... Whole exon sequ... Proteomics dete...	18 Years - 80 Years	Peking University

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