Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Abemaciclib represents a selective and potent small molecule CDK4 and CDK6 dual inhibitor with broad antitumor activity in preclinical pharmacology models.(oral class) Patients will be instructed to take Abemaciclib orally at a dose of 200mg bid with a glass of water twice daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day

Patients will be instructed to take Abemaciclib orally at a dose of 200mg bid with a glass of water twice daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day

Abemaciclib

Bhumsuk Keam Keam

Bhumsuk Keam, MD

Hye Ryun Kim

Hwan Jung Yun

Myung-Ju Ahn

Sung Bae Kim

Hyun Chang

Sang Hoon Chun

InSook Woo

Yoon Ho Ko

Ji Hyung Hong

jung hye kwon

Heui-june Ahn

Yun Gyoo Lee

Keonuk Park

Eun Joo Kang

Seong-Hoon Shin

Tak Yun

Yoon Hee Choi

Keun-Wook Lee

Joo-Hang Kim

JinSoo Kim

Sang-Cheol Lee

Hyun Woo Lee

Min Kyoung Kim

Hyeok Shim

Seung taek Lim

Kyoung Eun Lee

Moon Young Choi

Joohan Lim

In Gyu Hwang

Hyo Jung Kim

Jun Eul Hwang

Ho Jung An

So Yeon Oh

Sang-Gon Park

Hee Kyoung Ahn

Sun Min Lim

Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck squamous cell carcinoma (FGFR inhibitor, CDK4/6 inhibitor, pan HER inhibitor, PI3K inhibitor, PD1/PD-L1 inhibitor)

This study will be conducted as a treatment arm 4 of the umbrella clinical trial.(NCT03292250)

During or after palliative 1st line platinum based chemotherapy, we will perform prescreening NGS based molecular characterization. The molecular characterization will be done by following three methods.

* NGS : Agilent SureSelect Target Enrichment (245 genes)
* Nanostring nCounter including immune signature
* IHC : PD-L1

The present trial will investigate the efficacy and safety of abemaciclib in patients with recurrent or metastatic HPV (-) HNSCC with genetic alterations of cell cycle pathway who failed to platinum-based therapy. We will also evaluate feasibility and the effect on decision making of next generation sequencing of HNSCC.

During or after palliative 1st line platinum based chemotherapy, we will perform prescreening NGS based molecular characterization.

Molecular tumor board to determine characterization will be held for every patients. Once each patients have relevant genetic pathway, the patients will be allocated each treatment arm

A Biomarker-driven, Open Label, Single Arm, Multicentre Phase II Study of Abemaciclib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Who Failed to Platinum-based Therapy

Overall Survival is defined as the time from first dose to death due to any cause. Through the follow-up within 30 days after study completion or termination of the last subject, death and date of death will be checked for subject alive during treatment period

number of patients with treatment-related AE as assessed by NCI CTCAE version 4.03

Seoul National University Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

120 patients from Carte d'Identité des Tumeurs (CIT), Henri Mondor and Foch hospitals.

510 cystectomy patients operated between 2005 and 2010 in Henri Mondor and Foch hospitals.

188 patients treated by cystectomy and adjuvant chemotherapy for locally advanced bladder cancer from a national multicentric study.

93 patients from the clinical trial GETUG 19 (UNICANCER)

biomarker study

Yves ALLORY, MD, PhD

François RADVANYI, PhD

Muscle invasive (MIBC) and/or metastatic bladder cancer is associated with poor prognosis and no target therapies for this pathology are currently validated. By 40 gene expression signature realized on frozen samples, we have previously identified an aggressive sub-class of MIBC, called basal. This sub-class (20% of MIBC) showed strong EGFR dependence in vitro and in vivo (Rebouissou et al. Science Translational Medicine 2014). This observation suggests a possible response to EGFR targeted therapy in patients of this subgroup. Our aim is to establish a standard diagnostic tool to differentiate the basal subtype of bladder cancer and evaluate the effect of anti-EGFR therapy, by analyzing previous clinical trial (GETUG19) and preclinical models, which compare the classical chemotherapy to anti-EGFR associated chemotherapy.

The aim of this study is:

1. To validate a diagnostic test for formalin-fixed paraffin-embedded (FFPE) samples by Nanostring technology, using the 40 genes signature as reference. First, we will compare frozen and FFPE tissues (n=120), to establish a transcriptional signature in FFPE samples. Secondly, to further characterize basal subtype of bladder cancer, we will study the mutational and gain/loss landscape and immunohistochemistry markers in a new series of tumors after classifying them by our gene signature (n=510). These characteristics will be included in a new signature by defining the optimal prediction discrimination AIC et Net Reclassification Index.
2. To assess the prognosis after cisplatine treatment in 510 patients treated by cystectomy with or without adjuvant chemotherapy (pT2/pT3/pT4, N0 or N+) and in another multicentric series of 188 patients treated by cystectomy and adjuvant chemotherapy (pT3/pT4 et/ou N+). Uni and multi variant analysis will be realized by adjusted Cox model, and the added value of basal subtype as compared to standard prognostic factors will be evaluated. The propensity score will be realized to assess the association of basal subtype and response to chemotherapy. The anti-EGFR response will be analyzed in the clinical trial GETUG19 which uses Panitumumab in patients with metastatic urothelial carcinomas (n=93)
3. To study the treatment response in preclinical models. We characterized previously preclinical murine models derived from xenografts of MIBC (n=14 and new xenografts will be added). We will study the effect of anti-EGFR alone or in combination with chemotherapy in basal and non basal subtypes of xenografts.

By this study we will be able to better characterize the basal subtype of bladder cancer and confirm its aggressive behaviour as compared to other subtypes of MIBC. These results will further help to establish new clinical trials which include anti-EGFR in patients of basal subtype.

Tumor tissue : frozen (n=120), FFPE (n=911)

Basal Like Bladder Cancer : Signature and Therapeutic

Identification and Treatments of Basal Like Bladder Cancer (Study on Human Tumor Samples and Animal Models)

Ministry of Health, France

National Cancer Institute, France

Institut National de la Santé Et de la Recherche Médicale, France

Paris 12 Val de Marne University

Institut Curie

Assistance Publique - Hôpitaux de Paris

Rare Diseases

Medulloblastoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Medulloblastoma, Childhood

Neuroepithelioma

Patients treated with comprehensive treatments including surgery, chemo-therapy with / without (less than 3 y/o) radiation, during the period of Jan 2008 and Dec 2012, whose tumor samples will be tested by NanoString and Histochemistry methods, are enrolled in this cohort group.

Jie MA, MD, Phd

Recently, diagnosis and treatments for medulloblastoma becomes more complicated than before since the new World Health Organization (WHO) diagnosis criteria has put molecular marker onto an ever important position. Reports and studies revealed highly correlated connection between subgroups of medulloblastoma and patient outcomes. Children's Oncology Group (COG) has launched many new studies on molecular subgroups-based specific treatment trails. In China, children and adolescents with brain tumor have been treated variously for a long time in lack of standardized comprehensive treatments. Same poor situation in basic research and clinical studies makes the Chinese children with brain tumor hardly catch up with international level in molecular diagnosis and specific treatments. There are limited studies, which were conducted by immunohistochemistry for identifying medulloblastoma molecular subgroups, indicating the similar correlation of the subgroups and outcomes to world-wide reports. As the Children's Neuro-Oncology Group (CNOG) was established in China in May 2017, it makes studies from multiple centers in children's brain tumors become practical. And the availability of DNA methylation array, NanoString and other methods in medulloblastoma subgroup identification assures the quality of the method for this study.

Studies discovered that medulloblastoma is a group of tumors with different pathogenesis through different pathways, and majorly can be divided into four molecular subgroups. Moreover, multicenter retrospective studies from US, Canada and European Countries revealed that the molecular subgroup of medulloblastoma becomes an independent correlated risk factor for the patient outcomes. This finding made WHO classification of tumours of central nervous system consider the markers in molecular pathway be an ever important indicator in the new diagnosis criteria. In COG prospective studies for target therapies, subgroup distinguishing becomes indispensable, and the use of immunohistochemistry combined with NanoString, DNA methylation arrays or other molecular methods makes subgroup identification more reliable. In China, there are limited single institutional studies, which were all conducted by immunohistochemistry or polymerase chain reaction (PCR), on molecular sub-grouping of medulloblastoma, especially in pediatric patients. This multicenter retrospective study enrolls children and adolescents (0-18y/o) with primary medulloblastoma from CNOG member institutions across the country, with available paraffin embedded samples and reliable follow-up information, to assess the correlation of molecular subgroups of medulloblastoma and outcomes in Chinese population.

This multicenter study recruits eligible patients from CNOG member institutions. Data validation and verification is double conducted by each center and investigators in central data base. Case report form (CRF) was designed by principle investigator and will be modified in the period of uploading first 5 cases by each participated center. The estimated enrollment is 200 cases after sample size assessment. Descriptive statistical analysis, Two-Sample (Independent group) T-Test and one-way ANOVA will be used in epidemiological analysis. Cox-regression / Kaplan-Meier plot will be used in survival analysis. Chi-square test will be used to validate the test efficiency of immunohistochemistry and NanoString methods.

Either paraffin embedded tissue block or frozen tissue

Children's and Adolescents' Medulloblastoma Molecular Subgroups in China

Multi-center Retrospective Study on Clinical Features and Molecular Subgroups of Children and Adolescents With Medulloblastoma in China

The observation period of outcome started with the first medical record available on site till last contact available on site or the end of the observation period (31 December 2017), whichever occurred first.

Children's Neuro-Oncology Group (CNOG)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Head of Department of Pediatric Neurosurgery

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Disease Attributes

Skye Cheng

A recurrence index for distant recurrence (RI-DR), an 18-gene-based clinical-genomic model, has been developed for early-stage breast cancer (EBC). In this study, Investigators compared the prognostic performance of the RI-DR with the Oncotype DX (ODx) recurrence score (RS) for any recurrence risk type.

With improved diagnosis, breast cancer can now be detected at early stages, thus improving survival rates. However, overtreatment is common; considering that the risk of recurrence is low, patients may suffer from side effects without receiving the full benefits of adjuvant therapies.

To overcome the imprecision of prognosis based on clinicopathologic factors, genomic tests for breast cancer prognosis, such as the Oncotype DX® (ODx), MammaPrint®, and EndoPredict® assay kits, are frequently utilized. These multigene panels were development based on Caucasian populations, and may not suitable to Asian population due to the differences in the incidence and lifestyle of breast cancer patients from different ethic backgrounds. To fiil this gap, an 18-gene classifier (18-GC) based on the gene-expression profiling of Chinese breast cancer patients was developed

In the current study, investigators combined clinical variables and genetic information to generate a clinical-genomic model: RI-DR, a recurrence index for distant recurrence (based on a genomic model and 6 clinical variables: age, tumor size, lymph node status, estrogen receptor status, lymphovascular invasion, tumor grading).

By using tissues that have been tested with ODx, in this study, investigators evaluated the performance of the RI-DR model with that of the ODx assay in the prognosis assessment of a cohort of patients from Taiwan.

Parallel Comparison of 18 Gene Classifiers and Oncotype DX (Nanostring)

Head-to-Head Comparison of 18-Gene-Based Clinical-Genomic Model and Oncotype DX 21-Gene Assay for Predicting Recurrence of Early-stage Breast Cancer

LRR risk calculated by 18-GC of breast cancer patients would be classified into high risk

DR risk calculated by 18-GC of breast cancer patients would be classified into high risk

Amwise Diagnostics Pte. Ltd.

Carcinoma, Renal Cell

Kidney Neoplasms

Kidney Diseases

Adenocarcinoma

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Those who present complete response, partial response, or stable disease, according to RECIST 1.1.

Those who present progression disease according to RECIST 1.1.

Evaluation of gene expression profile of a panel with 770 genes related to disease progression using nanostring technology

Gene expression test using nanostring technology.

Renal cell carcinoma accounts for 2-3% of all cancers in western countries. Brazilian kidney cancer data show an incidence of 6,270 new cases for 2018. New target-molecular therapies have emerged in recent years for the treatment of metastatic kidney cancer. Due to the heterogeneity of these patients and the lack of specific markers, therapeutic is currently based on clinical and laboratory analysis. The research for predictive biomarkers may better characterize the kidney cancer therapeutic management. The objectives are to identify a predictive gene expression profile in patients with advanced clear cell renal carcinoma treated with first-line sunitinib and correlate it with rate response, seeking to identify a predictive gene expression profile. As secondary objectives, the investigators will compare the gene expression profile found, with global survival and clinical-pathological characteristics. Materials and methods: To determine through systematic data collection the epidemiological profile, clinical-pathological characteristics, response rate, disease free survival and overall survival of 60 patients with metastatic clear cell renal carcinoma who used sunitinib in the first line between 2009 and 2018 at the Barretos Cancer Hospital. For evaluation of gene expression profile, the investigators will use a panel of a panel with 770 genes related to disease progression using nanostring technology.

Keywords: Renal Cell Carcinoma; Sunitinib; Biomarkers; Gene expression; Nanostring.

The samples retained in a biobank, with potential for RNA extraction, as genetic material was extracted and stored at - 80 degrees celsius, in the form of a just frozen sample/tissue.

Identification of Predictive Gene Expression Profile of Sunitinib Response in Metastatic Clear Cell Renal Carcinomas

Identification of Predictive Gene Expression Profile of Sunitinib Rate Response in Metastatic Clear Cell Renal Carcinomas

Identify differentially expressed genes, through the nanoString platform, in two groups of objective response rate defined using the RECIST 1.1 criteria.

Epidemiological characterization of the metastatic clear cell renal carcinoma population treated with sunitinib in the first line, from Barretos Cancer Hospital and correlate with data from differentially expressed genes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Biomarker-driven, Open Label, Single Arm, Multicentre Phase II Study of Abemaciclib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Who Failed to Platinum-based Therapy	NCT03356587	HNSCC Head and Neck N...	Abemaciclib	20 Years -	Seoul National University Hospital
A Biomarker-driven, Open Label, Single Arm, Multicentre Phase II Study of Abemaciclib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Who Failed to Platinum-based Therapy	NCT03356587	HNSCC Head and Neck N...	Abemaciclib	20 Years -	Seoul National University Hospital
Basal Like Bladder Cancer : Signature and Therapeutic	NCT02648100	Muscle Invasive... Molecular Taxon...	biomarker study	18 Years - 70 Years	Assistance Publique - Hôpitaux de Paris
Children's and Adolescents' Medulloblastoma Molecular Subgroups in China	NCT03288168	Medulloblastoma...		- 18 Years	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Parallel Comparison of 18 Gene Classifiers and Oncotype DX (Nanostring)	NCT03772197	Breast Cancer Recurrence		18 Years - 75 Years	Amwise Diagnostics Pte. Ltd.
Identification of Predictive Gene Expression Profile of Sunitinib Response in Metastatic Clear Cell Renal Carcinomas	NCT04415697	Kidney Cancer Biomarkers Gene Expression	Gene expression...	18 Years -	Barretos Cancer Hospital

Spots Global Cancer Trial Database for nanostring

Every month we try and update this database with for nanostring cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nanostring

Every month we try and update this database with for nanostring cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nanostring cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.