All Drugs and Chemicals

Immunomodulating Agents

Nathan Fowler

Krystle Nomie, PhD

The purpose of this project is to develop a comprehensive database of genomic, transcriptomic, molecular, and clinical characteristics of oncology patients to discover, define, and develop genomic and transcriptomic markers to improve future clinical outcomes across cancer types

Immuno- and targeted therapies have shown promising results for many types of cancer (1). However, the effectiveness of these treatments is not optimal for many patients (2). Therefore, further research is needed to discover, define, and develop genomic, transcriptomic, and integrated molecular markers that can improve clinical outcomes across cancer types (3). Unfortunately, current research is restricted by the limited availability of genomic and transcriptomic results linked to clinical outcomes (3). This study will allow for the collection of key clinical data, including longitudinal follow-up, linked with individual genetic and molecular findings in a single comprehensive registry-based databank. Analysis of these data may lead to advances across cancer subtypes through the identification of transcriptomic and genomic associations with therapies.

Clinical and pathological information, including detailed genetic information from a participant's tumor biopsy, will be obtained by the research staff for each participant enrolled in the BIGR Study. Clinical information will include relevant details about the patient's diagnosis and treatment and will be stored in a secure electronic registry database. No extra scans or procedures for this study will be collected as part of this study. Information will be collected regarding a participant's initial diagnosis, treatment, and outcome. To obtain this information, study staff will contact participants or a participant's doctor at regular time intervals for up to 15 years.

BostonGene-Integrated Genomic Registry (BIGR)

BostonGene-Integrated Genomic Registry Study

associations between genomic findings and outcomes of cancer patients who have undergone comprehensive sequencing.

identify molecular findings associated with therapy.

identify and link registry subjects to future molecular-based clinical research

BostonGene

Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Lung Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

The investigators will extract total protein, DNA and RNA from PSC patients.

Integrative Analysis of pulmonary sarcomatoid carcinoma (PSC)

The investigators will analyzed proteomes of paired normal lung tissues and pulmonary sarcomatoid carcinoma with or without metastasis, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal lung tissue, primary pulmonary sarcomatoid carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of lung cancer characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Integrative Analysis of Pulmonary Sarcomatoid Carcinoma (PSC)

There is no plan to make individual participant data (IPD) available to other researchers.

The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

Anhui Medical University

Shanghai 10th People's Hospital

Professor

Nervous System Diseases

Rare Diseases

Glioblastoma

Glioma

Brain Neoplasms

Diffuse Intrinsic Pontine Glioma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Brain Tumor, Childhood

Neuroepithelioma

Children and young adults with newly diagnosed HGG receive an individualized treatment plan. Each treatment is different and depends on what the Specialized Tumor Board recommends depending on the molecular profile of the patient's tumor.

Children and young adults with diffuse midline high grade gliomas receive an individualized treatment plan. Each treatment is different and depends on what the Specialized Tumor Board recommends depending on the molecular profile of the patient's tumor.

Based on the molecular profile, the specialized tumor board will determine an individualized treatment recommendation for each patient using up to four FDA approved drugs. In special circumstances, Investigational new drug (IND) study agents may be used.

Specialized tumor board recommendation

Sabine Mueller, MD, PhD, MAS

This is a 2 strata pilot trial within the Pacific Pediatric Neuro-Oncology Consortium (PNOC).

The study will use a new treatment approach based on each patient's tumor gene expression, whole-exome sequencing (WES), targeted panel profile (UCSF 500 gene panel), and RNA-Seq. The current study will test the efficacy of such an approach in children with High-grade gliomas HGG.

For children with High-grade gliomas (HGG) including HGG presenting within the midline structures of the brain and spine, outcome remains poor and the majority of children die from this disease. The current study will use a new treatment approach based on each patient's tumor gene expression, whole-exome sequencing (WES), targeted panel profile (UCSF 500 gene panel), and RNA-Seq. This treatment strategy has shown promising results in adult patients with solid tumors and is currently being explored in children with DIPG, neuroblastoma and other solid tumors. The current study will test the efficacy of such an approach in children with HGG for which outcomes remain dismal.

Clinical Benefit of Using Molecular Profiling to Determine an Individualized Treatment Plan for Patients With High Grade Glioma

A Pilot Trial Testing the Clinical Benefit of Using Molecular Profiling to Determine an Individualized Treatment Plan in Children and Young Adults With High Grade Glioma (Excluding Diffuse Intrinsic Pontine Glioma)

Individual participant data after de-identification.

Progression Free Survival will be determined from date of confirmation of response to first evidence of progression or death at the 12 month time point.

Overall survival will be determined from the date of histological diagnosis to time of death at the 12 month time point.

Toxicity will be described by reporting Adverse Events (AE). Events will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0. All study-related and unrelated AEs will be collected and reported, together with their maximum intensity among all recorded respective AE.

Toxicity will be described by reporting Serious Adverse Events (SAE). Events will be assessed according to the NCI CTCAE v5.0. All study-related and unrelated Serious Adverse Events (SAE) will be collected and reported, together with their maximum intensity among all recorded respective SAE.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
BostonGene-Integrated Genomic Registry (BIGR)	NCT04991922	Malignancy		18 Years -	BostonGene
Integrative Analysis of Pulmonary Sarcomatoid Carcinoma (PSC)	NCT04215913	Lung Cancer	The investigato...	18 Years - 70 Years	Shanghai 10th People's Hospital
Integrative Analysis of Pulmonary Sarcomatoid Carcinoma (PSC)	NCT04215913	Lung Cancer	The investigato...	18 Years - 70 Years	Shanghai 10th People's Hospital
BostonGene-Integrated Genomic Registry (BIGR)	NCT04991922	Malignancy		18 Years -	BostonGene
Clinical Benefit of Using Molecular Profiling to Determine an Individualized Treatment Plan for Patients With High Grade Glioma	NCT03739372	Glioma Glioma of Brain Cancer Pediatric Cance... Pediatric Brain... Astrocytoma Glioblastoma Hemispheric	Specialized tum...	- 21 Years	University of California, San Francisco

Spots Global Cancer Trial Database for wes

Every month we try and update this database with for wes cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for wes

Every month we try and update this database with for wes 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 wes 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.