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Molecular Testing of Cancer by Integrated Genomic, Transcriptomic, and Proteomic Analysis

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ClinicalTrials.gov Identifier: NCT02213822
Recruitment Status : Unknown
Verified July 2014 by Rhode Island Hospital.
Recruitment status was:  Recruiting
First Posted : August 12, 2014
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital

Brief Summary:

The purpose of this study is to discover genetic changes associated with different cancers. With the information from this study the investigators hope to provide better ways to prevent, detect and treat many cancers.

Many diseases can result from changes in a person's genetic material that causes cells to not work properly. Currently, researchers and doctors know some of the genetic changes that can cause disease, but they do not know all of the genetic changes that can cause disease.

This project is designed to identify genetic changes that can cause cancer in humans. Specimens will be collected from a scheduled diagnostic or routine (i.e. blood draw for counts) procedure and may include samples from the tissue itself (surgery), bone marrow, blood, saliva, urine, spinal fluid, sputum, joint fluid, seminal fluid, ascites (a fluid that fills up in the abdomen), and/or pleural fluid (fluid in the lung cavity), to either confirm the diagnosis of cancer or to help to decide how best to treat cancer or other illness. Additionally archived tissue may be analyzed. Samples may be stored for future use in later experiments. The Department of Pathology at Rhode Island Hospital will store the samples.

Information from the medical record, such as responses to treatments or family history of cancer, will be collected.


Condition or disease Intervention/treatment
Solid Tumors Hematological Malignancies Other: Molecular Analysis of Cancer

Detailed Description:

Complex, progressive, multigenic, somatic mutations of the genome are now widely accepted as the primary driving force in the evolution of cancer initiation, growth, metastasis and pharmacoresistance. Different types of tumors are associated with mutations in distinct sets of genes, and there is a pressing need for a sequencing-based method of analyzing panels of candidate genes that differ for each tumor type.

Traditional approaches to sequence analysis employing capillary electrophoresis-based Sanger sequencing are widely used to guide therapy for patients with lung and colorectal cancer and for melanoma, sarcomas, leukemias and lymphomas. This technology is limited in throughput, scalability, speed, and resolution. The emerging technology such as next-generation sequencing (NGS) - holds a number of advantages over traditional methods, including the ability to fully sequence large numbers of genes in a single test and simultaneously detect deletions, insertions, copy number alterations, translocations, and exome-wide base substitutions in all known cancer-related genes.

Sequencing the whole genome is financially prohibitive for many potentially valuable applications. One alternative to whole genome methods is target enrichment, such as exome sequencing, which captures and sequences only protein coding regions. The exome represents 1-2% of the human genome; however contains the vast majority of disease causing alterations. In addition to exome sequencing, full-length transcriptome (mRNA) sequencing offers a fast and inexpensive alternative. It is an easier method to identify coding sequences and capture variants in genes that are expressed, as well as to generate additional information, such as gene expression level and splicing patterns.

The goal of this study is to investigate genomic, transcriptomic and proteomic alterations in human solid cancers and hematologic malignancies.

Patients >18 y.o. diagnosed with cancer (including any solid tumor or hematologic malignancy) or patients who are undergoing a procedure for the diagnosis of a presumed cancer are eligible.

The research analysis will be performed by the department of pathology or the division of hematology oncology. The body/blood tissue analyzed will be from extra tissue/blood that is not needed for diagnosis or evaluation of the patient's cancer. All samples will be de-identified. Samples will be stored for an indefinite period of time or until all samples are utilized.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: MOLECULAR TESTING OF CANCER BY INTEGRATED GENOMIC, TRANSCRIPTOMIC, AND PROTEOMIC ANALYSIS
Study Start Date : May 2013
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Group/Cohort Intervention/treatment
Pts with Solid Tumors/ Hematological Cancer
Patients on this study must have either a suspected or confirmed solid tumor or hematological cancer. The intervention performed in this study is the molecular analysis of cancer. The samples will be taken at the time of the patient's planned diagnostic or staging procedure. If the patient is scheduled for surgery a sample of tissue not required for their diagnosis will be obtained and used for this research study. If the patient has undergone a previous diagnostic procedure, some of the stored tissue from that procedure will be submitted for molecular analysis as well.
Other: Molecular Analysis of Cancer
The intervention performed in this study is the molecular analysis of cancer. Samples to be tested for genetic alterations will be collected during the course of a routine diagnostic procedure such as a surgery or tumor biopsy. Samples that have been stored from previous diagnostic procedures will be analyzed as well. This testing will be performed by the Department of Pathology at Rhode Island Hospital or an outside laboratory designated by Rhode Island Hospital. The extent of molecular testing will be different in each individual case. For example, in some cases, study of genetic alterations will start with whole genome or exome sequencing and will be confirmed by targeted Sanger resequencing, single nucleotide polymorphism, and transcriptome analysis. In other cases targeted multigene panel sequencing or targeted amplicon Sanger sequencing will be the initial and only step.




Primary Outcome Measures :
  1. The Frequency of "Actionable" Oncogenic Mutations [ Time Frame: 1 year ]
  2. The Prevalence of Genomic, Transcriptomic, and Proteomic Abnormalities in Human Cancer [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Tissue, blood, saliva, body fluid


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients in this study will have either a suspected or confirmed solid tumor or hematological malignancy
Criteria

Inclusion Criteria:

  • Documented informed consent
  • Patient has either a suspected or confirmed solid tumor or hematological malignancy
  • There is enough tissue or body fluid to allow for experimental study
  • The patient is over the age of 18

Exclusion Criteria:

  • The patient is unwilling or unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213822


Contacts
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Contact: Andrew Schumacher, M.S. (401) 444-3234
Contact: Allison Jean, B.A. (401) 444- 8856

Locations
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United States, Rhode Island
Rhode Island Comprehensive Cancer Center at East Greenwich Recruiting
East Greenwich, Rhode Island, United States, 02818
Contact: Andrew Schumacher, M.S.    401-444-3234      
Contact: Allison Jean, B.A.    (401) 444- 8856      
Sub-Investigator: Priscilla Merriam, M.D.         
Sub-Investigator: Howard Safran, M.D.         
Sub-Investigator: Maria Constantinou, M.D.         
Sub-Investigator: Anthony Mega, M.D.         
Principal Investigator: Kimberly Perez, M.D.         
Sub-Investigator: Amy Pilotte, N. P.         
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Andrew Schumacher, M.S.    401-444-3234      
Contact: Allison Jean, B.A.    (401) 444- 8856      
Principal Investigator: Kimberly Perez, M.D.         
Sub-Investigator: Howard Safran, M.D.         
Sub-Investigator: Humera Khurshid, M.D.         
Sub-Investigator: Maria Constantinou, M.D.         
Sub-Investigator: Evgeny Yakirevich, M.D.         
Sub-Investigator: Murray Resnick, M.D.         
Sub-Investigator: James Butera, M.D.         
Sub-Investigator: Mary Anne Fenton, M.D.         
Sub-Investigator: Lucia Fontes-Bortes, N.P.         
Sub-Investigator: Peter Quesenberry, M.D.         
Sub-Investigator: Matthew Quesenberry, M.D.         
Sub-Investigator: John Reagan, M.D.         
Sub-Investigator: Eric Winer, M.D.         
Sub-Investigator: Thomas DiPetrillo, M.D.         
Sub-Investigator: Jaroslaw Hepel, M.D.         
Sub-Investigator: Kara Lynne Leonard, M.D.         
Principal Investigator: David Tracey, P.A.         
Sub-Investigator: Inna Yakirevich, N.P.         
Sub-Investigator: Sharon Benson, N.P.         
Sub-Investigator: Heinrich Elinzano, M.D.         
Sub-Investigator: Timothy Kinsella, M.D.         
Sub-Investigator: Thomas Ng, M.D.         
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Maureen Jean, R.N.    401-793-4283      
Contact: Diane Martel, R.N.    (401) 793- 4282      
Sub-Investigator: Howard Safran, M.D.         
Principal Investigator: Kimberly Perez, M.D.         
Sub-Investigator: Eric Winer, M.D.         
Sub-Investigator: Jennifer Collins, N.P.         
Sub-Investigator: Irene Kolberg, N.P.         
Sub-Investigator: Jodi Layton, M.D.         
Sub-Investigator: Anthony Mega, M.D.         
Sub-Investigator: Priscilla Merriam, M.D.         
Sub-Investigator: Fred Schiffman, M.D.         
Sub-Investigator: John Reagan, M.D.         
Sub-Investigator: Edward Wittles, M.D.         
Sub-Investigator: Angela Taber, M.D.         
Sub-Investigator: Camille Higel-McGovern, N.P.         
Sub-Investigator: Amy Pilotte, N.P.         
Sub-Investigator: Xristin Maestri, N.P.         
Sponsors and Collaborators
Rhode Island Hospital
Investigators
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Principal Investigator: Kimberly Perez, M.D. Lifespan Corporation

Additional Information:

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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT02213822     History of Changes
Other Study ID Numbers: 2055-13
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: July 2014
Keywords provided by Rhode Island Hospital:
genome
transcriptome
molecular
proteome
oncogenic mutations
sequencing
solid tumor
hematological malignancy
cancer
analysis
genetic
mutation
Additional relevant MeSH terms:
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Neoplasms