Recruiting

Molecular Testing

Sponsor:

Rhode Island Hospital

Code:

NCT02213822

Conditions

Solid Tumors

Hematological Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Molecular Analysis of Cancer

Study Details

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.

Conditions

Solid Tumors

Hematological Malignancies

Study ID

NCT02213822

Start date

May, 2013

Status verified date

Jul, 2014

Completion date

Aug, 2015

Anticipated

Primary completion date

Aug, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Andrew Schumacher, M.S.

(401) 444-3234

Allison Jean, B.A.

(401) 444- 8856

Locations

Rhode Island Comprehensive Cancer Center at East Greenwich

Recruiting

East Greenwich, Rhode Island, United States, 02818

Contacts

Andrew Schumacher, M.S.

401-444-3234

Allison Jean, B.A.

(401) 444- 8856

Principal Investigator:

Kimberly Perez, M.D.

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Andrew Schumacher, M.S.

401-444-3234

Allison Jean, B.A.

(401) 444- 8856

Principal Investigator:

Kimberly Perez, M.D.

The Miriam Hospital

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

Maureen Jean, R.N.

401-793-4283

Diane Martel, R.N.

(401) 793- 4282

Principal Investigator:

Kimberly Perez, M.D.

More Information

Sponsor

Rhode Island Hospital

Last update posted

Aug 27, 2014

Last verified

Jul, 2014

Keywords

  • genome
  • transcriptome
  • molecular
  • proteome
  • oncogenic mutations
  • sequencing
  • solid tumor
  • hematological malignancy
  • cancer
  • analysis
  • genetic
  • mutation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2014-08-27.