Whole-Exome Sequencing (WES) of Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02127359|
Recruitment Status : Active, not recruiting
First Posted : April 30, 2014
Last Update Posted : September 6, 2018
Cancers occur when the molecules that control normal cell growth (genes and proteins) are altered. Changes in the tumor genes and in the genes of normal cells are called "alterations." Many of these alterations can be detected by directly examining cancer cells in a tumor or circulating in blood. Several alterations that occur repeatedly in certain types of cancers have already been identified. These discoveries ahve led to the development of new drugs that "target" those alterations. More remain to be discovered.
Some of the alterations are found in genes. Genes are composed of DNA "letters," which contain the instructions that tell the cells in our bodies how to grow and work. Genes make proteins which actually carry out the instructions in our cells.
We would like to use your DNA to look for alterations in the genes in cancer cells and blood cells using a technology called "sequencing." Gene sequencing is a way of reading the DNA to identify errors in genes that may contribute to the behavior of cells. Some changes in genes occur only in cancer cells. Others occur in normal cels as well, in the genes that may have been passed from parent to child. This research study will examine both kinds of genes.
The purpose of this research study is to perform gene sequencing (gene tests) on your cancer cells (obtained from biopsies or surgery) and normal tissues (usually blood). The results of the gene tests will be used to try to develop better ways to treat and prevent cancers. We will also study better ways to communicate the results of these complex gene tests to you and your doctors, and to help you and your doctors use this information to choose the best paths for treatment. As part of this work, we may also learn things about the genes in your normal cells; some of that information will also be shared wtih you and your doctors if you so choose.
Importantly, this study will use tissue specimens that have already been collected and stored in the pathology department as part of your clinical care or as part of other research studies you may be participating in. In this study, gene tests will be performed on material only after the necessary clinical tests have been performed. In general, no additional invasive procedures will be required.
|Condition or disease|
|Lung Adenocarcinoma Colon Adenocarcinoma|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||244 participants|
|Target Follow-Up Duration:||99 Years|
|Official Title:||CanSeq: Whole-Exome Sequencing (WES) of Cancer Patients|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||December 2019|
Metastatic lung and colon adenocarcinomas
- Feasibility of WES in Cancer patients [ Time Frame: 2 years ]To implement a production-scale platform for whole exome sequencing from archival (FFPE) material. To obtain tumor and germline specimens from patients with metastatic cancer who are receiving treatment at Dana-Farber Cancer Institute, beginning with metastatic lung and colon adenocarcinomas. To perform whole exome sequencing on these specimens in order to determine somatic and germline genomic alterations that may be relevant to the development or treatment of cancer. To develop and implement an analytical and interpretive framework to prioritize clinically important genomic alterations.
- Clinical Impact of Whole Exome Sequencing in Cancer Patients [ Time Frame: 2 years ]To determine the clinical impact of somatic and germline whole exome sequencing in cancer patients. To determine the feasibility of whole exome sequencing of clinical cancer patients with advanced solid tumors, beginning with lung and colon adenocarcinomas. To establish a system of review and disclosure of results, including selected incidental results unrelated to the patients' cancer diagnoses, to physicians, patients and their families. To describe the impact of whole exome sequencing data on the medical management of patients with advanced solid tumors.
- Describe Impact of Information Derived from Exome Sequencing [ Time Frame: 2 years ]To describe the impact of information derived from somatic and germline whole-exome sequencing (WES) on cancer patients.
Biospecimen Retention: Samples With DNA
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): NCT02127359
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02215|
|Dana-Farber Cancer Insitute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Nikhil Wagle, MD||Dana-Farber Cancer Insitute|