Lung AdenocarcinomaNCT02127359
Whole-Exome Sequencing (WES) of Cancer Patients
An observational study of Lung Adenocarcinoma and Colon Adenocarcinoma, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Adenocarcinoma, Colon Adenocarcinoma
- How many people
- 244 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Dec 2019
- How long will I take part?
- 99 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dana-Farber Cancer Institute patients who are identified as oncology patients or patients suspected to have an eligible cancer diagnosis as defined by their providers.
Who may be able to join
- Have previously consented to DF/HCC Protocol 11-104, 02-180 and/or are currently receiving clinical testing for KRAS mutations at BWH
- Have a diagnosis of advanced lung or colorectal adenocarcinoma
- Life expectancy of at least 6 months
- Sufficient genomic DNA available for whole exome sequencing and CLIA validation
- Have a treating oncologist who is participating in the physician study
- Speak English or Spanish
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Insitute
Boston, Massachusetts, 02215
About this study
Official title: CanSeq: Whole-Exome Sequencing (WES) of Cancer Patients
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.
Read more
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.
Read the detailed description
If you agree to take part in this study, we are asking your permission to obtain an additional sample of blood (2 tubes or 4 teaspoons). Cells from the blood contain normal, non-cancer cell DNA which is needed for the analysis.
One of the main reasons to study the genetic characteristics of cancers is to learn whether they can predict response to existing treatments. Therefore, in this study, we would also link the results of gene tests on your cancer wtih medical information that has been generated during the course of your treatment. The medical information is contained in your medical record.
A small number of the gene test results may have importance for your health or treatment. For example, they might uncover gene alterations known to make cancers respond to (or be resistant to) specific therapies. Therefore, we are asking you to consider whether or not you would like us to inform your doctor and you about some of the results of these gene tests.
Your doctor may contact you about results of gene tests, but only if the results could impact your cancer treatment or other disease directly, or if you have given your permission for him or her to do so. In some cases, a research doctor may contact you to find out if you would be interested in participating in a different research study based on information thay may have been found in your tissue or blood samples, or in your survey/interview responses. We will also ask you to provide the name and contact information for a relative who may know your whereabouts, or who could decide about using your information for research in the future, if you are not available to give permission yourself.
Some of your specimens, as well as some of the material generated during the analysis of your tissues or blood, may be useful for study in the future, with newer technologies and approaches. We are asking your permission to store these specimens and materials in a secure biologic sample storage facility for possible later research.
We are also asking you to participate in two surveys related to the study at a few time points. These time points include when you first join the study, and after you receive any results from the gene tests done on your samples. The surveys seek to learn how you are thinking about this type of genetic analysis, and the ways in which the information can be shared with you that would be most helpful.
Some study participants will also be invited to take part in study-related interviews. The purpose of these interviews is to understand what you expect will happen as a result of the gene tests, and how the results of the gene tests may have affected you.
The surveys should take no more than 15 minutes to complete. The interviews are expected to take approximately 45 minutes to complete.
Finally, rapid progress in understanding and treating cancer will occur when some of the genetic information derived from your tissues and blood can be shared with other researchers. In particular, the National Institutes of Health (NIH) and other organizations have developed special data (information) repositories that analyze data and collect the results of certain types of genetic studies. These central banks will store your genetic information, samples, and survey/interview information and provide them to qualified researchers to do more studies. Therefore, we are also asking your permission to share your results with these special banks. Your information or samples will be sent only with a code number attached. Your name or other directly identifiable information will not be shared with data banks or other investigators. There are many safeguards in place to protect your information and samples while they are stored in repositories and used for research. although there may be a slight risk of loss of privacy when sharing this information with these banks, we have established procedures to encode your samples and information and protect your data. Although we will do everything we can to protect the privacy of your data, we cannot absolutely guarantee its privacy or predict how genetic information will be used in the future.
- Conditions
- Lung Adenocarcinoma, Colon Adenocarcinoma
- Keywords
- Metastatic
- Medical subject headings
- Adenocarcinoma of Lung, Colonic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung/Colon Adenocarcinomas | Metastatic lung and colon adenocarcinomas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of WES in Cancer patients
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.
Measured: 2 years
Clinical Impact of Whole Exome Sequencing in Cancer Patients
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.
Measured: 2 years
Describe Impact of Information Derived from Exome Sequencing
To describe the impact of information derived from somatic and germline whole-exome sequencing (WES) on cancer patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startSep 2012
- Primary completionApr 2017
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 244 participants (actual)
- Target duration
- 99 Years
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikhil Wagle, Dana-Farber Cancer Institute
- Investigators
- Nikhil Wagle, MD, Principal investigator, Dana-Farber Cancer Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127359
- Sponsor's protocol ID
- 12-078
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2013
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Gray SW, Park ER, Najita J, Martins Y, Traeger L, Bair E, Gagne J, Garber J, Janne PA, Lindeman N, Lowenstein C, Oliver N, Sholl L, Van Allen EM, Wagle N, Wood S, Garraway L, Joffe S. Oncologists' and cancer patients' views on whole-exome sequencing and incidental findings: results from the CanSeq study. Genet Med. 2016 Oct;18(10):1011-9. doi: 10.1038/gim.2015.207. Epub 2016 Feb 11.
PubMed 26866579
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CanSeq: Whole-Exome Sequencing (WES) of Cancer Patients
- ClinicalTrials.gov ID
- NCT02127359
- Acronym / sponsor ID
- 12-078
- Conditions
- Lung Adenocarcinoma, Colon Adenocarcinoma
- Keywords
- Metastatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2017 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
If you agree to take part in this study, we are asking your permission to obtain an additional sample of blood (2 tubes or 4 teaspoons). Cells from the blood contain normal, non-cancer cell DNA which is needed for the analysis.
One of the main reasons to study the genetic characteristics of cancers is to learn whether they can predict response to existing treatments. Therefore, in this study, we would also link the results of gene tests on your cancer wtih medical information that has been generated during the course of your treatment. The medical information is contained in your medical record.
A small number of the gene test results may have importance for your health or treatment. For example, they might uncover gene alterations known to make cancers respond to (or be resistant to) specific therapies. Therefore, we are asking you to consider whether or not you would like us to inform your doctor and you about some of the results of these gene tests.
Your doctor may contact you about results of gene tests, but only if the results could impact your cancer treatment or other disease directly, or if you have given your permission for him or her to do so. In some cases, a research doctor may contact you to find out if you would be interested in participating in a different research study based on information thay may have been found in your tissue or blood samples, or in your survey/interview responses. We will also ask you to provide the name and contact information for a relative who may know your whereabouts, or who could decide about using your information for research in the future, if you are not available to give permission yourself.
Some of your specimens, as well as some of the material generated during the analysis of your tissues or blood, may be useful for study in the future, with newer technologies and approaches. We are asking your permission to store these specimens and materials in a secure biologic sample storage facility for possible later research.
We are also asking you to participate in two surveys related to the study at a few time points. These time points include when you first join the study, and after you receive any results from the gene tests done on your samples. The surveys seek to learn how you are thinking about this type of genetic analysis, and the ways in which the information can be shared with you that would be most helpful.
Some study participants will also be invited to take part in study-related interviews. The purpose of these interviews is to understand what you expect will happen as a result of the gene tests, and how the results of the gene tests may have affected you.
The surveys should take no more than 15 minutes to complete. The interviews are expected to take approximately 45 minutes to complete.
Finally, rapid progress in understanding and treating cancer will occur when some of the genetic information derived from your tissues and blood can be shared with other researchers. In particular, the National Institutes of Health (NIH) and other organizations have developed special data (information) repositories that analyze data and collect the results of certain types of genetic studies. These central banks will store your genetic information, samples, and survey/interview information and provide them to qualified researchers to do more studies. Therefore, we are also asking your permission to share your results with these special banks. Your information or samples will be sent only with a code number attached. Your name or other directly identifiable information will not be shared with data banks or other investigators. There are many safeguards in place to protect your information and samples while they are stored in repositories and used for research. although there may be a slight risk of loss of privacy when sharing this information with these banks, we have established procedures to encode your samples and information and protect your data. Although we will do everything we can to protect the privacy of your data, we cannot absolutely guarantee its privacy or predict how genetic information will be used in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 99 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung/Colon Adenocarcinomas | – | –Metastatic lung and colon adenocarcinomas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dana-Farber Cancer Institute patients who are identified as oncology patients or patients suspected to have an eligible cancer diagnosis as defined by their providers.
Key inclusion criteria (6 listed)
- Have previously consented to DF/HCC Protocol 11-104, 02-180 and/or are currently receiving clinical testing for KRAS mutations at BWH
- Have a diagnosis of advanced lung or colorectal adenocarcinoma
- Life expectancy of at least 6 months
- Sufficient genomic DNA available for whole exome sequencing and CLIA validation
- Have a treating oncologist who is participating in the physician study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 26866579Gray SW, Park ER, Najita J, Martins Y, Traeger L, Bair E, Gagne J, Garber J, Janne PA, Lindeman N, Lowenstein C, Oliver N, Sholl L, Van Allen EM, Wagle N, Wood S, Garraway L, Joffe S. Oncologists' and cancer patients' views on whole-exome sequencing and incidental findings: results from the CanSeq study. Genet Med. 2016 Oct;18(10):1011-9. doi: 10.1038/gim.2015.207. Epub 2016 Feb 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikhil Wagle, MD principal investigator
Dana-Farber Cancer Insitute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Adenocarcinoma and Colon Adenocarcinoma, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of WES in Cancer patients (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02127359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.