CancerNCT01061944
Biopsies of Cancer Patients for Tumor Molecular Characterization
An observational study of Cancer and Metastatic Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this research study, we are looking at performing a repeat biopsy of patients' tumors, even though they have already been diagnosed with cancer. The tumor tissue obtained from the biopsy will be studied to see what it looks like at the molecular (genetic) level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Metastatic Cancer
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jan 2018
- 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: Patients will be identified by their oncologist and the service performing the biopsy as a good candidate for the repeat tumor biopsy procedure. Review of the medical record and laboratory data is also performed to ensure the risks of complications are reasonable low and within standard parameters.
Who may be able to join
- Patients must already be known to have metastatic, incurable cancer.
- Patients must have been referred for repeat tumor biopsy as part of standard care and biopsy must have been approved by the appropriate biopsy service (interventional radiology or surgery). Such approval includes review of medical history and laboratory parameters as per standard care.
- 18 years of age or older
- Patients must have previously responded to a molecularly-targeted therapy and subsequently developed resistance, or have an analogous clinical situation in which determining their molecular genotype is of interest clinically and/or scientifically.
- No specific exclusion criteria.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
In this research study, we are looking at performing a repeat biopsy of patients' tumors, even though they have already been diagnosed with cancer. The tumor tissue obtained from the biopsy will be studied to see what it looks like at the molecular (genetic) level. By conducting this study, we hope to learn more about how cancers work, why cancers respond to certain treatments, and how they become resistant to certain treatments. We also hope to demonstrate that biopsies like this can be performed safely in large numbers of patients. The research done on the tumor samples may help us identify which patients in the future are most likely to respond to new cancer therapies.
Read the detailed description
- In order to participate in this research study, participants must have already been diagnosed with cancer. The cancer must be located in a part of the body that is accessible for a biopsy and the doctor that will perform the biopsy must agree that the participant is a good candidate for biopsy. The biopsy will be done in the usual way, as part of your standard medical care.
- After the biopsy, the participant will return to the clinic approximately one week later for a check on their status. At this visit participants will be asked questions about your post-biopsy health. We will continue to follow-up with the participants by phone or at subsequent clinic visits for one month following the biopsy.
- The biopsy obtained will be studied in the Translational Research Laboratory at Massachusetts General Hospital, where it will undergo a panel of genetic tests. These tests look to find out what is driving the cancer or making it tick. It is important to understand that the genetic tests we will do include a number of cancer related genes or proteins that may be important for making treatment decisions, either now or in the future. The test results may or may not show a finding that could affect the participant's treatment options. There will be no specific testing done for inherited genetic abnormalities, so undergoing this research will not give information about the risk of cancer for people in the participant's family.
- If there is left-over tissue from biopsy, it will also be used to try to discover new findings about how cancers respond or become resistant to cancer treatments. These experiments will include trying to grow the cancer cells in a petri dish in the lab or trying to grow the cancer cells inside research mice to learn more about how the cancer works. This portion of the testing os part of the research study and is considered experimental, so the results will not be entered into the participants' medical record.
- Conditions
- Cancer, Metastatic Cancer
- Keywords
- biopsy, tumor biopsy, genetic studies
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility and safety of repeat biopsies for molecular characterization.
Measured: 2 years
Secondary outcomes (2)
To determine the somatic genotype of cancer patients with acquired resistance to a targeted therapy, and to compare these findings with pre-treatment genomic profiled from the same patients.
Measured: 2 years
To estimate the success rate of molecular diagnostics from biopsies specifically obtained for such testing.
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 posted3 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lecia V. Sequist, Massachusetts General Hospital
- Investigators
- Lecia V. Sequist, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061944
- Sponsor's protocol ID
- 09-369
- Status last verified
- Jan 2018
- First submitted
- 2 Feb 2010
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biopsies of Cancer Patients for Tumor Molecular Characterization
- ClinicalTrials.gov ID
- NCT01061944
- Acronym / sponsor ID
- 09-369
- Conditions
- Cancer, Metastatic Cancer
- Keywords
- biopsy, tumor biopsy, genetic studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 3 Feb 2010 (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.
In this research study, we are looking at performing a repeat biopsy of patients' tumors, even though they have already been diagnosed with cancer. The tumor tissue obtained from the biopsy will be studied to see what it looks like at the molecular (genetic) level. By conducting this study, we hope to learn more about how cancers work, why cancers respond to certain treatments, and how they become resistant to certain treatments. We also hope to demonstrate that biopsies like this can be performed safely in large numbers of patients. The research done on the tumor samples may help us identify which patients in the future are most likely to respond to new cancer therapies.
Detailed description
- In order to participate in this research study, participants must have already been diagnosed with cancer. The cancer must be located in a part of the body that is accessible for a biopsy and the doctor that will perform the biopsy must agree that the participant is a good candidate for biopsy. The biopsy will be done in the usual way, as part of your standard medical care.
- After the biopsy, the participant will return to the clinic approximately one week later for a check on their status. At this visit participants will be asked questions about your post-biopsy health. We will continue to follow-up with the participants by phone or at subsequent clinic visits for one month following the biopsy.
- The biopsy obtained will be studied in the Translational Research Laboratory at Massachusetts General Hospital, where it will undergo a panel of genetic tests. These tests look to find out what is driving the cancer or making it tick. It is important to understand that the genetic tests we will do include a number of cancer related genes or proteins that may be important for making treatment decisions, either now or in the future. The test results may or may not show a finding that could affect the participant's treatment options. There will be no specific testing done for inherited genetic abnormalities, so undergoing this research will not give information about the risk of cancer for people in the participant's family.
- If there is left-over tissue from biopsy, it will also be used to try to discover new findings about how cancers respond or become resistant to cancer treatments. These experiments will include trying to grow the cancer cells in a petri dish in the lab or trying to grow the cancer cells inside research mice to learn more about how the cancer works. This portion of the testing os part of the research study and is considered experimental, so the results will not be entered into the participants' medical record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be identified by their oncologist and the service performing the biopsy as a good candidate for the repeat tumor biopsy procedure. Review of the medical record and laboratory data is also performed to ensure the risks of complications are reasonable low and within standard parameters.
Key inclusion criteria (5 listed)
- Patients must already be known to have metastatic, incurable cancer.
- Patients must have been referred for repeat tumor biopsy as part of standard care and biopsy must have been approved by the appropriate biopsy service (interventional radiology or surgery). Such approval includes review of medical history and laboratory parameters as per standard care.
- 18 years of age or older
- Patients must have previously responded to a molecularly-targeted therapy and subsequently developed resistance, or have an analogous clinical situation in which determining their molecular genotype is of interest clinically and/or scientifically.
- No specific exclusion criteria.
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
To determine the feasibility and safety of repeat biopsies for molecular characterization.
Time frame: 2 years
2 secondary outcomes
To determine the somatic genotype of cancer patients with acquired resistance to a targeted therapy, and to compare these findings with pre-treatment genomic profiled from the same patients.
Time frame: 2 years
To estimate the success rate of molecular diagnostics from biopsies specifically obtained for such testing.
Time frame: 2 years
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 26 Jan 2018.
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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.
Lecia V. Sequist, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Metastatic Cancer, run by Massachusetts General Hospital at 1 site 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 5 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 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To determine the feasibility and safety of repeat biopsies for molecular characterization. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2018.