CancerNCT03098576
Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
An observational study of Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the usefulness of matching patients to targeted therapy by analyzing a tumor sample taken at diagnosis and testing it against 50 cancer-associated genes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Matched targeted drug treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2017to 1 Mar 2024
- 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 with advanced and metastatic solid tumors who have failed standard systemic therapy.
Who may be able to join
- Advanced and metastatic solid tumors who have failed standard treatments known to improve survival
- Female and male adults age 18 and older.
- ECOG PS 0-2
- Acceptable hematological, renal, or liver function
- Patients planning to undergo a systemic treatment
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Who cannot join
- Significant comorbidities that could interfere with the study (compliance and visits)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
The purpose of this study is to examine the usefulness of matching patients to targeted therapy by analyzing a tumor sample taken at diagnosis and testing it against 50 cancer-associated genes. Targeted therapy is a highly personalized, newer approach to cancer treatment that aims to more precisely identify and attack cancer cells, in an effort to do less damage to normal cells.
Read the detailed description
Targeted therapy in this study can be either off label-use of a U.S. Food and Drug Administration (FDA) approved drug or a clinical trial that includes investigational drugs. Matched targeted therapy outcomes will be compared to the outcomes of patients who were not matched to a treatment.
In order to find a matched treatment, a patient's sample will undergo a test known as a "gene chip algorithm." This is will be done by having a sample of a patient's tumor analyzed at a Cedars-Sinai Medical Center (CSMC) laboratory that specializes in molecular profiling. Molecular profiling is a process used to study a tumor's genetic characteristics. DNA will be taken from the tumor sample and will be screened for "actionable genes." These genes are called actionable because mutations (structural changes) in these genes have FDA-approved matched therapies or are eligible for current clinical studies.
- Conditions
- Cancer
- Being tested
- Matched targeted drug treatment, Unmatched standard of care
- Keywords
- advanced, metastatic solid tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matched targeted drug treatmentOther
Matching a specific genetic abnormality (i.e. mutation) with the appropriate targeted drug.
Unmatched standard of careOther
All patients with either no identified mutation or no available matching treatment but undergoing a systemic treatment will be enrolled in the "control group."
| Study group | Role | What they receive |
|---|---|---|
| Matched | Matched targeted drug treatment Receives: Other: Matched targeted drug treatment | |
| Control | Unmatched standard of care Receives: Other: Unmatched standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
To evaluate the proportion of patients with response to targeted study agent(s) in patients with advanced cancers.
Measured: 3 years
Secondary outcomes (2)
Progression free survival
To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced cancers.
Measured: 6 months
Overall survival
Evaluate time until death.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start28 Mar 2017
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
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 Cedars-Sinai Medical CenterThe 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Mita, Cedars-Sinai Medical Center
- Investigators
- Monica Mita, MD, Principal investigator, Cedars-Sinal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098576
- Sponsor's protocol ID
- IIT2015-20-Mita-CSMCMatch
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2017
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
- ClinicalTrials.gov ID
- NCT03098576
- Acronym / sponsor ID
- IIT2015-20-Mita-CSMCMatch
- Conditions
- Cancer
- Keywords
- advanced, metastatic solid tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
The purpose of this study is to examine the usefulness of matching patients to targeted therapy by analyzing a tumor sample taken at diagnosis and testing it against 50 cancer-associated genes. Targeted therapy is a highly personalized, newer approach to cancer treatment that aims to more precisely identify and attack cancer cells, in an effort to do less damage to normal cells.
Detailed description
Targeted therapy in this study can be either off label-use of a U.S. Food and Drug Administration (FDA) approved drug or a clinical trial that includes investigational drugs. Matched targeted therapy outcomes will be compared to the outcomes of patients who were not matched to a treatment.
In order to find a matched treatment, a patient's sample will undergo a test known as a "gene chip algorithm." This is will be done by having a sample of a patient's tumor analyzed at a Cedars-Sinai Medical Center (CSMC) laboratory that specializes in molecular profiling. Molecular profiling is a process used to study a tumor's genetic characteristics. DNA will be taken from the tumor sample and will be screened for "actionable genes." These genes are called actionable because mutations (structural changes) in these genes have FDA-approved matched therapies or are eligible for current clinical studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matched | – | Other: Matched targeted drug treatmentMatched targeted drug treatment |
| Control | – | Other: Unmatched standard of careUnmatched standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced and metastatic solid tumors who have failed standard systemic therapy.
Key inclusion criteria (6 listed)
- Advanced and metastatic solid tumors who have failed standard treatments known to improve survival
- Female and male adults age 18 and older.
- ECOG PS 0-2
- Acceptable hematological, renal, or liver function
- Patients planning to undergo a systemic treatment
Key exclusion criteria (1 listed)
- Significant comorbidities that could interfere with the study (compliance and visits)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Matched targeted drug treatmentMatching a specific genetic abnormality (i.e. mutation) with the appropriate targeted drug. | Other | Matched |
| Unmatched standard of careAll patients with either no identified mutation or no available matching treatment but undergoing a systemic treatment will be enrolled in the "control group." | Other | Control |
Primary outcome
Response rate
Time frame: 3 years
To evaluate the proportion of patients with response to targeted study agent(s) in patients with advanced cancers.
2 secondary outcomes
Progression free survival
Time frame: 6 months
Overall survival
Time frame: 3 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 6 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Monica Mita, MD principal investigator
Cedars-Sinal Medical Center
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, run by Cedars-Sinai Medical Center 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 6 inclusion and 1 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 6 Mar 2024. 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?
Response rate (time frame: 3 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 6 Mar 2024.