Advanced CancersNCT02160366
Profile Related Evidence to Determine Individualized Cancer Therapy (PREDICT) Program in Advanced Cancer Patients
An observational study of Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this laboratory research study is to collect and analyze treatment, molecular profiling and biomarker data. The results of the data analysis will be used to better understand how to characterize tumors and identify therapies that may be tailored to individual patients and to identify and/or predict side… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Biomarker Research
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2010to 27 Sep 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred to the Clinical Center for Targeted Therapy at UT MD Anderson Cancer Center in Houston, Texas
Who may be able to join
- 1. All patients referred to the Clinical Center for Targeted Therapy are potentially eligible for recruitment.
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this laboratory research study is to collect and analyze treatment, molecular profiling and biomarker data. The results of the data analysis will be used to better understand how to characterize tumors and identify therapies that may be tailored to individual patients and to identify and/or predict side effects that may occur and/or predict which therapies may be best for participants. Research may also be done on your existing tissue to identify new biomarkers.
Read the detailed description
Molecular Profiling/Deep Sequencing:
Molecular profiling is the classification of tissue based on the expression of certain genes within a tumor that might predict how the tumor responds to therapy. Deep sequencing is a more detailed type of molecular profile that allows for a more focused analysis of individual genes.
Biomarker Data:
A characteristic that is measured and evaluated as an indicator of normal biologic processes, disease processes or pharmacologic responses to a therapeutic intervention.
Study Participation:
If you agree to take part in this study, information from your medical record will be collected. The information that researchers will collect includes your medical history, chemotherapy schedule(s), as well as the results of any tests, procedures, and/or therapies you may have had. Your responses to the therapies, your side effects, and the results of any diagnostic tests performed during therapy will also be collected.
Researchers want to learn if they could have better predicted your response to therapy using the information collected in this study and/or better predict side effects from your treatment.
The data collected from your medical record will be stored in a password-protected database at MD Anderson to be used in research related to this study for up to 10 years.
In addition, research studies on new biomarkers may be conducted on your previously banked blood and/or tumor tissue. Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.
Your name, medical record number, and any other personal identifiable information collected from your medical record will be replaced with a code number. No identifying information will be directly linked to the data collected from your medical record. Only the doctor who is in charge of this study, and select members of their research staff, will have access to the code numbers and be able to link any of the data back to you.
Use of Samples:
Before your banked tissue samples can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your tissue samples from this bank, must first be approved by the IRB.
Your tissue samples will be given a code number. No identifying information will be directly linked to your samples. Only the researcher in charge of the bank will have access to the code numbers and be able to link the samples to you. This is to allow medical data related to the samples to be updated as needed. Other researchers using your samples will not be able to link this data to you.
Length of Study:
Your participation in this study will be over after either the data, blood, tumor tissue samples, and/or archived tumor samples are analyzed.
This is an investigational study.
Up to 2000 participants will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Biomarker Research
- Keywords
- Advanced Cancers, Molecular profiling, Biomarker data, Data analysis, Tumor marker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker ResearchOther
Research studies on new biomarkers conducted on previously banked blood and/or tumor tissue. Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.
| Study group | Role | What they receive |
|---|---|---|
| Biomarker/Molecular Data Collection and Analyzation | Advanced cancer participants Receives: Other: Biomarker Research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Biomarker Profiling to Treatment Outcome
For correlating marker profiles with response to treatment, univariate and multivariate (multiple covariates) logistic regression used, with response status taken as outcome variable. Distributions of time-to-event outcomes estimated using Kaplan-Meier curves, and these distributions compared among groups using log rank test.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study start27 Sep 2010
- Primary completion27 Sep 2020 (estimated)
- Study completion27 Sep 2020 (estimated)
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 Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Filip Janku, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160366
- Sponsor's protocol ID
- LAB10-0441
- Other IDs
- 3UL1RR024148-04S1
- Status last verified
- Jan 2020
- First submitted
- 4 Jun 2014
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weitz J, Nishizaki D, Liau J, Patel J, Ng I, Sun S, Ramms D, Zou J, Wishart B, Rull J, Baumgartner J, Kelly K, White R, Veerapong J, Hosseini M, Patel H, Botta G, Gutkind JS, Tiriac H, Kato S, Lowy AM. Cyclin-Dependent Kinase 4/6 Inhibition as a Novel Therapy for Peritoneal Mucinous Carcinomatosis With GNAS Mutations. J Clin Oncol. 2025 Feb 20;43(6):705-715. doi: 10.1200/JCO.24.00511. Epub 2024 Oct 16.
PubMed 39413348
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profile Related Evidence to Determine Individualized Cancer Therapy (PREDICT) Program in Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT02160366
- Acronym / sponsor ID
- LAB10-0441
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancers, Molecular profiling, Biomarker data, Data analysis, Tumor marker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- 27 Sep 2010 (actual)
- Primary completion
- 27 Sep 2020 (estimated)
- Study completion
- 27 Sep 2020 (estimated)
- First posted
- 10 Jun 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.
The goal of this laboratory research study is to collect and analyze treatment, molecular profiling and biomarker data. The results of the data analysis will be used to better understand how to characterize tumors and identify therapies that may be tailored to individual patients and to identify and/or predict side effects that may occur and/or predict which therapies may be best for participants. Research may also be done on your existing tissue to identify new biomarkers.
Detailed description
Molecular Profiling/Deep Sequencing:
Molecular profiling is the classification of tissue based on the expression of certain genes within a tumor that might predict how the tumor responds to therapy. Deep sequencing is a more detailed type of molecular profile that allows for a more focused analysis of individual genes.
Biomarker Data:
A characteristic that is measured and evaluated as an indicator of normal biologic processes, disease processes or pharmacologic responses to a therapeutic intervention.
Study Participation:
If you agree to take part in this study, information from your medical record will be collected. The information that researchers will collect includes your medical history, chemotherapy schedule(s), as well as the results of any tests, procedures, and/or therapies you may have had. Your responses to the therapies, your side effects, and the results of any diagnostic tests performed during therapy will also be collected.
Researchers want to learn if they could have better predicted your response to therapy using the information collected in this study and/or better predict side effects from your treatment.
The data collected from your medical record will be stored in a password-protected database at MD Anderson to be used in research related to this study for up to 10 years.
In addition, research studies on new biomarkers may be conducted on your previously banked blood and/or tumor tissue. Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.
Your name, medical record number, and any other personal identifiable information collected from your medical record will be replaced with a code number. No identifying information will be directly linked to the data collected from your medical record. Only the doctor who is in charge of this study, and select members of their research staff, will have access to the code numbers and be able to link any of the data back to you.
Use of Samples:
Before your banked tissue samples can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your tissue samples from this bank, must first be approved by the IRB.
Your tissue samples will be given a code number. No identifying information will be directly linked to your samples. Only the researcher in charge of the bank will have access to the code numbers and be able to link the samples to you. This is to allow medical data related to the samples to be updated as needed. Other researchers using your samples will not be able to link this data to you.
Length of Study:
Your participation in this study will be over after either the data, blood, tumor tissue samples, and/or archived tumor samples are analyzed.
This is an investigational study.
Up to 2000 participants will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarker/Molecular Data Collection and Analyzation | – | Other: Biomarker ResearchAdvanced cancer participants |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred to the Clinical Center for Targeted Therapy at UT MD Anderson Cancer Center in Houston, Texas
Key inclusion criteria (1 listed)
- 1. All patients referred to the Clinical Center for Targeted Therapy are potentially eligible for recruitment.
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| Biomarker ResearchResearch studies on new biomarkers conducted on previously banked blood and/or tumor tissue. Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle. | Other | Biomarker/Molecular Data Collection and Analyzation |
Primary outcome
Comparison of Biomarker Profiling to Treatment Outcome
Time frame: 2 months
For correlating marker profiles with response to treatment, univariate and multivariate (multiple covariates) logistic regression used, with response status taken as outcome variable. Distributions of time-to-event outcomes estimated using Kaplan-Meier curves, and these distributions compared among groups using log rank test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Derived from this study: PubMed 39413348Weitz J, Nishizaki D, Liau J, Patel J, Ng I, Sun S, Ramms D, Zou J, Wishart B, Rull J, Baumgartner J, Kelly K, White R, Veerapong J, Hosseini M, Patel H, Botta G, Gutkind JS, Tiriac H, Kato S, Lowy AM. Cyclin-Dependent Kinase 4/6 Inhibition as a Novel Therapy for Peritoneal Mucinous Carcinomatosis With GNAS Mutations. J Clin Oncol. 2025 Feb 20;43(6):705-715. doi: 10.1200/JCO.24.00511. Epub 2024 Oct 16.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Filip Janku, MD, PHD principal investigator
M.D. Anderson Cancer 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 Advanced Cancers, run by M.D. Anderson Cancer 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 1 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: status not confirmed, as of the sponsor's last update on 10 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filip Janku, MD, PHD (713-563-1930, fjanku@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Biomarker Profiling to Treatment Outcome (time frame: 2 months). 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 NCT02160366, 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 Jan 2020.