CancerNCT02749838
Characterization of Human Cancers by Molecular Profiling of Patient Biospecimens
An observational study of Cancer, run by Pharmatech at 1 site in United States.
Trial summary
Purpose of the Protocol: To prospectively identify cancer patients whose tumors express specific molecular markers targeted by therapeutic agents, for the purpose of selecting the most clinically appropriate anticancer therapy, including clinical trial opportunities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2017
- How long will I take part?
- 1 Year
- 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: There are no restrictions on number, gender, or racial/ethnic orgin of patients enrolled in this study.
Who may be able to join
- Patients who have given informed consent in accordance with the methods and procedures of this study
- Diagnosis of cancer requiring medical care
- Age ≥18 years
- Patients under oncology care of a participating site
- ECOG performance status of 0-3
- Sufficient clinical status for collection of biospecimen samples within usual care
Who cannot join
- Patients considered minors in the jurisdiction where the protocol is conducted
- Patients who are prisoners
- Patients who are employees of the research site
- Relatives of the principal investigator or any participating physician
- Patients with decisional incapacity who cannot understand or comprehend the informed consent form and therefore cannot give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Purpose of the Protocol:
- To prospectively identify cancer patients whose tumors express specific molecular markers targeted by therapeutic agents, for the purpose of selecting the most clinically appropriate anticancer therapy, including clinical trial opportunities.
- To collect and analyze biospecimens from cancer patients, using primarily standard of care laboratory methods, for the purpose of determining the expression of specific genotypic and phenotypic disease markers of scientific and medical interest.
- To create a protocol database, including case and disease stage-matched clinical and therapeutic history data in addition to patient biomarker profiles, to serve as:
- a systematic collection of data for comparing patient data to clinical trial selection criteria for the purpose of informing a clinical investigative site of available clinical trials matching patient clinical status;
- a collection of clinically matched, comprehensive molecular results for scientific and research and development applications.
Read the detailed description
The molecular understanding of cancer is advancing rapidly, and a new generation of more effective, targeted cancer drugs are taking center stage in cancer care. Yet the investigators system for clinical testing of new agents has not kept pace with the revolution in cancer biology.
Stratification by genotypic and phenotypic abnormalities further divides histological cancers into a myriad of clinically distinct subtypes. As cancer therapies become more selective, and the intent to treat populations and the predictability of patient presentation decrease, clinical trial enrollment becomes more difficult by traditional methods. A breakout solution is needed in clinical research methodology, to create a more efficient means of developing new cancer drugs in the US. Improved methods for the systematic, prospective screening of cancer patients are needed to identify the subsets of patients whose tumors express molecular markers targeted by precision therapeutics. This protocol will evaluate clinical samples of cancer tissue to identify the molecular abnormalities present in individual patients' cancer. In this context the investigators objective will be to enable physicians to more thoroughly characterize the molecular abnormalities underlying cancer and to connect eligible patients to precision treatments as part of optimal care.
By making trials more accessible and utilizing technology wisely, it should be possible to match cancer patients to appropriate treatments, including clinical trials, within a clinically relevant timeframe to bring research opportunities into consideration for best clinical care.
- Conditions
- Cancer
- Keywords
- Cancer, Genomic testing, Genetic testing, Molecular screening, Molecular Profiling, Biomarker, Biopsy, Tumor sampling, Registry
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of oncogenic molecular abnormalities by laboratory testing of tumor tissue
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startMay 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Pharmatech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Paradigm
- Responsible party
- Sponsor
- Investigators
- Matthew B Wiener, PharmD, Principal investigator, Pharmatech Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749838
- Sponsor's protocol ID
- PI-13-1008
- Status last verified
- Apr 2016
- First submitted
- 2 Jun 2014
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Human Cancers by Molecular Profiling of Patient Biospecimens
- ClinicalTrials.gov ID
- NCT02749838
- Acronym / sponsor ID
- PI-13-1008
- Conditions
- Cancer
- Keywords
- Cancer, Genomic testing, Genetic testing, Molecular screening, Molecular Profiling, Biomarker, Biopsy, Tumor sampling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (actual)
- Lead sponsor
- PharmatechIndustry (pharma, biotech, devices)
- Collaborators
- Paradigm
- Study start
- May 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 Apr 2016 (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.
Purpose of the Protocol:
- To prospectively identify cancer patients whose tumors express specific molecular markers targeted by therapeutic agents, for the purpose of selecting the most clinically appropriate anticancer therapy, including clinical trial opportunities.
- To collect and analyze biospecimens from cancer patients, using primarily standard of care laboratory methods, for the purpose of determining the expression of specific genotypic and phenotypic disease markers of scientific and medical interest.
- To create a protocol database, including case and disease stage-matched clinical and therapeutic history data in addition to patient biomarker profiles, to serve as:
- a systematic collection of data for comparing patient data to clinical trial selection criteria for the purpose of informing a clinical investigative site of available clinical trials matching patient clinical status;
- a collection of clinically matched, comprehensive molecular results for scientific and research and development applications.
Detailed description
The molecular understanding of cancer is advancing rapidly, and a new generation of more effective, targeted cancer drugs are taking center stage in cancer care. Yet the investigators system for clinical testing of new agents has not kept pace with the revolution in cancer biology.
Stratification by genotypic and phenotypic abnormalities further divides histological cancers into a myriad of clinically distinct subtypes. As cancer therapies become more selective, and the intent to treat populations and the predictability of patient presentation decrease, clinical trial enrollment becomes more difficult by traditional methods. A breakout solution is needed in clinical research methodology, to create a more efficient means of developing new cancer drugs in the US. Improved methods for the systematic, prospective screening of cancer patients are needed to identify the subsets of patients whose tumors express molecular markers targeted by precision therapeutics. This protocol will evaluate clinical samples of cancer tissue to identify the molecular abnormalities present in individual patients' cancer. In this context the investigators objective will be to enable physicians to more thoroughly characterize the molecular abnormalities underlying cancer and to connect eligible patients to precision treatments as part of optimal care.
By making trials more accessible and utilizing technology wisely, it should be possible to match cancer patients to appropriate treatments, including clinical trials, within a clinically relevant timeframe to bring research opportunities into consideration for best clinical care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There are no restrictions on number, gender, or racial/ethnic orgin of patients enrolled in this study.
Key inclusion criteria (6 listed)
- Patients who have given informed consent in accordance with the methods and procedures of this study
- Diagnosis of cancer requiring medical care
- Age ≥18 years
- Patients under oncology care of a participating site
- ECOG performance status of 0-3
Key exclusion criteria (5 listed)
- Patients considered minors in the jurisdiction where the protocol is conducted
- Patients who are prisoners
- Patients who are employees of the research site
- Relatives of the principal investigator or any participating physician
- Patients with decisional incapacity who cannot understand or comprehend the informed consent form and therefore cannot give informed consent
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
Identification of oncogenic molecular abnormalities by laboratory testing of tumor tissue
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Matthew B Wiener, PharmD principal investigator
Pharmatech Inc.
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 Pharmatech 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 5 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 25 Apr 2016. 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?
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?
Identification of oncogenic molecular abnormalities by laboratory testing of tumor tissue (time frame: 60 months). 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 25 Apr 2016.