- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02078544
Integrated Molecular Analysis of Cancer (IMAC)
November 6, 2023 updated by: National University Hospital, Singapore
The purpose of the study is to identify biomarkers and potentially actionable mutations/ activated molecular pathways and evaluate the impact of molecular profiling information on patients with cancer.
The hypothesis of the study are:
- Analysis of tumour samples will allow us to identify novel and/or actionable molecular changes that may drive therapeutic strategies for the management of cancers.
- Molecular profiling will improve the outcome of novel targeted-agent treatment in clinical trials
- Molecular profiling of paired samples (primary/recurrent and primary/metastatic) will provide new insights into mechanisms underlying drug resistance and metastasis in cancers.
Study Overview
Detailed Description
Advances in our understanding of cancer biology has led to a rapid expansion of molecularly targeted therapeutics in pre-clinical and clinical development over the last decade.
The systematic sequencing of cancer genomes has revealed that individual tumours frequently harbor multiple "driver" somatic mutations that confer growth advantage and positive selection.
Importantly, many of the altered proteins resulting from the mutations identified by these studies are in fact actionable, i.e. "druggable", targets.
Hence, evaluating drug efficacy in tumours selected by a combination of histopathology and molecular analysis has the potential to result in a greater therapeutic gain.
The premises behind personalised cancer medicine include: i) genetic aberrations exist in human malignancies; ii) a subset of these aberrations frequently exist across multiple tumour types and have functional relevance as drivers for oncogenesis and tumour progression; iii) the molecular effects of these genetic aberrations are potentially actionable targets; and iv) there are medicinal compounds that can safely and effectively modulate such targets in patients with these tumours.
The key challenge to optimising this personalised approach to cancer therapy is to ensure that patients with tumours harbouring specific molecular/ genetic aberrations are specifically matched to a particular drug or combination of drugs.
In this respect, molecular analysis of tumours to identify somatic mutations and/or other genetic aberrations are examples of enrichment strategies to assist in matching patients to drugs or treatments that have gained increasing interest in the oncology community.
The ability to characterise the unique genetic features of each patient's tumour will be a critical step to identifying the optimal therapeutic strategy for the individual.
Study Type
Observational
Enrollment (Estimated)
1800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shao peng David Tan, MBBS, MRCP, PHD
- Phone Number: (65) 6779 5555
- Email: david_sp_tan@nuhs.edu.sg
Study Locations
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-
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Singapore, Singapore, 119074
- Recruiting
- David Tan Shao Peng
-
Contact:
- Shao peng David Tan, MBBS, MRCP, PHD
- Phone Number: (65) 6779 5555
- Email: david_sp_tan@nuhs.edu.sg
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Principal Investigator:
- Shao peng David Tan, MBBS, MRCP, PHD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients treated with cancers at National University Hospital.
Description
Inclusion Criteria:
- Patients with histological confirmation of cancers who are candidates for systemic therapy, including molecular-targeted therapy/ biomarker-driven clinical trials.
- Patients must be ≥ 21 years old.
- All patients must have signed and dated an informed consent form.
- All patients must have sufficient tumour tissue for molecular profiling
Exclusion Criteria:
Unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
All cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1. Characterization of identified biomarkers and potentially actionable mutations/ activated molecular pathways
Time Frame: 2 years
|
By identifying biomarkers and actionable mutations/molecular pathways in patients and characterizing them, we can evaluate the impact of molecular profiling information on patients with cancer.
The spectrum and development of molecularly targeted agents is rapidly expanding, and it is increasingly likely that the future of cancer management will require the molecular and histological subtype of one's tumor to be defined in order to decide on the most appropriate treatment strategy.
|
2 years
|
To compare progression free survival (PFS) on matched therapy vs non-matched therapy in cancer patients enrolled into molecular targeted therapy/ biomarker-driven clinical trials.
Time Frame: 2 years
|
Progression free survival (PFS) on matched targeted therapy based on molecular profiling compared with PFS on previous non-targeted therapy will be compared to assess the clinical impact of molecular profiling in these patients.
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2 years
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To compare overall response rates (ORR) on matched therapy vs non-matched therapy in cancer patients enrolled into molecular targeted therapy/ biomarker-driven clinical trials.
Time Frame: 2 years
|
Overall response rates (ORR) on matched targeted therapy based on molecular profiling versus non-matched therapy will be compared to assess the clinical impact of molecular profiling in these patients.
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2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov. 2004 Aug;3(8):711-5. doi: 10.1038/nrd1470. No abstract available.
- Stewart DJ, Kurzrock R. Cancer: the road to Amiens. J Clin Oncol. 2009 Jan 20;27(3):328-33. doi: 10.1200/JCO.2008.18.9621. Epub 2008 Dec 8. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
December 9, 2013
First Submitted That Met QC Criteria
March 3, 2014
First Posted (Estimated)
March 5, 2014
Study Record Updates
Last Update Posted (Actual)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 6, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2013/00705 ; 2014/00131
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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