- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04986748
Using QPOP to Predict Treatment for Sarcomas and Melanomas
Q-SAM (Using QPOP to Predict Treatment for Sarcomas and Melanomas)
This is a multi-cohort proof of concept study involving patients with sarcomas or melanomas. Patient models, both two- and three-dimensional, will be derived from tumour samples. These will then be used to evaluate drug sensitivities ex vivo.
Enrolled patients will undergo resections or biopsies as part of standard-of-care, which will be used to generate patient models. Patients will receive standard-of-care systemic treatment. Patient models will also be subjected up to a 14-drug screening panel. The majority of drugs in the respective drug panels has been shown to have activity in the respective cancers and would be used in the standard-of-care setting by treating physicians.
Study Overview
Detailed Description
Hypothesis: Ex vivo drug testing on patient-derived models using QPOP can identify drug sensitivities and combinations which may have clinical efficacy against sarcomas and melanomas.
Specific aim 1: To derive patient models, both two- and three-dimensional, of sarcomas and melanomas
Specific aim 2: To perform ex vivo drug testing on patient models of sarcoma and melanoma using QPOP
Specific aim 3: To assess the efficacy of phenotype directed therapy using QPOP to assign treatment after progression on standard-of-care treatment in sarcoma and melanoma
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Valerie Shiwen Yang, BSc, MB BChir, PhD
- Phone Number: +65 6436 8088
- Email: valerie.yang.s.w@singhealth.com.sg
Study Locations
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Singapore, Singapore, 169610
- Recruiting
- National Cancer Centre Singapore
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Contact:
- Valerie Shiwen Yang, BSc, MB BChir, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of sarcoma or melanoma
- At least 1 tumour lesion amenable to fresh biopsy or resection
- Signed informed consent from patient or legal representative
- Able to comply with study-related procedures
Exclusion Criteria:
- There are no specific exclusion criteria if patients meet the inclusion criteria
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of patients with successful model generation for each tumour subtype.
Time Frame: 8 years.
|
Patients enrolled on study will undergo resection or biopsy of fresh tumour tissue to obtain cells for the generation of models.
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8 years.
|
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Rates of radiological response from QPOP-directed treatment regimens.
Time Frame: 8 years.
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Complete and partial clinical response and stable disease.
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8 years.
|
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Survival outcomes from QPOP-directed treatment regimens.
Time Frame: 8 years.
|
Overall survival, progression-free survival.
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8 years.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Valerie Shiwen Yang, BSc, MB BChir, PhD, National Cancer Centre, Singapore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Q-SAM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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