Using QPOP to Predict Treatment for Sarcomas and Melanomas

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Using QPOP to Predict Treatment for Sarcomas and Melanomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	21 Years - 99 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04986748
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Cancer Centre, Singapore
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Valerie Shiwen Yang, BSc, MB BChir, PhD
Principal Investigator Affiliation	National Cancer Centre, Singapore
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Singapore
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sarcoma, Melanoma

Additional Details

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

Contact a Trial Team

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