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Recruiting NCT04986748

Using QPOP to Predict Treatment for Sarcomas and Melanomas

Observational Sarcoma Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sarcoma, Melanoma. Basic parameters: 21 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Q-SAM (Using QPOP to Predict Treatment for Sarcomas and Melanomas)

Overview

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.

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

Primary outcome measures

  • Percentage of patients with successful model generation for each tumour subtype. [Time frame: 8 years.]
  • Rates of radiological response from QPOP-directed treatment regimens. [Time frame: 8 years.]
  • Survival outcomes from QPOP-directed treatment regimens. [Time frame: 8 years.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Singapore · 1 center
  • National Cancer Centre Singapore — Singapore

Identifiers

NCT: NCT04986748 · Q-SAM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗