Using QPOP to Predict Treatment for Sarcomas and Melanomas

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04986748
• Other study ID #: Q-SAM
• Status: Recruiting
• Start date: September 8, 2020
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2024
• Source: National Cancer Centre, Singapore
• Contact: Valerie Shiwen Yang, BSc, MB BChir, PhD
• Phone: +65 6436 8088
• Email: valerie.yang.s.w[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2028
• Est. primary completion date: October 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Sarcoma

Locations

Country	Name	City	State
Singapore	National Cancer Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with successful model generation for each tumour subtype.	Patients enrolled on study will undergo resection or biopsy of fresh tumour tissue to obtain cells for the generation of models.	8 years.
Primary	Rates of radiological response from QPOP-directed treatment regimens.	Complete and partial clinical response and stable disease.	8 years.
Primary	Survival outcomes from QPOP-directed treatment regimens.	Overall survival, progression-free survival.	8 years.