Using QPOP to Predict Treatment for Sarcomas and Melanomas

NCT04986748 | Recruiting

• 1 other identifier: Q-SAM
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcoma; Melanoma

Keywords

Tumour-derived models; Organoids; Ex vivo drug testing; Personalised therapy; QPOP

Outcome Measures

Primary Outcomes (3)

• 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.

• Rates of radiological response from QPOP-directed treatment regimens.

  Complete and partial clinical response and stable disease.

  8 years.

• Survival outcomes from QPOP-directed treatment regimens.

  Overall survival, progression-free survival.

  8 years.

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient aged between 21 to 99 diagnosed with sarcoma or melanoma.

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre Singapore

Singapore, 169610, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumour Samples - Baseline upon study enrolment and on disease progression where clinically applicable. Enrolled patients undergoing a procedure where tumour tissue is removed for diagnostic or other clinical purposes, will be asked to donate any tissue that is in excess and not needed for diagnostic purposes, for this research study.

MeSH Terms

Conditions

Sarcoma; Melanoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Valerie Shiwen Yang, BSc, MB BChir, PhD

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Shiwen Yang, BSc, MB BChir, PhD

CONTACT

+65 6436 8088; valerie.yang.s.w@singhealth.com.sg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 3, 2021
• Study Start: September 8, 2020
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)