SarcomaNCT04986748
Using QPOP to Predict Treatment for Sarcomas and Melanomas
An observational study of Sarcoma and Melanoma, run by National Cancer Centre, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Sep 2020to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient aged between 21 to 99 diagnosed with sarcoma or melanoma.
Who may be able to join
- 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
Who cannot join
- There are no specific exclusion criteria if patients meet the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 169610
Valerie Shiwen Yang, BSc, MB BChir, PhD
About this study
Official title: 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.
Read the 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
- Keywords
- Tumour-derived models, Organoids, Ex vivo drug testing, Personalised therapy, QPOP
- Medical subject headings
- Sarcoma, Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 years.
Rates of radiological response from QPOP-directed treatment regimens.
Complete and partial clinical response and stable disease.
Measured: 8 years.
Survival outcomes from QPOP-directed treatment regimens.
Overall survival, progression-free survival.
Measured: 8 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start8 Sep 2020
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie Shiwen Yang, BSc, MB BChir, PhD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986748
- Sponsor's protocol ID
- Q-SAM
- Status last verified
- Jun 2025
- First submitted
- 27 Jul 2021
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Q-SAM (Using QPOP to Predict Treatment for Sarcomas and Melanomas)
- ClinicalTrials.gov ID
- NCT04986748
- Acronym / sponsor ID
- Q-SAM
- Keywords
- Tumour-derived models, Organoids, Ex vivo drug testing, Personalised therapy, QPOP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient aged between 21 to 99 diagnosed with sarcoma or melanoma.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria if patients meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Rates of radiological response from QPOP-directed treatment regimens.
Time frame: 8 years.
Complete and partial clinical response and stable disease.
Survival outcomes from QPOP-directed treatment regimens.
Time frame: 8 years.
Overall survival, progression-free survival.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valerie Shiwen Yang, BSc, MB BChir, PhD principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma and Melanoma, run by National Cancer Centre, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valerie Shiwen Yang, BSc, MB BChir, PhD (+65 6436 8088, valerie.yang.s.w@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with successful model generation for each tumour subtype. (time frame: 8 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.