NCT04611035

Q-GAIN (Using Qpop to Predict Treatment for GAstroIntestinal caNcer)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: Female
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-cohort proof of concept study involving patients with metastatic gastrointestinal cancers. In the first cohort of treatment-naïve patients, the investigators intend to create cancer organoids for 100 subjects. Then, the investigators intend to evaluate ex-vivo prediction of treatment outcomes using QPOP (see section 4.0 for detailed sample size calculation). Patients enrolled on study will undergo a fresh biopsy of tumour lesion to obtain cells that will be used to generate patient-derived tumour organoids. These patients will go on to receive standard of care first-line chemotherapy +/- targeted therapy. Organoids will then be subjected to up to a 14-drug panel screening. The drugs in the respective drug panel have 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 sensitivity testing on patient derived tumour organoids using QPOP can identify drug combinations which may have clinical efficacy against metastatic gastrointestinal cancer. Specific aim 1: To grow patients' gastrointestinal tumour-derived organoids. Specific aim 2: To perform ex-vivo drug sensitivity testing on patient derived tumour organoids using QPOP for metastatic gastrointestinal cancers. Specific aim 3: Asses the efficacy of phenotype directed therapy using QPOP to assign treatment after progression of standard of chemo for gastric cancer.

Conditions

• Gastrointestinal Cancer

Interventions

Type	Name	Description
DEVICE	QPOP	QPOP will then be applied to establish the most efficacious drug combination for the specific organoid. Additional drugs other than those listed above may be screened depending on availability of cancer organoids. When patients progress after first-line treatment, QPOP generated second-line options will be informed to treating physicians and the physician will exercise his/her discretion to select the most suitable drug based on patient's comorbidities and organ function after a formal molecular/phenotype tumour board.

Timeline

• Start date: 2020-01-20
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2020-11-02
• Last updated: 2022-04-06

Locations

1 site across 1 country: Singapore