NCT05719428 Neural Network-based Treatment Decision Support Tool in Patients With Refractory Solid Organ Malignancies
| NCT ID | NCT05719428 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National University Hospital, Singapore |
| Condition | Solid Organ Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 37 participants |
| Start Date | 2023-08-28 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 37 participants in total. It began in 2023-08-28 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
DRUID is a treatment decision support tool combining predictive models and public databases related to multi-gene markers, drug response screens, gene essentiality and clinical status of drugs to provide drug recommendations personalized based on an input genomic profile. We hypothesize that DRUID analysis of patients' somatic mutational profile from NGS diagnostic platform can be used as a treatment decision support tool in patients with refractory cancer without targetable mutations.
Eligibility Criteria
Inclusion Criteria: Patients may be included in the study only if they meet all of the following criteria: * Age ≥ 21 years. * Histological or cytological diagnosis solid organ malignancy * Available results of comprehensive NGS panel testing performed on either tumour tissue or blood-based assay. If results are from blood-based assay, test must have been performed in the metastatic setting. * ECOG 0-2. * At least 1 measurable tumour lesions based on RECIST 1.1 criteria * Estimated life expectancy of at least 12 weeks. * Has documented progressive disease from last line of therapy. * Has received at least 2 lines of palliative systemic therapy with no available standard therapy: * Adequate organ function including the following: * Bone marrow: * Absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 109/L * Platelets ≥ 100 x 109/L * Haemoglobin ≥ 8 x 109/L * Hepatic: * Bilirubin ≤ 1.5 x upper limit of normal (ULN), * ALT or AST ≤ 2.5x ULN, (or ≤ 5 X with liver metastases) * Renal: * Creatinine ≤ 1.5x ULN * Signed informed consent from patient or legal representative. * Able to comply with study-related procedures. Exclusion Criteria: * Treatment within the last 30 days with any investigational drug. * Concurrent administration of any other tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy. * Major surgery within 28 days of study drug administration. * Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy. * Pregnancy. * Breast feeding. * Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator. * Active bleeding disorder or bleeding site. * Non-healing wound. * Second primary malignancy that is clinically detectable at the time of consideration for study enrolment. * Symptomatic brain metastasis.
Contact & Investigator
Robert John Walsh
PRINCIPAL INVESTIGATOR
National University Hospital, Singapore
Frequently Asked Questions
Who can join the NCT05719428 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 99 Years, studying Solid Organ Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05719428 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05719428 currently recruiting?
Yes, NCT05719428 is actively recruiting participants. Contact the research team at robert_walsh@nuhs.edu.sg for enrollment information.
Where is the NCT05719428 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT05719428 clinical trial?
NCT05719428 is sponsored by National University Hospital, Singapore. The principal investigator is Robert John Walsh at National University Hospital, Singapore. The trial plans to enroll 37 participants.