NCT06956248 Innovating Access to Novel Therapies Through Standardized Prospective Integration of Response Evaluations (IMPACT-INSPIRE)
| NCT ID | NCT06956248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Centre, Singapore |
| Condition | Solid Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-09-12 |
| Primary Completion | 2034-09-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-09-12 with a primary completion date of 2034-09-12.
⚠ 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
This observational study aims to assess the outcomes in patients with advanced treatment refractory cancers with matched molecular/precision therapy as per their molecular profiling results after discussion at molecular tumour board. 1. To standardize response assessment and data collection for patients that are receiving off-label or non-standard therapies based on MTB recommendations. \- Establish a standardized response assessment process and data collection patients that are receiving off-label or non-standard therapies based on MTB recommendations. 2. To demonstrate that it is feasible to standardize investigations and endpoints in this proof-of-concept study. * Through standard safety laboratory investigations (FBC, U/E/Cr, LFT) * Through standard radiological imaging at 6-12 weeks with the key endpoint being best response during that imaging window, and disease control rate at 6 months. Hypothesis: Our proposed IMPACT-INSPIRE study hypothesis is that standardised response assessment and data collection in patients with no available therapies receiving off-label systemic therapies, can provide a novel mechanism to assess oncological outcomes in this unique cohort of patients, generate hypothesis, and provide insights to future biomarker-driven drug development
Eligibility Criteria
Inclusion Criteria: 1. Is equal to or greater than 21 years of age; 2. Histologic or cytologic confirmed advanced solid tumours; 3. Patients who have received and failed all standard anticancer therapy (if available) or are unsuitable for further standard anticancer therapy. Cancers with a poor prognosis or low expected response rate to standard treatment (as judged by the investigator on the basis of available evidence) may be screened with respect to an earlier line of treatment; 4. Ability to understand and the willingness to provide written informed consent. Exclusion Criteria: 1. Specific contraindications to exposure to the off-label or non-standard therapy (as defined by the product label); 2. Other comorbid conditions that may compromise assessing key outcomes or, in the judgement of the clinician, limit the ability of the patient to comply with the protocol.
Contact & Investigator
Daniel SW Tan, BSc(Hons), MBBS, MRCP, PhD
PRINCIPAL INVESTIGATOR
National Cancer Centre, Singapore
Frequently Asked Questions
Who can join the NCT06956248 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 99 Years, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06956248 currently recruiting?
Yes, NCT06956248 is actively recruiting participants. Contact the research team at daniel.tan.s.w@singhealth.com.sg for enrollment information.
Where is the NCT06956248 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT06956248 clinical trial?
NCT06956248 is sponsored by National Cancer Centre, Singapore. The principal investigator is Daniel SW Tan, BSc(Hons), MBBS, MRCP, PhD at National Cancer Centre, Singapore. The trial plans to enroll 50 participants.